Back to resultsThis Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder (SYNERGY)
Primary Purpose
Urinary Bladder Overactive, Urinary Bladder Diseases\Urologic Diseases, Overactive Bladder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Solifenacin succinate
Mirabegron
Placebo to match solifenacin succinate
Placebo to match mirabegron
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder Overactive focused on measuring Combination Therapy, Mirabegron, Overactive Bladder, Urgency, Urinary Incontinence, Nocturia, Solifenacin Succinate
Eligibility Criteria
Inclusion Criteria:
- Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
- Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;
Exclusion Criteria:
- Subject had significant PVR volume (> 150 mL);
- Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
- Subject had an indwelling catheter or practices intermittent self catheterization.
- Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
- Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
- Subject had moderate to severe hepatic impairment
- Subject had severe renal impairment
- Subject had a clinically significant abnormal ECG
- Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
- Subject had an average QTcF interval > 450 ms for males or > 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
- Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
Sites / Locations
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- Site DE49001 Private Practice
- Site DE49026 Zentrum fuer Onkologie und Urologie Rostock
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- Site HK85204 The Chinese Uni of HK, Prince of Wales Hospital
- Site HK85201 Kwong Wah Hospital
- Site HK85203 The Chinese Uni of HK, Prince of Wales Hospital
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- Site IT39001 U.O. Dip. di Neuro-Urologia; Univ. di Roma La Sapienza
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- Site KR82001 Seoul Saint Mary's Hospital
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- Site LT37003 Family Medical Centre Seimos gydytojas
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- Site MX52001 Centro de Investigacin Basica y Clnica
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- Site RU70002 Pavlov St. Petersburg State Medical University
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- Site ES34002 H. U. Politecnico La Fe
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- Site TH66009 Srinagarind Hospital
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- Site TR90013 Uludag University Faculty of Medicine
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- Site UA38015 Regional Municipal Institution, Urology Department
- Site UA38013 Dnipropetrovsk State Medical Academy, Mechnikov Dnipropetrov
- Site UA38006 Shapoval Regional Clinical Centre of Urology and Nephrology
- Site UA38007 Central Outpatient Hospital of Deanyanskyy Distric
- Site UA38003 Urology Dpt of Kyiv City Clinical Hospital #3
- Site UA38010 Academy of Medical Sciences of Ukraine
- Site UA38014 Uzhgorod City Polyclinic
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- Site GB44024 St James's University Hospital
- Site GB44025 Kings College Hospital
- Site GB44006 Derriford Hospital
- Site GB44022 The Royal Berkshire Hospital
- Site GB44001 Royal Hallamshire Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1: Solifenacin 5 mg + Mirabegron 25 mg
2: Solifenacin 5 mg + Mirabegron 50 mg
3: Placebo
4: Solifenacin 5 mg
5:Mirabegron 25 mg
6: Mirabegron 50 mg
Arm Description
Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Participants who received matching placebo once a day for 12 weeks.
Participants who received solifenacin 5 mg once a day for 12 weeks.
Participants who received mirabegron 25 mg once a day for 12 weeks.
Participants who received mirabegron 50 mg once a day for 12 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.
Secondary Outcome Measures
Change From Baseline to EoT in Mean Volume Voided Per Micturition
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.
Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT
The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours
Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition
Change From Baseline to EoT in Corrected Micturition Frequency
Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline.
Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Number of Pads Used at Weeks 4, 8, 12 and EoT
The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours
The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT
The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.
Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.
Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day.
Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping
The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern
The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep
The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social
The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT
The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
PGIC Scale: Impression in General Health at Week 12 and EoT
The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment
Change From Baseline to Weeks 4, 8 and 12 in TS-VAS
The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT
The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT
The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT
The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT
The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).
Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT
The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT
The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.
Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume
PVR volume was assessed by ultrasonography or a bladder scanner.
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)
Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)
Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose.
Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.
Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.
Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Full Information
NCT ID
NCT01972841
First Posted
October 25, 2013
Last Updated
October 4, 2018
Sponsor
Astellas Pharma Europe B.V.
1. Study Identification
Unique Protocol Identification Number
NCT01972841
Brief Title
This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder
Acronym
SYNERGY
Official Title
A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 5, 2013 (Actual)
Primary Completion Date
October 22, 2015 (Actual)
Study Completion Date
October 22, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe B.V.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Overactive, Urinary Bladder Diseases\Urologic Diseases, Overactive Bladder, Urgency Incontinence
Keywords
Combination Therapy, Mirabegron, Overactive Bladder, Urgency, Urinary Incontinence, Nocturia, Solifenacin Succinate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3527 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Solifenacin 5 mg + Mirabegron 25 mg
Arm Type
Experimental
Arm Description
Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
Arm Title
2: Solifenacin 5 mg + Mirabegron 50 mg
Arm Type
Experimental
Arm Description
Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Arm Title
3: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who received matching placebo once a day for 12 weeks.
Arm Title
4: Solifenacin 5 mg
Arm Type
Active Comparator
Arm Description
Participants who received solifenacin 5 mg once a day for 12 weeks.
Arm Title
5:Mirabegron 25 mg
Arm Type
Active Comparator
Arm Description
Participants who received mirabegron 25 mg once a day for 12 weeks.
Arm Title
6: Mirabegron 50 mg
Arm Type
Active Comparator
Arm Description
Participants who received mirabegron 50 mg once a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Solifenacin succinate
Other Intervention Name(s)
Vesikur, Vesitrim, YM905, Vesicare
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Mirabegron
Other Intervention Name(s)
YM178, Betmiga, Betanis, Myrbetriq
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo to match solifenacin succinate
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo to match mirabegron
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
Description
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.
Time Frame
Baseline and EoT (up to 12 weeks)
Title
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
Description
A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.
Time Frame
Baseline and EoT (up to 12 weeks)
Secondary Outcome Measure Information:
Title
Change From Baseline to EoT in Mean Volume Voided Per Micturition
Description
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.
Time Frame
Baseline and EoT (up to 12 weeks)
Title
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Description
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.
Time Frame
Baseline and EoT (up to 12 weeks)
Title
Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
Description
The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Time Frame
Baseline and EoT (up to 12 weeks)
Title
Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT
Description
The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes
Time Frame
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
Time Frame
Baseline and weeks 4, 8 and 12
Title
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours
Time Frame
Baseline and weeks 4, 8 and 12
Title
Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition
Time Frame
Baseline and weeks 4, 8 and 12
Title
Change From Baseline to EoT in Corrected Micturition Frequency
Description
Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline.
Time Frame
Baseline and Week 12
Title
Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT
Description
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes
Time Frame
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Description
The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
Description
An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT
Description
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes
Time Frame
Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
Description
The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Number of Pads Used at Weeks 4, 8, 12 and EoT
Description
The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame
Weeks 4, 8 and 12 (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used
Time Frame
Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours
Description
The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame
Baseline and weeks 4, 8 and 12 (up to 12 weeks)
Title
Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT
Description
The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
Description
The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.
Time Frame
Weeks 4, 8,12 and EoT (up to 12 weeks)
Title
Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
Description
The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)
Description
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Time Frame
Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score
Description
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Time Frame
Baseline and weeks 4, 8 and 12
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score
Description
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping
Description
The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern
Description
The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep
Description
The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social
Description
The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT
Description
The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
Time Frame
Week 12 and EoT (up to 12 weeks)
Title
PGIC Scale: Impression in General Health at Week 12 and EoT
Description
The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
Time Frame
Week 12 and EoT (up to 12 weeks)
Title
Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
Description
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time Frame
Baseline and EoT (up to 12 weeks)
Title
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care
Description
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time Frame
Baseline and EoT (up to 12 weeks)
Title
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
Description
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time Frame
Baseline and EoT (up to 12 weeks)
Title
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
Description
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time Frame
Baseline and EoT (up to 12 weeks)
Title
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
Description
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time Frame
Baseline and EoT (up to 12 weeks)
Title
Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
Description
The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Time Frame
Baseline and week 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
Time Frame
Baseline and week 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment
Time Frame
Baseline and week 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment
Time Frame
Baseline and week 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 8 and 12 in TS-VAS
Description
The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Time Frame
Baseline and week 4, 8 and 12
Title
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT
Description
The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT
Description
The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT
Description
The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT
Description
The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT
Description
The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.
Time Frame
Weeks 4, 8 , 12 and EoT (up to 12 weeks)
Title
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT
Description
The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
Description
The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
Description
The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT
Description
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT
Description
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
Description
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
Description
The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
Description
The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Time Frame
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.
Time Frame
From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)
Title
Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume
Description
PVR volume was assessed by ultrasonography or a bladder scanner.
Time Frame
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)
Description
Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Time Frame
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)
Description
Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Time Frame
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)
Description
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Time Frame
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window
Description
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose.
Time Frame
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window
Description
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.
Time Frame
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window
Description
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.
Time Frame
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Title
Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT
Description
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Time Frame
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Title
Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT
Description
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Time Frame
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Title
Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT
Description
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Time Frame
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference
Description
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Time Frame
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference
Description
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Time Frame
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Title
Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference
Description
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Time Frame
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;
Exclusion Criteria:
Subject had significant PVR volume (> 150 mL);
Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
Subject had an indwelling catheter or practices intermittent self catheterization.
Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
Subject had moderate to severe hepatic impairment
Subject had severe renal impairment
Subject had a clinically significant abnormal ECG
Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
Subject had an average QTcF interval > 450 ms for males or > 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Site US10049 Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Site US10112 TFI, LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Site US10104 Clinical Research Advantage, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Site US10021 Beach Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85051
Country
United States
Facility Name
Site US10122 Orange County Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Site US10098 Skyline Research
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Site US10539 Citrus Valley Medical Research
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
Facility Name
Site US10082 American Clinical Trials
City
Hawaiian Gardens
State/Province
California
ZIP/Postal Code
90716
Country
United States
Facility Name
Site US10132 Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Site US10133 Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Site US10536 Stanford School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
93404
Country
United States
Facility Name
Site US10149 Bayview Research Group
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Site US10559 UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Site US10003 San Diego Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Site US10545 San Diego Institute for Sexual Medicine
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Site US10106 West Coast Clinical Research
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Site US10595 Bayview Research Group
City
Valley Village
State/Province
California
ZIP/Postal Code
91607
Country
United States
Facility Name
Site US10034 Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Site US10070 Physicians' Research Options/Red Rocks OB/GYN
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Site US10053 Western Clinical Research, Inc.
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Site US10128 Clinical Research Center of CT
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Site US10018 Grove Hill Clinical Research
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Site US10170 Yale - New Haven Hospital West Haven VAMC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Site US10123 Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Site US10060 Meridien Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Site US10097 A.G.A. Clinical Trials DBA Neostart Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Site US10148 Best Quality Research, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Site US10153 Palmetto Professional Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Site US10159 Urological Research Network
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Site US10534 South Florida Medical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Site US10535 South Florida Medical Research
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Site US10165 East Coast Institute for Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Site US10091 Health Awareness
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Site US10150 Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Site US10158 Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Site US10124 Winter Park Urology Associates
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Site US10134 Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site US10009 South Broward Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Site US10540 Demaur Clinical Research, INC
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Site US10554 Private Practice
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Site US10095 Florida Urology Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Facility Name
Site US10010 Southeastern Research Group, Inc
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Site US10014 Private Practice
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Site US10037 Atlanta Medical Research Institute
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Site US10127 Perimeter North Medical Research, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Site US10120 WR-Mount Vernon Clinical Research
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Site US10024 GTC Research
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Site US10078 Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Site US10088 Centex Studies, Inc.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Site US10074 Medpharmics, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Site US10025 Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Site US10558 Chesapeake Urology Research Associates
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Site US10560 Chesapeake Urology Research Associates
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Site US10282 Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Site US10114 Bay State Clinical Trials, Inc.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Site US10152 Female Pelvic Medicine & Urogynecology Institute
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Site US10542 Adult & Pediatric Urology Group
City
Sartell
State/Province
Minnesota
ZIP/Postal Code
56377
Country
United States
Facility Name
Site US10110 Montana Health Research Institute, Inc.
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Site US10154 Montana Medical Research Inc
City
Missoula
State/Province
Montana
ZIP/Postal Code
59801
Country
United States
Facility Name
Site US10553 Women's Clinic of Lincoln
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Site US10140 IVCTLV
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Site US10002 Urology Center Research Institute
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Site US10051 AdvancedMed Research
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Site US10047 Lawrence OBGYN Associates
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
86480
Country
United States
Facility Name
Site US10162 Phoenix OB-GYN Associates, LLC
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Site US10011 Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Site US10015 Urology Group of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Site US10077 Northeast Urogynecology
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Site US10089 Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Site US10026 AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Site US10040 Premier Medical Group Of The Hudson Valley
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Site US10073 Manhattan Medical Research Practice, PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Site US10249 New York Clinical Trials
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Site US10168 Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Site US10126 Premier Medical Group
City
Newburgh
State/Province
New York
ZIP/Postal Code
12550
Country
United States
Facility Name
Site US10028 Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Site US10593 Upstate Clinical Research Associates LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Site US10076 Carolina Clinical Trials
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Site US10129 PMG Research of Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Site US10549 Associated Urologists of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Site US10062 Piedmont Medical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site US10050 Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Site US10033 Ohio Clinical Research
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Site US10067 Family Practice Center of Wadsworth
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Site US10551 The Christ Hospital
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Site US10109 Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Site US10541 Sunstone Medical Research
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Site US10008 Urologic Consultants of Southeastern Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Site US10045 Lancaster Urology
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Site US10017 Philadelphia Clinical Research, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Site US10167 University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Site US10250 Preferred Primary Care Physicians Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Site US10248 Preferred Primary Care Physicians, Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Site US10063 Preferred Primary Care Physician Research
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Site US10012 Advanced Clinical Concepts
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Site US10166 Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Site US10094 University Medical Group
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Site US10046 Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Site US10079 PMG Research of Charleston, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Site US10117 Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Site US10023 Hillcrest Clinical Research, LLC
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Site US10101 Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Site US10006 Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Site US10084 Dynamed Clinical Research of Austin,LLC dba DM Clinical Resc
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Site US10066 Texas Urology PA
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
Site US10065 Advanced Research Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Site US10085 Centex Studies, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77062
Country
United States
Facility Name
Site US10108 Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Site US10219 Methodist Urology Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Facility Name
Site US10093 Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Site US10090 Protenium Clinical Research, LLC
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Site US10105 Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site US10111 Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site US10092 Physicians' Research Options/Salt Lake Women's Center
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Site US10032 National Clinical Research Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Site US10064 The Group for Women
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Site US10083 Urology of Virginia, PLLC.
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Site US10013 Seattle Urology Research Center
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Site US10004 Integrity Medical Research, LLC
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
Site US10155 Seattle Women's Health, Research, Gynecology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Site US10135 Walla Walla Clinic
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Site AR54005 IUBA - Instituto Urologico de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
1419
Country
Argentina
Facility Name
Site AR54003 Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Site AR54006 Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Site AR54001 CDU - Centro de Urología
City
Ciudad Autónoma Buenos Aires
ZIP/Postal Code
C1120AAT
Country
Argentina
Facility Name
Site AR54004 Instituto de Investigaciones Clnicas Rosario
City
Rosario Provincia De Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Site AU61026 Ballarat Urology
City
Ballarat
ZIP/Postal Code
3350
Country
Australia
Facility Name
Site AU61022 Brisbane South Clinical Research Centre
City
Brisbane
ZIP/Postal Code
4152
Country
Australia
Facility Name
Site AU61005 Hunter Clinical Research
City
Broadmeadow
ZIP/Postal Code
2292
Country
Australia
Facility Name
Site AU61015 Repatriation General Hospital
City
Daw Park
ZIP/Postal Code
5041
Country
Australia
Facility Name
Site AU61025 Western Health
City
Footscray
ZIP/Postal Code
3011
Country
Australia
Facility Name
Site AU61012 Cabrini Hospital
City
Malvern
ZIP/Postal Code
3144
Country
Australia
Facility Name
Site AU61010 Nambour General Hospital
City
Nambour
ZIP/Postal Code
4560
Country
Australia
Facility Name
Site AU61002 The Royal Womens Hospital
City
Parkville
ZIP/Postal Code
3052
Country
Australia
Facility Name
Site AU61004 Keogh Institute for Medical Research
City
Perth
ZIP/Postal Code
6009
Country
Australia
Facility Name
Site AU61007 Prince of Wales Hospital
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Facility Name
Site AU61008 Epworth Healthcare
City
Richmond
ZIP/Postal Code
3121
Country
Australia
Facility Name
Site AU61019 AusTrialsSherwood
City
Sherwood
ZIP/Postal Code
4075
Country
Australia
Facility Name
Site AU61017 Healthpac Medical Centre
City
Sydney
ZIP/Postal Code
2000
Country
Australia
Facility Name
Site AU61021 Royal Hospital for Women
City
Sydney
ZIP/Postal Code
2031
Country
Australia
Facility Name
Site AU61011 Illawarra Health and Medical Research Institute
City
Wollongong
ZIP/Postal Code
2522
Country
Australia
Facility Name
Site BE32004 Gent University Hospital
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Site BE32011 Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Site BE32014 Hart Ziekenhuis
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Site BE32012 Sint-Trudo Ziekenhuis, Campus Sint Jozef/Sint-Anna
City
Sint-Truiden
ZIP/Postal Code
3800
Country
Belgium
Facility Name
Site BG35904 University Hospital (UMHAT) - George Stranski
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Site BG35908 MHAT Plovdiv AD
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Site BG35902 MHAT Ruse
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Site BG35905 MHAT Alexandrovska Hospital
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Site BG35903 MHATEM Pirogov
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Site BG35906 UMHAT Varna
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Site BG35910 MHAT
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Site CA15029 Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Site CA15035 Glenrose Rehabilitation Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2P4
Country
Canada
Facility Name
Site CA15033 Prohealth
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
Site CA15008 Private Practice
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 3J8
Country
Canada
Facility Name
Site CA15001 The Male/Female Health & Research Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Site CA15006 Bramalea Medical Centre
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 4S5
Country
Canada
Facility Name
Site CA15003 Brantford Urology Research
City
Brantford
State/Province
Ontario
ZIP/Postal Code
N3R 4N3
Country
Canada
Facility Name
Site CA15042 G. Kenneth Jansz Medicine Professional Corporation
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Facility Name
Site CA15044 McMaster Institute of Urology
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Site CA15031 Centre for Applied Urology Research (CAUR)
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
Site CA15007 Eunoia2 Incorporated
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
Facility Name
Site CA15034 Oxford/Richmond Medical
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R9
Country
Canada
Facility Name
Site CA15032 Stanley Flax Medical Prof Corp
City
North York
State/Province
Ontario
ZIP/Postal Code
M2J 1V1
Country
Canada
Facility Name
Site CA15013 Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Site CA15004 Primehealth Clinical Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4S 1Y2
Country
Canada
Facility Name
Site CA15002 Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Site CA15026 Rhodin Recherche Clinique
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 7T1
Country
Canada
Facility Name
Site CA15015 Recherches Cliniques Theradev, Inc.
City
Granby
State/Province
Quebec
Country
Canada
Facility Name
Site CA15021 Urology South Shore Research
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H3
Country
Canada
Facility Name
Site CA15030 UroLaval
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7G 2E6
Country
Canada
Facility Name
Site CA15040 RechercheGCP Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2R1V6
Country
Canada
Facility Name
Site CA15020 Diex Research Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 3C5
Country
Canada
Facility Name
Site CA15010 Ultra Med Research, Inc.
City
Point-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Site CA15027 Diex Research Sherbrooke Inc
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Site CA15039 Pro-recherche
City
St-Romuald
State/Province
Quebec
ZIP/Postal Code
G6W 5M6
Country
Canada
Facility Name
Site CA15025 Clinique RSF Inc.
City
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
Facility Name
Site CN86017 Affiliated Union Hospital of Fujian Medical Uni.
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Site CN86025 Beijing Friendship Hospital
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Site CN86009 Peking University 3rd Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Site CN86013 Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Site CN86014 The First Hospital Bethune of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Site CN86002 Changsha Central Hospital
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Site CN86028 General Hospital of Chengdu Military Region of PLA
City
Chengdu
Country
China
Facility Name
Site CN86029 Southwest Hospital (Chongqing)
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Site CN86016 Guangzhou First People's Hospital
City
Guangzhou
ZIP/Postal Code
510180
Country
China
Facility Name
Site CN86027 Second Hospital of Lanzhou University
City
Lan Zhou
ZIP/Postal Code
730030
Country
China
Facility Name
Site CN86030 Lanzhou University First Hospital
City
Lanzhou
Country
China
Facility Name
Site CN86020 The First Affiliated Hospital of NanChang Univers
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Site CN86023 Nanjing First Hospital
City
Nanjing
ZIP/Postal Code
210006
Country
China
Facility Name
Site CN86021 HuaDong Hosipital Affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Site CN86003 Shanghai Renji Hospital
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Site CN86012 The Fifth People's Hospital of Shanghai
City
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
Site CN86011 The Second Affiliated Hospital of Soochow Universi
City
Suzhou
ZIP/Postal Code
215004
Country
China
Facility Name
Site CN86010 1st Affiliated Hosptital of Suchow University
City
Suzhou
ZIP/Postal Code
215006
Country
China
Facility Name
Site CN86026 The First Affiliated Hospital of Wenzhou Medical C
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Facility Name
Site CN86022 Tongji Hospital, Tongji Medical College of Hust
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Site CN86015 Zhongnan Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430071
Country
China
Facility Name
Site CN86018 Wuxi People's Hospital
City
Wuxi
ZIP/Postal Code
214023
Country
China
Facility Name
Site CO57003 Hospital Pablo Tobón Uribe
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Site CO57004 Instituto de Coloproctologia ICO SAS
City
Medellin
Country
Colombia
Facility Name
Site CZ42015 Centrum ambulantni gynekologie a primarni pece
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Site CZ42003 SANUS
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czechia
Facility Name
Site CZ42001 Fakultni Nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Site CZ42002 Hospital Jihlava
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Site CZ42011 Hospital Novy Jicin
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Site CZ42010 G-centrum Olomouc S.R.O.
City
Olomouc
ZIP/Postal Code
772 00
Country
Czechia
Facility Name
Site CZ42014 Private Practice
City
Ostrava
ZIP/Postal Code
700 30
Country
Czechia
Facility Name
Site CZ42005 Research Site s.r.o.
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Facility Name
Site CZ42007 Uro-Santé/Nová Brumlovka
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Site CZ42013 Urology Clinic
City
Sternberk
ZIP/Postal Code
78501
Country
Czechia
Facility Name
Site CZ42009 Hospital Uherské Hradiště a.s.
City
Uherske Hradiste
ZIP/Postal Code
686 08
Country
Czechia
Facility Name
Site CZ42006 Private Practice
City
Usti nad Labem
ZIP/Postal Code
40001
Country
Czechia
Facility Name
Site DK45012 Aalborg Sygehus Nord
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Site DK45013 University Hospital of Aarhus, Skejby
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Site EE37201 Parnu Hospital
City
Parnu
ZIP/Postal Code
80010
Country
Estonia
Facility Name
Site EE37205 West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Site EE37202 Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Site FI35801 Kouvolan Lääkäriasema
City
Kouvola
ZIP/Postal Code
45200
Country
Finland
Facility Name
Site FI35803 Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Facility Name
Site FI35802 Meilahti Hospital
City
Vantaa
ZIP/Postal Code
01400
Country
Finland
Facility Name
Site FR33007 Centre Hospitalier Louis Pasteur
City
Colmar Cedex
ZIP/Postal Code
68024
Country
France
Facility Name
Site FR33010 CHU Hopital du Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Site FR33008 CHU Nantes
City
Nantes Cedex 1
ZIP/Postal Code
44035
Country
France
Facility Name
Site FR33002 CHU Carémeau
City
Nimes Cedex
ZIP/Postal Code
30029
Country
France
Facility Name
Site FR33001 Hopital Tenon
City
Paris Cedex 20
ZIP/Postal Code
75970
Country
France
Facility Name
Site FR33024 Hopital Tenon
City
Paris Cedex 20
ZIP/Postal Code
75970
Country
France
Facility Name
Site FR33013 Hopital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Site FR33011 Centre Hospitalier Lyon Sud
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Site FR33012 Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Site FR33005 Hopital Bretonneau
City
Tours Cedex 9
ZIP/Postal Code
37044
Country
France
Facility Name
Site DE49008 Private Practice
City
Bad Ems
ZIP/Postal Code
56130
Country
Germany
Facility Name
Site DE49031 Urologisches Zentrum Refrath
City
Bergisch Gladbach
ZIP/Postal Code
51427
Country
Germany
Facility Name
Site DE49033 Universitsy Clinic Bonn
City
Bonn
ZIP/Postal Code
53217
Country
Germany
Facility Name
Site DE49002 Private Practice
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
Facility Name
Site DE49032 Urologicum Duisburg
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
Site DE49010 Private Practice
City
Ganderkesee
ZIP/Postal Code
27777
Country
Germany
Facility Name
Site DE49011 Private Practice
City
Halle (Saale)
ZIP/Postal Code
06132
Country
Germany
Facility Name
Site DE49013 Private Practice
City
Leipzig
ZIP/Postal Code
04105
Country
Germany
Facility Name
Site DE49003 Private Practice
City
Lutherstadt Eisleben
ZIP/Postal Code
6295
Country
Germany
Facility Name
Site DE49034 LMU Muenchen
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Site DE49001 Private Practice
City
Neustadt I. Sachsen
ZIP/Postal Code
1844
Country
Germany
Facility Name
Site DE49026 Zentrum fuer Onkologie und Urologie Rostock
City
Rostock
ZIP/Postal Code
18107
Country
Germany
Facility Name
Site DE49014 Private Practice
City
Sangerhausen
ZIP/Postal Code
6526
Country
Germany
Facility Name
Site GR30009 Aretaieio/Maginio
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Site HK85204 The Chinese Uni of HK, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Site HK85201 Kwong Wah Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Site HK85203 The Chinese Uni of HK, Prince of Wales Hospital
City
Shatin
ZIP/Postal Code
30-32
Country
Hong Kong
Facility Name
Site HU36003 Dr.Szarka Ödön Kistérségi Egészségügyi Szolgáltató Kft
City
Csongrád
ZIP/Postal Code
6640
Country
Hungary
Facility Name
Site HU36007 Mediroyal Prevention Center
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Site HU36005 Uro-clin Ltd
City
Pecs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Site HU36013 Sopron Erzsébet Hospital
City
Sopron
ZIP/Postal Code
H-9400
Country
Hungary
Facility Name
Site HU36001 Donatella 99BT
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Site HU36012 Veszprém County Cholnoky Ferenc Hospital
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Site IT39022 Azienda Ospedale Umberto I (Ancona)
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Site IT39007 Azienda Ospedaliera San Giuseppe Moscati
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Site IT39001 U.O. Dip. di Neuro-Urologia; Univ. di Roma La Sapienza
City
Latina
ZIP/Postal Code
4100
Country
Italy
Facility Name
Site IT39020 Ospedale San Raffaele IRCCS, U.O. di Ginecologia e Ostetricia, Unità Funzionale di Uroginecologia
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Site IT39003 Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Site KR82014 Soon Chun Hyang University Hospital
City
Bucheon-Si
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Site KR82006 Dong-A University Medical Center
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Site KR82016 Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Site KR82024 Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
361-711
Country
Korea, Republic of
Facility Name
Site KR82032 Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-421
Country
Korea, Republic of
Facility Name
Site KR82005 Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Site KR82029 Daegu Catholic Univ. Medical Center
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Site KR82019 Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Site KR82011 Eulji University Hospital
City
Daejeon
ZIP/Postal Code
302-799
Country
Korea, Republic of
Facility Name
Site KR82031 Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
501757
Country
Korea, Republic of
Facility Name
Site KR82009 Wonkwang University Hospital
City
Iksan -Si
ZIP/Postal Code
570-711
Country
Korea, Republic of
Facility Name
Site KR82023 Gachon University Gil Hospital
City
Incheon
ZIP/Postal Code
405760
Country
Korea, Republic of
Facility Name
Site KR82010 Chonbuk National University Hospital
City
Jeonju-si
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Site KR82025 Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Site KR82021 Cheil General Hospital & Women's Healthcare Center
City
Seoul
ZIP/Postal Code
100-380
Country
Korea, Republic of
Facility Name
Site KR82020 Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Site KR82030 Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Site KR82013 Hallym University Kangdong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
Facility Name
Site KR82017 Kyung Hee University Medical Center
City
Seoul
ZIP/Postal Code
134-872
Country
Korea, Republic of
Facility Name
Site KR82002 Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Site KR82008 Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Site KR82015 Korea University Medical Center
City
Seoul
ZIP/Postal Code
136-075
Country
Korea, Republic of
Facility Name
Site KR82001 Seoul Saint Mary's Hospital
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Facility Name
Site KR82003 Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Site KR82012 Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Site KR82004 Ajou University Hospital
City
Suwon-si
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Site LV37102 Private Practice
City
Liepaja
ZIP/Postal Code
LV-3401
Country
Latvia
Facility Name
Site LV37103 Health Centre "Olaine"
City
Olaine
ZIP/Postal Code
LV-2114
Country
Latvia
Facility Name
Site LV37105 P.Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Site LT37008 Kaunas 2nd Clinical Hospital
City
Kaunas
ZIP/Postal Code
47144
Country
Lithuania
Facility Name
Site LT37004 KHospital of Lithuanian University of Health Science
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Site LT37011 Saules Family Medicine Centre
City
Kaunas
Country
Lithuania
Facility Name
Site LT37012 Klaipeda University Hospital
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Site LT37005 Public Institution Vilnius City University Hospital
City
Vilnius
ZIP/Postal Code
10207
Country
Lithuania
Facility Name
Site LT37010 Public Institution Vilnius City University Hospital
City
Vilnius
ZIP/Postal Code
10207
Country
Lithuania
Facility Name
Site LT37003 Family Medical Centre Seimos gydytojas
City
Vilnius
ZIP/Postal Code
LT-01118
Country
Lithuania
Facility Name
Site LT37007 Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Site LT37009 Clinics Privatus gydytojas
City
Vilnius
ZIP/Postal Code
LT-09108
Country
Lithuania
Facility Name
Site MY60006 Hospital Pulau Pinang
City
Georgetown
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Site MY60001 Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Site MY60004 University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Site MY60005 Universiti Kebangsaan Malaysia Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Site MY60003 Hospital Ummum Sarawak
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Site MY60002 Sime Darby Medical Centre
City
Petaling Jaya
ZIP/Postal Code
47500
Country
Malaysia
Facility Name
Site MX52004 Consultorio de Especialidad en Urologia
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Site MX52001 Centro de Investigacin Basica y Clnica
City
Guadalajara
ZIP/Postal Code
45040
Country
Mexico
Facility Name
Site MX52003 Clinstile, Sociedad Anonima de Capital Variable
City
Mexico City
ZIP/Postal Code
6700
Country
Mexico
Facility Name
Site MX52002 Accelerium Clinical Research/ Hospital San Jorge
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Site NL31002 Academic Medical Center (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Site NL31006 Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7513ER
Country
Netherlands
Facility Name
Site NL31005 Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Site NL31010 Antonius Ziekenhuis Sneek
City
Sneek
ZIP/Postal Code
8601 ZK
Country
Netherlands
Facility Name
Site NL31001 University Medical Centre Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Site NZ64004 John A Tuckey Ltd Ascot Central
City
Auckland
ZIP/Postal Code
1541
Country
New Zealand
Facility Name
Site NZ64001 Canterbury Urology Research Trust
City
Christchurch
ZIP/Postal Code
8014
Country
New Zealand
Facility Name
Site NZ64005 Waikato Urology Research Limited
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Site NZ64002 Roundhay Medical Centre
City
Nelson
ZIP/Postal Code
7010
Country
New Zealand
Facility Name
Site NZ64003 Tauranga Urology Research Ltd
City
Tauranga
ZIP/Postal Code
3140
Country
New Zealand
Facility Name
Site NZ64006 Cardinal Point Specialist Centre
City
Whangarei
Country
New Zealand
Facility Name
Site NO47006 M3 Helse AS
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
Site NO47008 Norsk Helseklinikk (Heiaklinikken)
City
Lierskogen
ZIP/Postal Code
3420
Country
Norway
Facility Name
Site NO47007 Medi3 Clinic AS, Ålesund
City
Ålesund
ZIP/Postal Code
6003
Country
Norway
Facility Name
Site PE51006 Hospital Nacional Guillermo Almenara Irigoyen EsSalud
City
La Victoria
State/Province
Lima
ZIP/Postal Code
13
Country
Peru
Facility Name
Site PE51007 Clínica Anglo Americana
City
San Isidro
State/Province
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Site PE51001 Instituto de Ginecologia y Reproduccion
City
Lima
ZIP/Postal Code
33
Country
Peru
Facility Name
Site PE51002 Clinica San Borja
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
Site PE51004 Clinica San Pablo
City
Lima
Country
Peru
Facility Name
Site PE51005 Hospital Nacional Hipolito Unanue
City
Lima
Country
Peru
Facility Name
Site PH63008 Dr. Pablo O. Torre Memorial Hospital
City
Bacolod City
ZIP/Postal Code
6100
Country
Philippines
Facility Name
Site PH63005 Davao Doctor's Hospital
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Site PH63010 Davao Doctor's Hospital
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Site PH63003 University of Santo Tomas Hospital (USTH)
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Site PH63009 Chinese General Hospital and Medical Center
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Site PH63004 East Avenue Medical Center
City
Quezon City
ZIP/Postal Code
1101
Country
Philippines
Facility Name
Site PL48018 Gastromed
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Site PL48013 Urovita Ltd.
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Site PL48014 Synexus Polska
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Site PL48004 NZOZ Szpital Sw.Rodziny Centrum Medyczne
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Site PL48010 Nzoz Novita
City
Lublin
ZIP/Postal Code
20-632
Country
Poland
Facility Name
Site PL48011 Nzoz Centrum Urologiczne sp. z o.o.
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Site PL48016 Prywatny Gabinet Urologiczny
City
Opole
ZIP/Postal Code
45-086
Country
Poland
Facility Name
Site PL48005 HEUREKA Hanna Szalecka
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Facility Name
Site PL48012 Military Institute of Medicine
City
Warsaw
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Site PL48003 CSKMSW
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Site PL48001 Specjalistyczny Gabinet Lekarski
City
Warszawa
ZIP/Postal Code
02-929
Country
Poland
Facility Name
Site PL48019 Synexus Polska sp. z o. o.
City
Wrocław
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Site RO40015 Spitaul Clinic Judetean de Urgenta Brasov
City
Brasov
ZIP/Postal Code
500152
Country
Romania
Facility Name
Site RO40004 Spitalul Clinic de Urgenta Sfantul Ioan
City
Bucuresti
ZIP/Postal Code
42122
Country
Romania
Facility Name
Site RO40001 Spiatlul Clinic Th. Burghele
City
Bucuresti
ZIP/Postal Code
50659
Country
Romania
Facility Name
Site RO40005 Spiatlul Clinic Th. Burghele
City
Bucuresti
ZIP/Postal Code
50659
Country
Romania
Facility Name
Site RO40014 E-URO Cabinet
City
Cluj-Napoca
ZIP/Postal Code
400046
Country
Romania
Facility Name
Site RO40007 Spital Clinic
City
Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
Site RO40010 Spitalul Clinic Judetan de Urgenta Sibiu
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Site RO40002 Spitalul Clinic Judetean de Urgenta Timisoara
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Site RU70015 LLC Clinical Research Medical Complex
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
Facility Name
Site RU70023 Penza Regional Clinical Hospatal n. a. N.N. Burdenko
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
Site RU70019 City Multidisciplinary Hospital No. 2
City
Saint Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Site RU70002 Pavlov St. Petersburg State Medical University
City
Saint Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Site RU70022 St. Petersburg State Public Health Institution
City
Saint Petersburg
ZIP/Postal Code
198103
Country
Russian Federation
Facility Name
Site RU70014 OOO Hospital Orkli
City
St. Petersburg
ZIP/Postal Code
199178
Country
Russian Federation
Facility Name
Site RU70018 Bashkirsky State Medical University of Roszdrav
City
Ufa
ZIP/Postal Code
450096
Country
Russian Federation
Facility Name
Site SG65001 National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Site SG65002 Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Site SG65003 KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
Site SK42105 Ruzinovska poliklinika a.s.
City
Bratislava
ZIP/Postal Code
82101
Country
Slovakia
Facility Name
Site SK42107 Zeleznicne zdravotnictvo Kosice, s.r.o.
City
Kosice
ZIP/Postal Code
4001
Country
Slovakia
Facility Name
Site SK42101 Andrologicka a Urologicka Ambulancia
City
Kosice
ZIP/Postal Code
4013
Country
Slovakia
Facility Name
Site SK42103 UroExam s.r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Site SK42108 BrenCare, s. r. o.
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Site SK42104 Urology Outpatient Department
City
Presov
ZIP/Postal Code
8001
Country
Slovakia
Facility Name
Site SK42106 Private Urological Care Center
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
Site SK42102 CeGys, s.r.o.
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
Facility Name
Site SI38604 General Hospital Murska Sobota
City
Murska Sobota
ZIP/Postal Code
9000
Country
Slovenia
Facility Name
Site SI38602 General Hospital Novo Mesto
City
Novo Mesto
ZIP/Postal Code
8000
Country
Slovenia
Facility Name
Site ZA27005 Grootte Schuur Hospital
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Site ZA27001 Private Practice
City
Centurion
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Site ZA27006 Parklands Hospital
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Site ZA27013 Synexus Clinical Research SA (Pty) Ltd
City
Meyerspark
ZIP/Postal Code
184
Country
South Africa
Facility Name
Site ZA27007 Paarl Medical Centre
City
Paarl
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Site ZA27002 Mayo Clinic
City
Roodepoort
ZIP/Postal Code
1709
Country
South Africa
Facility Name
Site ES34010 Hospital del Henares
City
Coslada
ZIP/Postal Code
28822
Country
Spain
Facility Name
Site ES34024 Hospital San Juan de Dios
City
Esplugues De Llobregat-Barcelo
ZIP/Postal Code
08950
Country
Spain
Facility Name
Site ES34001 Hospital Universitario de Getafe
City
Getafe (Madrid)
ZIP/Postal Code
28905
Country
Spain
Facility Name
Site ES34006 Hospital San Rafael
City
Madrid
ZIP/Postal Code
28016
Country
Spain
Facility Name
Site ES34004 Hospital Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Site ES34015 Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28044
Country
Spain
Facility Name
Site ES34009 Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Site ES34005 Hospital de Fuenlabrada
City
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Site ES34003 Hospital Universitario Nuestra Señora de Valme
City
Sevilla
ZIP/Postal Code
41001
Country
Spain
Facility Name
Site ES34007 Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Site ES34002 H. U. Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Site SE46007 Ladulaas Clinical Studies
City
Boras
ZIP/Postal Code
506 30
Country
Sweden
Facility Name
Site SE46025 Pharmasite
City
Helsingborg
ZIP/Postal Code
252 20
Country
Sweden
Facility Name
Site SE46005 Center för Läkemedelsstudier
City
Malmö
ZIP/Postal Code
211 52
Country
Sweden
Facility Name
Site SE46016 Citydiabetes - Stockholm
City
Stockholm
ZIP/Postal Code
111 57
Country
Sweden
Facility Name
Site SE46008 Bragée Medect AB
City
Stockholm
ZIP/Postal Code
115 22
Country
Sweden
Facility Name
Site SE46012 Karolinska University Hospital Huddinge
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Site SE46003 Danderyds Hospital
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Site SE46009 Encia AB, Uppsala Hälsomottagning
City
Uppsala
ZIP/Postal Code
753 35
Country
Sweden
Facility Name
Site SE46017 S3 Clinical Research Centers
City
Vällingby
ZIP/Postal Code
162 68
Country
Sweden
Facility Name
Site TW88605 Taichung Veteran General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Site TW88611 Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Site TW88612 Chi Mei Medical Center, Yong Kang
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
Site TW88614 Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Site TH66002 Chulalongkorn Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Site TH66008 Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Site TH66005 Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Site TH66010 Maharaj Nakorm Chiangmai Hosp
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Site TH66006 Songklanagarind Hospital, Prince of Songkla University
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Site TH66009 Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Site TH66007 Thammasat University Hospital
City
Pathum Thani
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Site TH66011 Ramathibodi Hospital
City
Ratchathewi
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Site TR90019 Ankara University Medical Faculty Ibni Sina Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Site TR90013 Uludag University Faculty of Medicine
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Site TR90001 Pamukkale University Faculty of Medicine
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Site TR90017 Bilim University Sisli Florence Nightingale Hospital
City
Istanbul
ZIP/Postal Code
34381
Country
Turkey
Facility Name
Site UA38002 City Hospital No 2
City
Chernigov
ZIP/Postal Code
14034
Country
Ukraine
Facility Name
Site UA38015 Regional Municipal Institution, Urology Department
City
Chernivtsi
ZIP/Postal Code
58000
Country
Ukraine
Facility Name
Site UA38013 Dnipropetrovsk State Medical Academy, Mechnikov Dnipropetrov
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Site UA38006 Shapoval Regional Clinical Centre of Urology and Nephrology
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Site UA38007 Central Outpatient Hospital of Deanyanskyy Distric
City
Kiev
ZIP/Postal Code
02232
Country
Ukraine
Facility Name
Site UA38003 Urology Dpt of Kyiv City Clinical Hospital #3
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Site UA38010 Academy of Medical Sciences of Ukraine
City
Kyiv
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
Site UA38014 Uzhgorod City Polyclinic
City
Uzhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Site UA38004 Vinnitsa Endocrinology Dispens
City
Vinnytsya
ZIP/Postal Code
21010
Country
Ukraine
Facility Name
Site UA38008 Medical Academy of Postgraduate Education, Urology Clinic
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Site GB44009 Sheepcot Medical Centre
City
Garston
State/Province
Watfort
ZIP/Postal Code
WD25 0EA
Country
United Kingdom
Facility Name
Site GB44003 Leighton Hospital
City
Crewe
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Facility Name
Site GB44021 Medway Hospital
City
Gillingham
ZIP/Postal Code
ME7 5WY
Country
United Kingdom
Facility Name
Site GB44005 North West London Hosp Menopause Clinic
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Site GB44024 St James's University Hospital
City
Leeds
ZIP/Postal Code
LS7 9TF
Country
United Kingdom
Facility Name
Site GB44025 Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Site GB44006 Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Site GB44022 The Royal Berkshire Hospital
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Site GB44001 Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=254
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder
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