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

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 Frequency, Overactive Bladder, Urgency, Urinary urge incontinence, Urinary incontinence, Micturition

Eligibility Criteria

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

Inclusion Criteria:

  • Patient is willing and able to complete the micturition diary and questionnaires correctly
  • Patient has symptoms of overactive bladder for ≥ 3 months
  • Patient experiences 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 has an indwelling catheter or practices intermittent self-catheterization
  • Patient has diabetic neuropathy
  • Patient 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
  • Patient receives non-drug treatment including electro-stimulation therapy
  • Patient has severe hypertension
  • Patient 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
  • Patient has been treated with any investigational drug or device within 30 days (90 days in the UK for all clinical studies except 178-CL-046)
  • Patient had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
  • Patient has serum creatinine >150 umol/L, aspartate aminotransferase (AST) and/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

Experimental

Experimental

Active Comparator

Arm Label

Mirabegron 50 mg

Mirabegron 100 mg

Tolterodine ER 4 mg

Arm Description

Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.

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

Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.

Outcomes

Primary Outcome Measures

Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.

Secondary Outcome Measures

Change From Baseline to Months 1, 3, 6, 9, 12 and 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 prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.
Change From Baseline to Months 1, 3, 6, 9, 12 and 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 prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.
Change From Baseline to Months 1, 3, 6, 9, 12 and 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 prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The involuntary leakage of urine accompanied 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 time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from 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 delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Change From Baseline to Months 1, 3, 6, 9, 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 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 generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Change From Baseline to Months 1, 3, 6, 9, 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 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 Months 1, 3, 6, 9 and 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.
Change From Baseline to Months 1, 3, 6, 9, 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 patient 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Change From Baseline to Months 1, 3, 6, 9, 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Change From Baseline to Month 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'. A negative change from Baseline score indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Change From Baseline to Months 3, 6, 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 Months 3, 6, 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 Months 3, 6, 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 Months 3, 6, 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 and less productivity. 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 evaluating 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 evaluating 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 evaluating 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 Months 1, 3, 6, 9, 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 Months 3, 6, 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)
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.
Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram
An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event. The data reported represent the number of participants with adverse events in each category.

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
NCT00688688
Brief Title
Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Acronym
TAURUS
Official Title
A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 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 25, 2008 (Actual)
Primary Completion Date
May 6, 2010 (Actual)
Study Completion Date
May 6, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.
Detailed Description
Patients who completed 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909) or new patients could be enrolled in this study if eligible.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
Frequency, Overactive Bladder, Urgency, Urinary urge incontinence, Urinary incontinence, Micturition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2792 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirabegron 50 mg
Arm Type
Experimental
Arm Description
Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
Arm Title
Mirabegron 100 mg
Arm Type
Experimental
Arm Description
Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
Arm Title
Tolterodine ER 4 mg
Arm Type
Active Comparator
Arm Description
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
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
Extended release 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
Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.
Time Frame
From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.
Secondary Outcome Measure Information:
Title
Change From Baseline to Months 1, 3, 6, 9, 12 and 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 prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12
Title
Change From Baseline to Months 1, 3, 6, 9, 12 and 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 prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12
Title
Change From Baseline to Months 1, 3, 6, 9, 12 and 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 prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12
Title
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Description
The involuntary leakage of urine accompanied 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 time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12
Title
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
Description
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from 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 delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12
Title
Change From Baseline to Months 1, 3, 6, 9, 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 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 generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12
Title
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12
Title
Change From Baseline to Months 1, 3, 6, 9, 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12
Title
Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 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
Months 1, 3, 6, 9 and 12
Title
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 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 Months 1, 3, 6, 9 and 12
Title
Change From Baseline to Months 1, 3, 6, 9, 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 patient 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12
Title
Change From Baseline to Months 1, 3, 6, 9, 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12
Title
Change From Baseline to Month 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'. A negative change from Baseline score indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time Frame
Baseline and Month 12
Title
Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)
Description
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time Frame
Baseline and Month 12
Title
Change From Baseline to Months 3, 6, 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 Months 3, 6 and 12
Title
Change From Baseline to Months 3, 6, 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 Months 3, 6 and 12
Title
Change From Baseline to Months 3, 6, 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 Months 3, 6 and 12
Title
Change From Baseline to Months 3, 6, 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 and less productivity. A negative change from baseline indicates improvement.
Time Frame
Baseline and Months 3, 6 and 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 evaluating 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 Month 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 evaluating 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 Month 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 Month 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 evaluating 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 Month 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 Month 12
Title
Change From Baseline to Months 1, 3, 6, 9, 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 Months 1, 3, 6, 9 and 12
Title
Change From Baseline to Months 3, 6, 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 Months 3, 6 and 12
Title
Percentage of Participants With Improvement 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'. 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 Month 12
Title
Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram
Description
An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event. The data reported represent the number of participants with adverse events in each category.
Time Frame
From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.

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 for ≥ 3 months Patient experiences 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 has an indwelling catheter or practices intermittent self-catheterization Patient has diabetic neuropathy Patient 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 Patient receives non-drug treatment including electro-stimulation therapy Patient has severe hypertension Patient 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 Patient has been treated with any investigational drug or device within 30 days (90 days in the UK for all clinical studies except 178-CL-046) Patient had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period Patient has serum creatinine >150 umol/L, aspartate aminotransferase (AST) and/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
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
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85051
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
Atherton
State/Province
California
ZIP/Postal Code
94027
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
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
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
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
San Diego
State/Province
California
ZIP/Postal Code
92120
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
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
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
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
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
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
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
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
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
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
57207
Country
United States
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
City
North Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
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
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
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
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
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
43214
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
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
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
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
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76017
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
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
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
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
223041
Country
Belarus
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
City
Antwerp
ZIP/Postal Code
2030
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
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 4R6
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1N1
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3N1
Country
Canada
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 3J8
Country
Canada
City
Dartmouth
State/Province
Nova Scotia
ZIP/Postal Code
B2W 2S7
Country
Canada
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 4K9
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
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
City
Markham
State/Province
Ontario
ZIP/Postal Code
L6B 1A1
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3X 1W1
Country
Canada
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 7K8
Country
Canada
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1B9
Country
Canada
City
Saint Denis
State/Province
Ontario
ZIP/Postal Code
H2X 3J4
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
M5T 2S8
Country
Canada
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G 8Z9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Point Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
City
Montreal
Country
Canada
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
Paris
State/Province
Cedex 10
ZIP/Postal Code
75020
Country
France
City
Colmar
ZIP/Postal Code
68024
Country
France
City
Marseille Cedex 9
ZIP/Postal Code
13274
Country
France
City
Mulhouse
ZIP/Postal Code
68070
Country
France
City
Nimes Cedex 9
ZIP/Postal Code
30029
Country
France
City
Orleans Cedex 2
ZIP/Postal Code
45067
Country
France
City
Paris-Cedex12
ZIP/Postal Code
75571
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
Kiel
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
Munich
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
Budapest
ZIP/Postal Code
1047
Country
Hungary
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
4400
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
Reykjavik
ZIP/Postal Code
101
Country
Iceland
City
Dublin 9
Country
Ireland
City
Mullingar
Country
Ireland
City
Bari
ZIP/Postal Code
70124
Country
Italy
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
City
Genoa
ZIP/Postal Code
16128
Country
Italy
City
Latina
ZIP/Postal Code
04100
Country
Italy
City
Milan
ZIP/Postal Code
20142
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
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
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
City
Apeldoorn
ZIP/Postal Code
7334 DZ
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
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
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
Warsaw
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
Bucharest
ZIP/Postal Code
22328
Country
Romania
City
Bucharest
Country
Romania
City
Lasi
Country
Romania
City
Oradea
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
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
115516
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
Hatfield
Country
South Africa
City
Lyttelton
Country
South Africa
City
Paarl
Country
South Africa
City
Pietermaritzburg
Country
South Africa
City
Roodepoort
Country
South Africa
City
Barcelona
ZIP/Postal Code
08020
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Bilbao
ZIP/Postal Code
48013
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
Mataro
ZIP/Postal Code
8304
Country
Spain
City
Miranda de Ebro
ZIP/Postal Code
09200
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
Huddinge
ZIP/Postal Code
75185
Country
Sweden
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
City
Skovde
ZIP/Postal Code
54130
Country
Sweden
City
Sonkoping
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
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
Bristol
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
23195283
Citation
Chapple CR, Kaplan SA, Mitcheson D, Klecka J, Cummings J, Drogendijk T, Dorrepaal C, Martin N. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a beta(3)-adrenoceptor agonist, in overactive bladder. Eur Urol. 2013 Feb;63(2):296-305. doi: 10.1016/j.eururo.2012.10.048. Epub 2012 Nov 6.
Results Reference
background
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=25
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

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

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