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Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder (SCORPIO)

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mirabegron
Tolterodine
Placebo to Mirabegron
Placebo to Tolterodine
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Subject is willing and able to complete the micturition diary and questionnaires correctly
  • Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months
  • Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
  • Subject 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:

  • Subject 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
  • Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
  • Subject has an indwelling catheter or practices intermittent self-catheterization
  • Subject has diabetic neuropathy
  • Subject has evidence of a symptomatic 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
  • Subject receives non-drug treatment including electro-stimulation therapy
  • Subject has severe hypertension
  • Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients
  • Subject has been treated with any investigational drug or device within 30 days (90 days in the UK)
  • Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
  • Subject has serum creatinine >150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or gamma glutamyl transferase (γ-GT) > 3x ULN
  • Subject has a clinically significant abnormal electrocardiogram (ECG)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Active Comparator

Arm Label

Placebo

Mirabegron 50 mg

Mirabegron 100 mg

Tolterodine SR 4 mg

Arm Description

Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.

Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.

Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.

Participants received tolterodine SR 4 mg capsules and matching mirabegron placebo 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 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 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 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 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, Week 12 and 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 Week 4, Week 8, Week 12 and 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 4, Week 8, Week 12 and 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 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 Week 4, Week 8, Week 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 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.
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.
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 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.

Full Information

First Posted
May 29, 2008
Last Updated
November 9, 2017
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00689104
Brief Title
Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Acronym
SCORPIO
Official Title
A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron 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, 2008 (Actual)
Primary Completion Date
March 24, 2009 (Actual)
Study Completion Date
March 24, 2009 (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 Mirabegron against placebo and compare the efficacy and safety with active comparator in 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
Micturition, Urinary incontinence, Urinary urge incontinence, Overactive bladder (OAB), Urgency, YM178, Frequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
Arm Title
Mirabegron 50 mg
Arm Type
Experimental
Arm Description
Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
Arm Title
Mirabegron 100 mg
Arm Type
Experimental
Arm Description
Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
Arm Title
Tolterodine SR 4 mg
Arm Type
Active Comparator
Arm Description
Participants received tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Mirabegron
Other Intervention Name(s)
Myrbetriq, YM178
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
Tolterodine
Intervention Description
Capsules
Intervention Type
Drug
Intervention Name(s)
Placebo to Mirabegron
Intervention Description
Matching mirabegron placebo tablets.
Intervention Type
Drug
Intervention Name(s)
Placebo to Tolterodine
Intervention Description
Matching tolterodine placebo capsules.
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 (final visit)
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 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 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 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 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, Week 12 and 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 Weeks 4, 8 and 12
Title
Change From Baseline to Week 4, Week 8, Week 12 and 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 Weeks 4, 8 and 12
Title
Change From Baseline to Week 4, Week 8, Week 12 and 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 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 Week 4, Week 8, Week 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 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
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
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 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 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: Subject is willing and able to complete the micturition diary and questionnaires correctly Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period Subject 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: Subject 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 Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor Subject has an indwelling catheter or practices intermittent self-catheterization Subject has diabetic neuropathy Subject has evidence of a symptomatic 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 Subject receives non-drug treatment including electro-stimulation therapy Subject has severe hypertension Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients Subject has been treated with any investigational drug or device within 30 days (90 days in the UK) Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period Subject has serum creatinine >150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or gamma glutamyl transferase (γ-GT) > 3x ULN Subject has a clinically significant abnormal electrocardiogram (ECG)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
City
Auchenflower
Country
Australia
City
Clayton
Country
Australia
City
Kogarah
Country
Australia
City
Randwick
Country
Australia
City
Woolloongabba
Country
Australia
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Linz
ZIP/Postal Code
4020
Country
Austria
City
Minsk
ZIP/Postal Code
220036
Country
Belarus
City
Minsk
ZIP/Postal Code
220119
Country
Belarus
City
Minsk
ZIP/Postal Code
223041
Country
Belarus
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
City
Antwerp
ZIP/Postal Code
2030
Country
Belgium
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
City
Leper
ZIP/Postal Code
8900
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Sint Truiden
ZIP/Postal Code
3800
Country
Belgium
City
Pleven
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Varna
Country
Bulgaria
City
Brno
ZIP/Postal Code
60200
Country
Czechia
City
Melnik
ZIP/Postal Code
27601
Country
Czechia
City
Olomouc
ZIP/Postal Code
77200
Country
Czechia
City
Ostrava-Poruba
ZIP/Postal Code
70853
Country
Czechia
City
Plzen
ZIP/Postal Code
30599
Country
Czechia
City
Prague
ZIP/Postal Code
12851
Country
Czechia
City
Prague
ZIP/Postal Code
14056
Country
Czechia
City
Prague
ZIP/Postal Code
18081
Country
Czechia
City
Steti
ZIP/Postal Code
41108
Country
Czechia
City
Usti nad Labem
ZIP/Postal Code
40001
Country
Czechia
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
City
Roskilde
Country
Denmark
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
City
Oulu
ZIP/Postal Code
90220
Country
Finland
City
Tampere
ZIP/Postal Code
33521
Country
Finland
City
Turku
ZIP/Postal Code
20100
Country
Finland
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Colmar
ZIP/Postal Code
68024
Country
France
City
Marseille Cedex 9
ZIP/Postal Code
13274
Country
France
City
Marseille
ZIP/Postal Code
13285
Country
France
City
Mulhouse
ZIP/Postal Code
68070
Country
France
City
Nantes
ZIP/Postal Code
45035
Country
France
City
Nimes Cedex 9
ZIP/Postal Code
30029
Country
France
City
Orleans Cedex 2
ZIP/Postal Code
45067
Country
France
City
Paris-Cedex 12
ZIP/Postal Code
75571
Country
France
City
Paris
ZIP/Postal Code
75020
Country
France
City
Rouen
ZIP/Postal Code
76031
Country
France
City
Saint Priest en Jarez
ZIP/Postal Code
42055
Country
France
City
Strasbourg
ZIP/Postal Code
67000
Country
France
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
City
Aichach
ZIP/Postal Code
86551
Country
Germany
City
Bad Ems
ZIP/Postal Code
56130
Country
Germany
City
Bautzen
ZIP/Postal Code
02625
Country
Germany
City
Berlin
ZIP/Postal Code
13347
Country
Germany
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
City
Frankfurt
ZIP/Postal Code
65933
Country
Germany
City
Ganderkesee
ZIP/Postal Code
27777
Country
Germany
City
Hagenow
ZIP/Postal Code
19230
Country
Germany
City
Halle/Saale
ZIP/Postal Code
06132
Country
Germany
City
Hamburg
ZIP/Postal Code
20253
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
04105
Country
Germany
City
Lutherstadt Eisleben
ZIP/Postal Code
06295
Country
Germany
City
Muenchen-Bogenhausen
ZIP/Postal Code
81925
Country
Germany
City
Neustadt I. Sachsen
ZIP/Postal Code
01844
Country
Germany
City
Oranienburg
ZIP/Postal Code
16151
Country
Germany
City
Radebeul
ZIP/Postal Code
01445
Country
Germany
City
Sangerhausen
ZIP/Postal Code
06526
Country
Germany
City
Trier
ZIP/Postal Code
54290
Country
Germany
City
Uetersen
ZIP/Postal Code
25436
Country
Germany
City
Athens
Country
Greece
City
Nikaias-Piraeus
Country
Greece
City
Patras
Country
Greece
City
Thessaloniki
Country
Greece
City
Budapest
ZIP/Postal Code
1047
Country
Hungary
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
City
Eger
ZIP/Postal Code
3300
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
City
Papa
Country
Hungary
City
Sopron
Country
Hungary
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
City
Reykjavik
ZIP/Postal Code
101
Country
Iceland
City
Cork
Country
Ireland
City
Dublin 9
Country
Ireland
City
Dublin
Country
Ireland
City
Mullingar
Country
Ireland
City
Tralee
Country
Ireland
City
Bari
ZIP/Postal Code
70124
Country
Italy
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
City
Florence
ZIP/Postal Code
50139
Country
Italy
City
Florence
ZIP/Postal Code
59129
Country
Italy
City
Genoa
ZIP/Postal Code
16128
Country
Italy
City
Latina
ZIP/Postal Code
04100
Country
Italy
City
Magenta
ZIP/Postal Code
20013
Country
Italy
City
Milan
ZIP/Postal Code
20142
Country
Italy
City
Milan
ZIP/Postal Code
20153
Country
Italy
City
Modena
ZIP/Postal Code
41100
Country
Italy
City
Naples
ZIP/Postal Code
80131
Country
Italy
City
Perugia
ZIP/Postal Code
06122
Country
Italy
City
Teramo
ZIP/Postal Code
64100
Country
Italy
City
Treviglio
ZIP/Postal Code
24047
Country
Italy
City
Varese
ZIP/Postal Code
21100
Country
Italy
City
Liepaja
Country
Latvia
City
Riga
Country
Latvia
City
Kaunas
Country
Lithuania
City
Vilnius
Country
Lithuania
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
City
Apeldoorn
Country
Netherlands
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
City
Enschede
ZIP/Postal Code
7511 JX
Country
Netherlands
City
Leiden
ZIP/Postal Code
2334 CK
Country
Netherlands
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
City
Sneek
ZIP/Postal Code
8600 BA
Country
Netherlands
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
City
Winterswijk
ZIP/Postal Code
7101 BN
Country
Netherlands
City
Bergen
ZIP/Postal Code
5021
Country
Norway
City
Drammen
ZIP/Postal Code
3016
Country
Norway
City
Hamar
ZIP/Postal Code
2317
Country
Norway
City
Oslo
ZIP/Postal Code
0257
Country
Norway
City
Tonsberg
ZIP/Postal Code
3103
Country
Norway
City
Bialystok
ZIP/Postal Code
15-278
Country
Poland
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
City
Warsaw
ZIP/Postal Code
00-846
Country
Poland
City
Warsaw
ZIP/Postal Code
02-005
Country
Poland
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
City
Amadora
ZIP/Postal Code
2700
Country
Portugal
City
Porto
ZIP/Postal Code
4099-005
Country
Portugal
City
Tomar
ZIP/Postal Code
2304-909
Country
Portugal
City
Viana do Castelo
ZIP/Postal Code
4900-858
Country
Portugal
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
City
Bucharest
Country
Romania
City
Lasi
Country
Romania
City
Oradea
Country
Romania
City
Timisoara
Country
Romania
City
Moscow
ZIP/Postal Code
101000
Country
Russian Federation
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
City
Moscow
ZIP/Postal Code
111020
Country
Russian Federation
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117815
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123836
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125206
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
198013
Country
Russian Federation
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
City
Skalica
ZIP/Postal Code
90982
Country
Slovakia
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
City
Zilina
ZIP/Postal Code
01207
Country
Slovakia
City
Bloemfontein
Country
South Africa
City
Hatfield
Country
South Africa
City
Lyttelton
Country
South Africa
City
Paarl
Country
South Africa
City
Pietermaritzburg
Country
South Africa
City
Barcelona
ZIP/Postal Code
08020
Country
Spain
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
City
Esplugues De Llobregat-Barcelo
ZIP/Postal Code
08950
Country
Spain
City
Fuenlabrada
ZIP/Postal Code
28942
Country
Spain
City
Getafe
ZIP/Postal Code
28905
Country
Spain
City
Madrid
ZIP/Postal Code
28016
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Madrid
Country
Spain
City
Mataro
ZIP/Postal Code
8304
Country
Spain
City
Miranda de Ebro
ZIP/Postal Code
09200
Country
Spain
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Toledo
ZIP/Postal Code
45071
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Villareal
ZIP/Postal Code
12540
Country
Spain
City
Boras
ZIP/Postal Code
50182
Country
Sweden
City
Helsingborg
ZIP/Postal Code
25187
Country
Sweden
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
City
Skovde
ZIP/Postal Code
54130
Country
Sweden
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
City
Umea
ZIP/Postal Code
90185
Country
Sweden
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
City
Frauenfeld
ZIP/Postal Code
8501
Country
Switzerland
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
City
Kiev
ZIP/Postal Code
01023
Country
Ukraine
City
Kiev
ZIP/Postal Code
04053
Country
Ukraine
City
Birmingham
ZIP/Postal Code
B15 2TG
Country
United Kingdom
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
City
Croydon
ZIP/Postal Code
CR7 7YE
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L22 OLG
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
City
London
ZIP/Postal Code
W2 2YP
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
City
Reading
ZIP/Postal Code
RG2 7AG
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

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
23182126
Citation
Khullar V, Amarenco G, Angulo JC, Cambronero J, Hoye K, Milsom I, Radziszewski P, Rechberger T, Boerrigter P, Drogendijk T, Wooning M, Chapple C. Efficacy and tolerability of mirabegron, a beta(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013 Feb;63(2):283-95. doi: 10.1016/j.eururo.2012.10.016. Epub 2012 Nov 6.
Results Reference
background
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
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=35
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

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