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A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder (Symphony)

Primary Purpose

Urologic Diseases, Urinary Bladder Diseases, Urological Manifestations

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Mirabegron
Solifenacin succinate
Placebo
Sponsored by
Astellas Pharma Europe B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urologic Diseases focused on measuring Urinary incontinence, Overactive bladder (OAB), Micturition, Frequency, YM178, Urgency incontinence, Urgency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion Criteria at Visit 1/Screening:

    • Subject has a Body Mass Index (BMI) of between 18 and 35 kg/m^2 and a total body weight between 50 and 95 kg;
    • Subject is willing and able to complete the micturition diary and questionnaires correctly and is willing 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 has symptoms of overactive bladder (OAB; urinary frequency, urgency and/or urgency incontinence) for at least 3 months.
  • Inclusion Criteria at Visit 3/Baseline:

    • Subject has experienced frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period (incontinence episode should not be counted as a micturition);
    • Subject must experience at least 1 episode of urgency (grade 3 or 4) per 24-hour period (with or without urgency incontinence) during the 3 day micturition diary period.

Exclusion Criteria:

  • Exclusion Criteria at Visit 1/Screening:

    • Subject is breastfeeding, pregnant or intends to become pregnant during the study. The pregnancy test (Beta Human Chorionic Gonadotropin in serum) at Screening must be negative in women of childbearing potential;
    • Female subjects of childbearing potential and not using a highly effective method of birth control during the study and for 30 days after final study drug administration.
    • Male subjects (unless surgically sterile) with female spouses/partners who are of childbearing potential, and not using a barrier method of contraception during the study and for 30 days after final study drug administration. In addition, female spouses/partners of male subjects and who are of childbearing potential should also use a highly effective method of birth control during the study and for 30 days after final study drug administration. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.
    • Subject has significant post-void residual (PVR) volume (> 150 mL);
    • Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by the cough provocation test);
    • Subject has a neurological cause for detrusor overactivity;
    • Subject has an indwelling catheter or practices intermittent self-catheterization;
    • Subject has diabetic neuropathy;
    • Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
    • Subject has had previous lower urinary tract or pelvic floor surgery (except cystoscopy);
    • Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
    • Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis or Crohn's Disease, toxic megacolon, myasthenia gravis or any other condition which makes the use of anticholinergics contraindicated;
    • Subject has clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Screening, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure and stroke;
    • Subject is receiving current non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to Screening);
    • Subject is using medications intended to treat OAB or prohibited medications.
    • Subject has known or suspected hypersensitivity to solifenacin succinate, mirabegron or any of their excipients;
    • Subject has any significant neurological disease or defect affecting bladder function (e.g., neurogenic bladder, systemic or central neurological disease such as multiple sclerosis [MS] and Parkinson's disease);
    • Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg;
  • Exclusion Criteria at Visit 2/Placebo Run-In:

    • Subject has evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL). The subject can be enrolled into the study after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture). However, the subject must be re screened if the initial screening visit was > 28 days;
    • Subject has a QT interval > 450 ms or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia) or is on drug treatment known to be associated with QT prolongation;
    • Subject has clinically significant abnormalities on the 12 lead electrocardiogram (ECG);
    • Subject has serum creatinine > 150 µmol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal (ULN), gamma-glutamyltransferase (γ-GT) > 3x ULN, or total bilirubin > 2x ULN, as assessed in Screening samples;
  • Exclusion Criteria at Visit 3/Baseline:

    • Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary period;
    • Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg.

Sites / Locations

  • BY37101
  • BY37102
  • BY37103
  • BY37104
  • BE32102
  • BE32104
  • BE32103
  • BE32101
  • CZ42005
  • CZ42003
  • CZ42011
  • CZ42006
  • CZ42007
  • CZ42001
  • CZ42009
  • CZ42010
  • CZ42012
  • CZ42002
  • DK45101
  • DK45102
  • DK45104
  • FI35803
  • FI35804
  • FI35801
  • FI35802
  • FR33104
  • FR33108
  • FR33103
  • FR33111
  • FR33112
  • FR33106
  • FR33110
  • DE49109
  • DE49103
  • DE49117
  • DE49105
  • DE49108
  • DE49110
  • DE49118
  • DE49101
  • DE49111
  • DE49104
  • HU36108
  • HU36101
  • HU36106
  • HU36110
  • HU36104
  • HU36103
  • HU36107
  • IT39103
  • IT39101
  • IT39105
  • IT39102
  • NL31104
  • NL31106
  • NL31102
  • NL31101
  • NO47104
  • NO47102
  • PL48107
  • PL48103
  • PL48108
  • PL48106
  • PL48104
  • PL48101
  • PL48105
  • PL48112
  • PL48111
  • PT35102
  • PT35105
  • PT35104
  • PT35107
  • PT35110
  • PT35101
  • PT35106
  • RO40106
  • RO40102
  • RO40104
  • RO40103
  • RO40108
  • RO40101
  • RO40105
  • RO40107
  • RU70112
  • RU70108
  • RU70110
  • RU70102
  • RU70103
  • RU70101
  • RU70107
  • RU70106
  • RU70109
  • RU70113
  • SK42109
  • SK42112
  • SK42107
  • SK42113
  • SK42104
  • SK42106
  • SK42105
  • SK42102
  • SK42108
  • SK42101
  • SK42103
  • ES34103
  • ES34101
  • ES34109
  • ES34102
  • ES34105
  • ES34104
  • ES34107
  • SE46101
  • SE46103
  • SE46104
  • SE46102
  • SE46105
  • UA38104
  • UA38102
  • UA38111
  • UA38106
  • UA38109
  • UA38107
  • UA38101
  • UA38103
  • GB44103
  • GB44108
  • GB44106
  • GB44111
  • GB44104
  • GB44110
  • GB44107
  • GB44101
  • GB44105

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Mirabegron 25 mg

Mirabegron 50 mg

Solifenacin 2.5 mg

Solifenacin 5 mg

Solifenacin 10 mg

Solifenacin 2.5 mg and Mirabegron 25 mg

Solifenacin 2.5 mg and Mirabegron 50 mg

Solifenacin 5 mg and Mirabegron 25 mg

Solifenacin 5 mg and Mirabegron 50 mg

Solifenacin 10 mg and Mirabegron 25 mg

Solifenacin 10 mg and Mirabegron 50 mg

Arm Description

Participants received matching placebo tablets orally once a day for 12 weeks

Participants received mirabegron 25 mg tablets orally once a day for 12 weeks

Participants received mirabegron 50 mg tablets orally once a day for 12 weeks

Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks

Participants received solifenacin 5 mg tablets orally once a day for 12 weeks

Participants received solifenacin 10 mg tablets orally once a day for 12 weeks

Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks

Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks

Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks

Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks

Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks

Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks

Outcomes

Primary Outcome Measures

Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.

Secondary Outcome Measures

Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.
Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Percentage of Participants With a Micturition Response
A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.
Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Percentage of Participants With Zero Incontinence Episodes Post-baseline
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.
Percentage of Participants With 50% Reduction in Incontinence Episodes
The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.
Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.
Change From Baseline to Each Visit in Mean Level of Urgency
Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.
Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.
Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.
Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.
Percentage of Participants With Improvement in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.
Percentage of Participants With Major Improvement in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.
Percentage of Participants With Deterioration in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.
Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.
Percentage of Participants With a Symptom Bother Response
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.
Percentage of Participants With a Health-related Quality of Life Total Score Response
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category.
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.
Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.
Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.

Full Information

First Posted
April 20, 2011
Last Updated
December 17, 2019
Sponsor
Astellas Pharma Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01340027
Brief Title
A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder
Acronym
Symphony
Official Title
A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 29, 2011 (Actual)
Primary Completion Date
June 28, 2012 (Actual)
Study Completion Date
June 28, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe B.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases, Urinary Bladder Diseases, Urological Manifestations, Signs and Symptoms, Urinary Bladder, Overactive
Keywords
Urinary incontinence, Overactive bladder (OAB), Micturition, Frequency, YM178, Urgency incontinence, Urgency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received matching placebo tablets orally once a day for 12 weeks
Arm Title
Mirabegron 25 mg
Arm Type
Active Comparator
Arm Description
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks
Arm Title
Mirabegron 50 mg
Arm Type
Active Comparator
Arm Description
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
Arm Title
Solifenacin 2.5 mg
Arm Type
Active Comparator
Arm Description
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks
Arm Title
Solifenacin 5 mg
Arm Type
Active Comparator
Arm Description
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks
Arm Title
Solifenacin 10 mg
Arm Type
Active Comparator
Arm Description
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks
Arm Title
Solifenacin 2.5 mg and Mirabegron 25 mg
Arm Type
Experimental
Arm Description
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Arm Title
Solifenacin 2.5 mg and Mirabegron 50 mg
Arm Type
Experimental
Arm Description
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Arm Title
Solifenacin 5 mg and Mirabegron 25 mg
Arm Type
Experimental
Arm Description
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Arm Title
Solifenacin 5 mg and Mirabegron 50 mg
Arm Type
Experimental
Arm Description
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Arm Title
Solifenacin 10 mg and Mirabegron 25 mg
Arm Type
Experimental
Arm Description
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Arm Title
Solifenacin 10 mg and Mirabegron 50 mg
Arm Type
Experimental
Arm Description
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Mirabegron
Other Intervention Name(s)
Betmiga, Myrbetric, Myrbetriq, Betanis, YM178
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Solifenacin succinate
Other Intervention Name(s)
Vesikur, Vesicare
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition
Description
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
Description
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Description
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
Description
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
Description
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Percentage of Participants With a Micturition Response
Description
A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
Description
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Percentage of Participants With Zero Incontinence Episodes Post-baseline
Description
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.
Time Frame
Weeks 2, 4, 8 and 12
Title
Percentage of Participants With 50% Reduction in Incontinence Episodes
Description
The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Description
Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
Description
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline to Each Visit in Mean Level of Urgency
Description
Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
Description
The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
Description
Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)
Description
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With Improvement in PPBC
Description
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With Major Improvement in PPBC
Description
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With Deterioration in PPBC
Description
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
Description
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With a Symptom Bother Response
Description
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score
Description
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With a Health-related Quality of Life Total Score Response
Description
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.
Time Frame
Baseline and Week 12
Title
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Description
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Time Frame
Baseline and Week 12
Title
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Description
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Time Frame
Baseline and Week 12
Title
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Description
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Time Frame
Baseline and Week 12
Title
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Description
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category.
Time Frame
Baseline and Week 12
Title
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Description
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
Description
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
Description
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
Description
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria at Visit 1/Screening: Subject has a Body Mass Index (BMI) of between 18 and 35 kg/m^2 and a total body weight between 50 and 95 kg; Subject is willing and able to complete the micturition diary and questionnaires correctly and is willing 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 has symptoms of overactive bladder (OAB; urinary frequency, urgency and/or urgency incontinence) for at least 3 months. Inclusion Criteria at Visit 3/Baseline: Subject has experienced frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period (incontinence episode should not be counted as a micturition); Subject must experience at least 1 episode of urgency (grade 3 or 4) per 24-hour period (with or without urgency incontinence) during the 3 day micturition diary period. Exclusion Criteria: Exclusion Criteria at Visit 1/Screening: Subject is breastfeeding, pregnant or intends to become pregnant during the study. The pregnancy test (Beta Human Chorionic Gonadotropin in serum) at Screening must be negative in women of childbearing potential; Female subjects of childbearing potential and not using a highly effective method of birth control during the study and for 30 days after final study drug administration. Male subjects (unless surgically sterile) with female spouses/partners who are of childbearing potential, and not using a barrier method of contraception during the study and for 30 days after final study drug administration. In addition, female spouses/partners of male subjects and who are of childbearing potential should also use a highly effective method of birth control during the study and for 30 days after final study drug administration. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Subject has significant post-void residual (PVR) volume (> 150 mL); Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by the cough provocation test); Subject has a neurological cause for detrusor overactivity; Subject has an indwelling catheter or practices intermittent self-catheterization; Subject has diabetic neuropathy; Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs; Subject has had previous lower urinary tract or pelvic floor surgery (except cystoscopy); Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin; Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis or Crohn's Disease, toxic megacolon, myasthenia gravis or any other condition which makes the use of anticholinergics contraindicated; Subject has clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Screening, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure and stroke; Subject is receiving current non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to Screening); Subject is using medications intended to treat OAB or prohibited medications. Subject has known or suspected hypersensitivity to solifenacin succinate, mirabegron or any of their excipients; Subject has any significant neurological disease or defect affecting bladder function (e.g., neurogenic bladder, systemic or central neurological disease such as multiple sclerosis [MS] and Parkinson's disease); Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg; Exclusion Criteria at Visit 2/Placebo Run-In: Subject has evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL). The subject can be enrolled into the study after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture). However, the subject must be re screened if the initial screening visit was > 28 days; Subject has a QT interval > 450 ms or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia) or is on drug treatment known to be associated with QT prolongation; Subject has clinically significant abnormalities on the 12 lead electrocardiogram (ECG); Subject has serum creatinine > 150 µmol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal (ULN), gamma-glutamyltransferase (γ-GT) > 3x ULN, or total bilirubin > 2x ULN, as assessed in Screening samples; Exclusion Criteria at Visit 3/Baseline: Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary period; Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Physician
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Organizational Affiliation
Bristol Urological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
BY37101
City
Minsk
ZIP/Postal Code
220036
Country
Belarus
Facility Name
BY37102
City
Minsk
ZIP/Postal Code
220119
Country
Belarus
Facility Name
BY37103
City
Minsk
ZIP/Postal Code
223010
Country
Belarus
Facility Name
BY37104
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
BE32102
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
BE32104
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
BE32103
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
BE32101
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CZ42005
City
Bohumín
ZIP/Postal Code
73581
Country
Czechia
Facility Name
CZ42003
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czechia
Facility Name
CZ42011
City
Ostrava
ZIP/Postal Code
700 30
Country
Czechia
Facility Name
CZ42006
City
Plzen
ZIP/Postal Code
301 24
Country
Czechia
Facility Name
CZ42007
City
Prague 4
ZIP/Postal Code
14000
Country
Czechia
Facility Name
CZ42001
City
Prague
ZIP/Postal Code
128 51
Country
Czechia
Facility Name
CZ42009
City
Prague
ZIP/Postal Code
15006
Country
Czechia
Facility Name
CZ42010
City
Roudnice nad Labem
ZIP/Postal Code
413 01
Country
Czechia
Facility Name
CZ42012
City
Sternberk
ZIP/Postal Code
78501
Country
Czechia
Facility Name
CZ42002
City
Uherske Hradiste
ZIP/Postal Code
68608
Country
Czechia
Facility Name
DK45101
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
DK45102
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
DK45104
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Facility Name
FI35803
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
FI35804
City
Kouvola
ZIP/Postal Code
45200
Country
Finland
Facility Name
FI35801
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
FI35802
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
FR33104
City
Colmar Cedex
ZIP/Postal Code
68024
Country
France
Facility Name
FR33108
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
FR33103
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
FR33111
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
FR33112
City
Paris cedex 20
ZIP/Postal Code
75970
Country
France
Facility Name
FR33106
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
FR33110
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
DE49109
City
Bad Ems
ZIP/Postal Code
56130
Country
Germany
Facility Name
DE49103
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
DE49117
City
Hagenow
ZIP/Postal Code
19230
Country
Germany
Facility Name
DE49105
City
Hettstedt
ZIP/Postal Code
06333
Country
Germany
Facility Name
DE49108
City
Leipzig
ZIP/Postal Code
04105
Country
Germany
Facility Name
DE49110
City
Neustadt I. Sachsen
ZIP/Postal Code
01844
Country
Germany
Facility Name
DE49118
City
Reutlingen
ZIP/Postal Code
72764
Country
Germany
Facility Name
DE49101
City
Rostock
ZIP/Postal Code
18107
Country
Germany
Facility Name
DE49111
City
Sangerhausen
ZIP/Postal Code
06526
Country
Germany
Facility Name
DE49104
City
Wismar
ZIP/Postal Code
23970
Country
Germany
Facility Name
HU36108
City
Csongrád
ZIP/Postal Code
6640
Country
Hungary
Facility Name
HU36101
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
HU36106
City
Körmend
ZIP/Postal Code
9900
Country
Hungary
Facility Name
HU36110
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
HU36104
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
HU36103
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
HU36107
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
IT39103
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
IT39101
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
IT39105
City
Florence
ZIP/Postal Code
50139
Country
Italy
Facility Name
IT39102
City
Treviglio (BG)
ZIP/Postal Code
24047
Country
Italy
Facility Name
NL31104
City
Amsterdam
ZIP/Postal Code
1100 AD
Country
Netherlands
Facility Name
NL31106
City
Maastricht
Country
Netherlands
Facility Name
NL31102
City
Sneek
ZIP/Postal Code
8601 ZK
Country
Netherlands
Facility Name
NL31101
City
Winterswijk
ZIP/Postal Code
7101 BN
Country
Netherlands
Facility Name
NO47104
City
Elverum
ZIP/Postal Code
2408
Country
Norway
Facility Name
NO47102
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
PL48107
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
Facility Name
PL48103
City
Lodz
ZIP/Postal Code
90-602
Country
Poland
Facility Name
PL48108
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
PL48106
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Facility Name
PL48104
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
PL48101
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
PL48105
City
Warsaw
ZIP/Postal Code
02-929
Country
Poland
Facility Name
PL48112
City
Wiecbork
ZIP/Postal Code
89-410
Country
Poland
Facility Name
PL48111
City
Wroclaw
ZIP/Postal Code
01-432
Country
Poland
Facility Name
PT35102
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
PT35105
City
Coimbra
ZIP/Postal Code
3041-801
Country
Portugal
Facility Name
PT35104
City
Lisbon
ZIP/Postal Code
1050-199
Country
Portugal
Facility Name
PT35107
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
PT35110
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
PT35101
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
PT35106
City
Tomar
ZIP/Postal Code
2304-909
Country
Portugal
Facility Name
RO40106
City
Brasov
ZIP/Postal Code
500152
Country
Romania
Facility Name
RO40102
City
Bucharest
ZIP/Postal Code
042122
Country
Romania
Facility Name
RO40104
City
Bucharest
ZIP/Postal Code
050659
Country
Romania
Facility Name
RO40103
City
Bucharest
ZIP/Postal Code
200642
Country
Romania
Facility Name
RO40108
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
Facility Name
RO40101
City
Craiova
ZIP/Postal Code
20116
Country
Romania
Facility Name
RO40105
City
Craiova
ZIP/Postal Code
20116
Country
Romania
Facility Name
RO40107
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
RU70112
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
RU70108
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
Facility Name
RU70110
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
Facility Name
RU70102
City
Saint Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
RU70103
City
Saint Petersburg
ZIP/Postal Code
194178
Country
Russian Federation
Facility Name
RU70101
City
Saint Petersburg
ZIP/Postal Code
197136
Country
Russian Federation
Facility Name
RU70107
City
Saint Petersburg
ZIP/Postal Code
198013
Country
Russian Federation
Facility Name
RU70106
City
St. Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
RU70109
City
St. Petersburg
ZIP/Postal Code
198103
Country
Russian Federation
Facility Name
RU70113
City
Ufa
ZIP/Postal Code
450096
Country
Russian Federation
Facility Name
SK42109
City
Banska Bystrica
ZIP/Postal Code
975 01
Country
Slovakia
Facility Name
SK42112
City
Bratislava
ZIP/Postal Code
832 63
Country
Slovakia
Facility Name
SK42107
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
SK42113
City
Malacky
ZIP/Postal Code
90101
Country
Slovakia
Facility Name
SK42104
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
SK42106
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
SK42105
City
Pieštany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
SK42102
City
Presov
ZIP/Postal Code
08001
Country
Slovakia
Facility Name
SK42108
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
SK42101
City
Trenčín
ZIP/Postal Code
91101
Country
Slovakia
Facility Name
SK42103
City
Zilina
Country
Slovakia
Facility Name
ES34103
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
ES34101
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
ES34109
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
ES34102
City
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
ES34105
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
ES34104
City
San Juan de Alicante
ZIP/Postal Code
03550
Country
Spain
Facility Name
ES34107
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
SE46101
City
Gothenburg
ZIP/Postal Code
41263
Country
Sweden
Facility Name
SE46103
City
Karlshamn
ZIP/Postal Code
37435
Country
Sweden
Facility Name
SE46104
City
Malmo
ZIP/Postal Code
21152
Country
Sweden
Facility Name
SE46102
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
SE46105
City
Tanumshede
ZIP/Postal Code
45781
Country
Sweden
Facility Name
UA38104
City
Dnepropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
UA38102
City
Donetsk
ZIP/Postal Code
83003
Country
Ukraine
Facility Name
UA38111
City
Donetsk
ZIP/Postal Code
83114
Country
Ukraine
Facility Name
UA38106
City
Kiev
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
UA38109
City
Kiev
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
UA38107
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
UA38101
City
Odessa
Country
Ukraine
Facility Name
UA38103
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
GB44103
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
GB44108
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
GB44106
City
Garston
ZIP/Postal Code
WD25 0EA
Country
United Kingdom
Facility Name
GB44111
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
Facility Name
GB44104
City
Nantwich
ZIP/Postal Code
CW5 5NX
Country
United Kingdom
Facility Name
GB44110
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
GB44107
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
GB44101
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
GB44105
City
Sandbach
ZIP/Postal Code
CW11 1EQ
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 study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. 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/
Citations:
PubMed Identifier
24612659
Citation
Abrams P, Kelleher C, Staskin D, Rechberger T, Kay R, Martina R, Newgreen D, Paireddy A, van Maanen R, Ridder A. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). Eur Urol. 2015 Mar;67(3):577-88. doi: 10.1016/j.eururo.2014.02.012. Epub 2014 Feb 19.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=256
Description
Link to results on the Astellas Clinical Study Results website

Learn more about this trial

A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder

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