Back to resultsA Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder (CAPRICORN)
Primary Purpose
Urinary Bladder, Overactive
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mirabegron
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Urgency, YM178, Urinary incontinence, Mirabegron, Micturition, Frequency, Urinary urgency incontinence, Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
- Patient is willing and able to complete the micturition diary and questionnaires correctly
- Patient has symptoms of overactive bladder (OAB) for ≥ 3 months
- Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
- Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence during the 3-day micturition diary period
Exclusion Criteria:
- Patient is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
- Patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
- Patient is using medications intended to treat OAB
- Patient has an indwelling catheter or practices intermittent self-catheterization
- Patient has diabetic neuropathy
- Patient has evidence of urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
- Patient receives non-drug treatment including electro-stimulation therapy
- Patient has severe hypertension
- Patient has participated in a clinical study within 30 days, or had participated in any previous study with mirabegron
- Patient had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
- Patient has serum creatinine of >150 μmol/L, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or gamma-glutamyl transpeptidase (γ-GT) > 3x ULN
- Patient has a clinically significant abnormal electrocardiogram (ECG)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Mirabegron 25 mg
Mirabegron 50 mg
Arm Description
Participants received matching mirabegron 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.
Outcomes
Primary Outcome Measures
Change From Baseline to End of Treatment (Final 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 patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Secondary Outcome Measures
Change From Baseline to End of Treatment (Final Visit) in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 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 patient 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 delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Episodes (Grades 3 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 patient 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 delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Level of Urgency
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8, Week 12 and Final 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 patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
The average number of times a patient records a new pad used per day during the 3-day micturition diary period.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
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 patient.
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
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 patient micturition diary.
Percentage of Responders for Mean Level of Urgency
Percentage of participants with a decrease from Baseline to Final Visit in mean level of urgency at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 0.24 for mean level of urgency. Mean level of urgency was derived from the average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale which ranged from 0 (No urgency) to 4 (Urge incontinence).
Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes
Percentage of participants with a decrease from baseline to final visit in mean number of urgency episodes (grade 3 or 4) at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 1.54 for mean number of urgency episodes (grade 3 or 4). The mean number of urgency episodes was derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale where a score 3=severe urgency and 4=urge incontinence.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
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.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit 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.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.
Change From Baseline to Final Visit 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 Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Change From Baseline to Final Visit 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 Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Change From Baseline to Final Visit 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 Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.
Change From Baseline to Final Visit 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 Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Change From Baseline to Final Visit 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 Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the 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 Week 12 and Final Visit 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'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.
Change From Baseline to Week 12 and Final Visit 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). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician
The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.
Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Clinician Global Impression Scale
The Clinician Global Impression Scale (CGI) assessed the change in the patient's bladder symptoms since the start of the study and was completed by the physician at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.
Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Patient Global Impression Scale
The patient global impression (PGI) scale assessed the change in bladder symptoms since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.
Summary of Baseline, Week 12 and Final Visit Change in Overall Condition on the Patient Global Impression Scale
The patient global impression (PGI) scale assessed the change in the patient's overall condition since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
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 one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00912964
Brief Title
A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Acronym
CAPRICORN
Official Title
A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (25 mg qd and 50 mg qd) in Subjects With Symptoms of Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 28, 2009 (Actual)
Primary Completion Date
April 27, 2010 (Actual)
Study Completion Date
April 27, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is intended to test efficacy, safety and tolerability of two doses of once daily (qd) Mirabegron against placebo to treat patients with symptoms of overactive bladder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
Urgency, YM178, Urinary incontinence, Mirabegron, Micturition, Frequency, Urinary urgency incontinence, Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2030 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
Arm Title
Mirabegron 25 mg
Arm Type
Experimental
Arm Description
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
Arm Title
Mirabegron 50 mg
Arm Type
Experimental
Arm Description
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Mirabegron
Other Intervention Name(s)
YM178, Myrebtriq
Intervention Description
Mirabegron tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching mirabegron placebo tablets.
Primary Outcome Measure Information:
Title
Change From Baseline to End of Treatment (Final 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 patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment (Final 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 times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline to End of Treatment (Final 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 patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
Description
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Week 4
Title
Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
Description
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Week 4
Title
Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency
Description
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Description
The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 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 patient 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 delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
Description
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Weeks 8 and 12
Title
Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
Description
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Weeks 8 and 12
Title
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
Description
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Description
The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Episodes (Grades 3 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 patient 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 delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Level of Urgency
Description
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Change From Baseline to Week 4, Week 8, Week 12 and Final 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 patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
Description
The average number of times a patient records a new pad used per day during the 3-day micturition diary period.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
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 patient.
Time Frame
Weeks 4, 8 and 12
Title
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
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 patient micturition diary.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Percentage of Responders for Mean Level of Urgency
Description
Percentage of participants with a decrease from Baseline to Final Visit in mean level of urgency at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 0.24 for mean level of urgency. Mean level of urgency was derived from the average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale which ranged from 0 (No urgency) to 4 (Urge incontinence).
Time Frame
Baseline and Week 12
Title
Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes
Description
Percentage of participants with a decrease from baseline to final visit in mean number of urgency episodes (grade 3 or 4) at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 1.54 for mean number of urgency episodes (grade 3 or 4). The mean number of urgency episodes was derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale where a score 3=severe urgency and 4=urge incontinence.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
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.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit 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.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
Description
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
Description
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
Description
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
Description
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Final Visit 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 Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Final Visit 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 Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Final Visit 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 Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Final Visit 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 Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Final Visit 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 Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the 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 Weeks 4, 8 and 12
Title
Change From Baseline to Week 12 and Final Visit 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'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 and Final Visit 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). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician
Description
The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Clinician Global Impression Scale
Description
The Clinician Global Impression Scale (CGI) assessed the change in the patient's bladder symptoms since the start of the study and was completed by the physician at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.
Time Frame
Baseline and Week 12
Title
Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Patient Global Impression Scale
Description
The patient global impression (PGI) scale assessed the change in bladder symptoms since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.
Time Frame
Baseline and Week 12
Title
Summary of Baseline, Week 12 and Final Visit Change in Overall Condition on the Patient Global Impression Scale
Description
The patient global impression (PGI) scale assessed the change in the patient's overall condition since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
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 one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score.
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:
Patient is willing and able to complete the micturition diary and questionnaires correctly
Patient has symptoms of overactive bladder (OAB) for ≥ 3 months
Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence during the 3-day micturition diary period
Exclusion Criteria:
Patient is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
Patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
Patient is using medications intended to treat OAB
Patient has an indwelling catheter or practices intermittent self-catheterization
Patient has diabetic neuropathy
Patient has evidence of urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
Patient receives non-drug treatment including electro-stimulation therapy
Patient has severe hypertension
Patient has participated in a clinical study within 30 days, or had participated in any previous study with mirabegron
Patient had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
Patient has serum creatinine of >150 μmol/L, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or gamma-glutamyl transpeptidase (γ-GT) > 3x ULN
Patient has a clinically significant abnormal electrocardiogram (ECG)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
City
Atherton
State/Province
California
ZIP/Postal Code
94027
Country
United States
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27509
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43220
Country
United States
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19605
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76017
Country
United States
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4Z9
Country
Canada
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 3J8
Country
Canada
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 4S5
Country
Canada
City
Brantford
State/Province
Ontario
ZIP/Postal Code
N3R 4N3
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 7K8
Country
Canada
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7E 6E7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G 8Z9
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
City
Ostrava
ZIP/Postal Code
735 81
Country
Czechia
City
Prague 4
ZIP/Postal Code
140 00
Country
Czechia
City
Prague
ZIP/Postal Code
128 51
Country
Czechia
City
Prague
ZIP/Postal Code
180 81
Country
Czechia
City
Aalborg
ZIP/Postal Code
DK-9100
Country
Denmark
City
Aarhus N
ZIP/Postal Code
DK-8200
Country
Denmark
City
Frederiksberg
ZIP/Postal Code
DK-2000
Country
Denmark
City
Holstebro
ZIP/Postal Code
DK-7500
Country
Denmark
City
Helsinki
ZIP/Postal Code
FIN-00029
Country
Finland
City
Oulu
ZIP/Postal Code
FIN-90220
Country
Finland
City
Tampere
ZIP/Postal Code
FIN-33521
Country
Finland
City
Bad Ems
ZIP/Postal Code
56130
Country
Germany
City
Frankfurt
ZIP/Postal Code
65933
Country
Germany
City
Hagenow
ZIP/Postal Code
19230
Country
Germany
City
Halle / Saale
ZIP/Postal Code
06132
Country
Germany
City
Henningsdorf
ZIP/Postal Code
16761
Country
Germany
City
Hettstedt
ZIP/Postal Code
06333
Country
Germany
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
City
Leipzig
ZIP/Postal Code
04109
Country
Germany
City
Lutherstadt Eisleben
ZIP/Postal Code
06295
Country
Germany
City
Neunkirchen
ZIP/Postal Code
66538
Country
Germany
City
Neustadt in Sachsen
ZIP/Postal Code
01844
Country
Germany
City
Radebeul
ZIP/Postal Code
01445
Country
Germany
City
Sangerhausen
ZIP/Postal Code
06526
Country
Germany
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
City
Kormend
ZIP/Postal Code
9900
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
City
Bergen
ZIP/Postal Code
NO-5053
Country
Norway
City
Hamar
ZIP/Postal Code
NO-2317
Country
Norway
City
Tonsberg
ZIP/Postal Code
NO-3116
Country
Norway
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
City
Coslada
ZIP/Postal Code
28822
Country
Spain
City
Getafe Madrid
ZIP/Postal Code
28905
Country
Spain
City
Gran Canaria
ZIP/Postal Code
38320
Country
Spain
City
Madrid
ZIP/Postal Code
28031
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Vic
ZIP/Postal Code
8500
Country
Spain
City
Gothenburg
ZIP/Postal Code
SE-40014
Country
Sweden
City
Huddinge
ZIP/Postal Code
SE-14186
Country
Sweden
City
Jonkoping
ZIP/Postal Code
SE-55466
Country
Sweden
City
Karlshamn
ZIP/Postal Code
SE-37435
Country
Sweden
City
Malmo
ZIP/Postal Code
SE-21744
Country
Sweden
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden
City
Stockholm
ZIP/Postal Code
SE-18288
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
Citations:
PubMed Identifier
24246044
Citation
Desroziers K, Aballea S, Maman K, Nazir J, Odeyemi I, Hakimi Z. Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder. Health Qual Life Outcomes. 2013 Nov 19;11:200. doi: 10.1186/1477-7525-11-200.
Results Reference
derived
PubMed Identifier
23769122
Citation
Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, Stolzel M, Martin N, Gunther A, Van Kerrebroeck P. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the beta(3) adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013 Aug;82(2):313-20. doi: 10.1016/j.urology.2013.02.077. Epub 2013 Jun 13. Erratum In: Urology. 2013 Dec;82(6):1457.
Results Reference
derived
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=26
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
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