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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00688688
First received: May 29, 2008
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Urinary Bladder, Overactive
Drug: Mirabegron
Drug: Tolterodine
Drug: Placebo to Mirabegron
Drug: Placebo to Tolterodine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) [ 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. ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Baseline and Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 3, 6 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 3, 6 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 3, 6 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 3, 6 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline and Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Months 3, 6 and 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]

    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.



Enrollment: 2792
Study Start Date: April 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mirabegron 50 mg
Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
Drug: Mirabegron
Tablets
Other Names:
  • YM178
  • Myrbetriq
Drug: Placebo to Tolterodine
Matching tolterodine placebo capsules.
Experimental: Mirabegron 100 mg
Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
Drug: Mirabegron
Tablets
Other Names:
  • YM178
  • Myrbetriq
Drug: Placebo to Tolterodine
Matching tolterodine placebo capsules.
Active Comparator: Tolterodine ER 4 mg
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
Drug: Tolterodine
Extended release capsules
Drug: Placebo to Mirabegron
Matching mirabegron placebo tablets.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688688

  Hide Study Locations
Locations
United States, Alabama
Homewood, Alabama, United States, 35209
Huntsville, Alabama, United States, 35801
Mobile, Alabama, United States, 36608
Montgomery, Alabama, United States, 36117
United States, Alaska
Anchorage, Alaska, United States, 99508
United States, Arizona
Phoenix, Arizona, United States, 85051
Tucson, Arizona, United States, 85741
Tucson, Arizona, United States, 85712
United States, California
Atherton, California, United States, 94027
Beverly Hills, California, United States, 90211
Buena Park, California, United States, 90620
Fresno, California, United States, 93720
La Mesa, California, United States, 91942
Mission Hills, California, United States, 91345
Newport Beach, California, United States, 92660
Orange, California, United States, 92869
Sacramento, California, United States, 95831
San Bernardino, California, United States, 92404
San Diego, California, United States, 92108
San Diego, California, United States, 92120
Tarzana, California, United States, 91356
Torrance, California, United States, 90505
United States, Colorado
Aurora, Colorado, United States, 80012
Denver, Colorado, United States, 80218
Denver, Colorado, United States, 80211
Englewood, Colorado, United States, 80112
United States, Connecticut
New Britain, Connecticut, United States, 06052
Waterbury, Connecticut, United States, 06708
United States, Florida
Aventura, Florida, United States, 33180
Clearwater, Florida, United States, 33761
Clearwater, Florida, United States, 33756
Fort Meyers, Florida, United States, 33916
Miami, Florida, United States, 33136
Ocala, Florida, United States, 34471
Orlando, Florida, United States, 32803
Pembroke Pines, Florida, United States, 33027
Pembroke Pines, Florida, United States, 33024
Sarasota, Florida, United States, 34237
Tallahassee, Florida, United States, 32308
Tampa, Florida, United States, 33606
Wellington, Florida, United States, 33414
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta, Georgia, United States, 30328
Decatur, Georgia, United States, 30034
Marietta, Georgia, United States, 30060
Roswell, Georgia, United States, 30076
United States, Idaho
Coeur d'Alene, Idaho, United States, 83814
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Melrose Park, Illinois, United States, 60160
United States, Indiana
Fort Wayne, Indiana, United States, 46825
Jeffersonville, Indiana, United States, 47130
Newburgh, Indiana, United States, 47630
United States, Iowa
Des Moines, Iowa, United States, 50309
United States, Kansas
Wichita, Kansas, United States, 57207
United States, Maryland
Greenbelt, Maryland, United States, 20770
United States, Massachusetts
Watertown, Massachusetts, United States, 02472
United States, Missouri
North Kansas, Missouri, United States, 64116
United States, Montana
Billings, Montana, United States, 59102
United States, Nebraska
Lincoln, Nebraska, United States, 68516
Omaha, Nebraska, United States, 68114
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, New Jersey
New Brunswick, New Jersey, United States, 08901
West Orange, New Jersey, United States, 07052
United States, New Mexico
Albuquerque, New Mexico, United States, 87109
United States, New York
Albany, New York, United States, 12208
Albany, New York, United States, 12205
Endwell, New York, United States, 13760
Garden City, New York, United States, 11530
Kingston, New York, United States, 12401
New York, New York, United States, 10016
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Cary, North Carolina, United States, 27518
Charlotte, North Carolina, United States, 28209
Concord, North Carolina, United States, 28025
Wilmington, North Carolina, United States, 28401
Winston Salem, North Carolina, United States, 27103
United States, North Dakota
Fargo, North Dakota, United States, 58104
United States, Ohio
Cincinnati, Ohio, United States, 45212
Cleveland, Ohio, United States, 44122
Columbus, Ohio, United States, 43214
Lyndhurst, Ohio, United States, 44124
Wadsworth, Ohio, United States, 44281
United States, Oklahoma
Bethany, Oklahoma, United States, 73008
Edmond, Oklahoma, United States, 73034
Edmond, Oklahoma, United States, 73008
United States, Pennsylvania
Bala Cynwyd, Pennsylvania, United States, 19004
Jenkintown, Pennsylvania, United States, 19046
Lancaster, Pennsylvania, United States, 17604
Reading, Pennsylvania, United States, 19611
Uniontown, Pennsylvania, United States, 15401
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Greer, South Carolina, United States, 29650
Mt. Pleasant, South Carolina, United States, 29464
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Bristol, Tennessee, United States, 37620
United States, Texas
Arlington, Texas, United States, 76017
Austin, Texas, United States, 78759
Corpus Christi, Texas, United States, 78414
Dallas, Texas, United States, 75231
Houston, Texas, United States, 77024
United States, Utah
Salt Lake City, Utah, United States, 84107
United States, Virginia
Virginia Beach, Virginia, United States, 23454
United States, Washington
Mountlake Terrace, Washington, United States, 98043
Seattle, Washington, United States, 98166
Spokane, Washington, United States, 99204
Tacoma, Washington, United States, 98405
Australia
Woolloongabba, Australia
Austria
Graz, Austria, 8036
Innsbruck, Austria, 6020
Linz, Austria, 4020
Belarus
Minsk, Belarus, 223041
Minsk, Belarus, 220036
Belgium
Antwerp, Belgium, 2030
Antwerp, Belgium, 2020
Edegem, Belgium, 2650
Gent, Belgium, 9000
Kortrijk, Belgium, 8500
Leper, Belgium, 8900
Leuven, Belgium, 3000
Liege, Belgium, 4000
Sint Truiden, Belgium, 3800
Canada, Alberta
Calgary, Alberta, Canada, T2V 4R6
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Surrey, British Columbia, Canada, V3V 1N1
Victoria, British Columbia, Canada, V8T 5G1
Victoria, British Columbia, Canada, V8V 3N1
Canada, New Brunswick
Saint John, New Brunswick, Canada, E2L 3J8
Canada, Nova Scotia
Dartmouth, Nova Scotia, Canada, B2W 2S7
Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
Barrie, Ontario, Canada, L4M 7G1
Brampton, Ontario, Canada, L6T 4S5
Kitchener, Ontario, Canada, N2N 2B9
Markham, Ontario, Canada, L6B 1A1
Newmarket, Ontario, Canada, L3X 1W1
North Bay, Ontario, Canada, P1B 7K8
Oshawa, Ontario, Canada, L1H 1B9
Saint Denis, Ontario, Canada, H2X 3J4
Thunder Bay, Ontario, Canada, P7E 6E7
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Granby, Quebec, Canada, J2G 8Z9
Montreal, Quebec, Canada, H3A 1A1
Point Claire, Quebec, Canada, H9R 4S3
Canada
Montreal, Canada
Czech Republic
Brno, Czech Republic, 60200
Melnik, Czech Republic, 27601
Olomouc, Czech Republic, 77200
Ostrava-Poruba, Czech Republic, 70853
Plzen, Czech Republic, 30599
Prague, Czech Republic, 12851
Prague, Czech Republic, 18081
Prague, Czech Republic, 14056
Steti, Czech Republic, 41108
Usti nad Labem, Czech Republic, 40001
Denmark
Aalborg, Denmark, 9100
Aarhus, Denmark, 8200
Glostrup, Denmark, 2600
Roskilde, Denmark
Finland
Helsinki, Finland, 00029
Oulu, Finland, 90220
Tampere, Finland, 33521
Turku, Finland, 20100
France
Paris, Cedex 10, France, 75020
Colmar, France, 68024
Marseille Cedex 9, France, 13274
Mulhouse, France, 68070
Nimes Cedex 9, France, 30029
Orleans Cedex 2, France, 45067
Paris-Cedex12, France, 75571
Saint Priest en Jarez, France, 42055
Strasbourg, France, 67000
Toulouse Cedex 9, France, 31059
Germany
AIchach, Germany, 86551
Bad Ems, Germany, 56130
Bautzen, Germany, 02625
Berlin, Germany, 13347
Duisburg, Germany, 47051
Frankfurt, Germany, 65933
Ganderkesee, Germany, 27777
Hagenow, Germany, 19230
Halle/Saale, Germany, 06132
Hamburg, Germany, 20253
Henningsdorf, Germany, 16761
Hettstedt, Germany, 06333
Kiel, Germany
Koblenz, Germany, 56068
Leipzig, Germany, 04105
Lutherstadt Eisleben, Germany, 06295
Muenchen-Bogenhausen, Germany, 81925
Munich, Germany
Neustadt i. Sachsen, Germany, 01844
Oranienburg, Germany, 16151
Radebeul, Germany, 01445
Sangerhausen, Germany, 06526
Trier, Germany, 54290
Uetersen, Germany, 25436
Hungary
Budapest, Hungary, 1076
Budapest, Hungary, 1047
Nyiregyhaza, Hungary, 4400
Sopron, Hungary
Szeged, Hungary, 6725
Szekesfehervar, Hungary, 8000
Szekszard, Hungary, 7100
Tatabanya, Hungary, 2800
Iceland
Reykjavik, Iceland, 101
Ireland
Dublin 9, Ireland
Mullingar, Ireland
Italy
Bari, Italy, 70124
Catanzaro, Italy, 88100
Genoa, Italy, 16128
Latina, Italy, 04100
Milan, Italy, 20142
Modena, Italy, 41100
Naples, Italy, 80131
Perugia, Italy, 06122
Treviglio, Italy, 24047
Varese, Italy, 21100
Latvia
Liepaja, Latvia
Riga, Latvia
Lithuania
Kaunas, Lithuania
Netherlands
Amsterdam, Netherlands, 1105 AZ
Apeldoorn, Netherlands, 7334 DZ
Eindhoven, Netherlands, 5623 EJ
Enschede, Netherlands, 7511 JX
Leiden, Netherlands, 2334 CK
Nijmegen, Netherlands, 6532 SZ
Sneek, Netherlands, 8600 BA
Tilburg, Netherlands, 5022 GC
Winterswijk, Netherlands, 7101 BN
Norway
Bergen, Norway, 5021
Drammen, Norway, 3016
Hamar, Norway, 2317
Oslo, Norway, 0257
Tonsberg, Norway, 3103
Poland
Bialystok, Poland, 15-278
Lodz, Poland, 93-338
Lodz, Poland, 93-513
Lublin, Poland, 20-954
Warsaw, Poland, 02-005
Warsaw, Poland, 02-507
Warsaw, Poland, 00-846
Warsaw, Poland
Wroclaw, Poland, 50-556
Portugal
Amadora, Portugal, 2700
Porto, Portugal, 4099-005
Tomar, Portugal, 2304-909
Romania
Bucharest, Romania, 22328
Bucharest, Romania
Lasi, Romania
Oradea, Romania
Russian Federation
Moscow, Russian Federation, 111123
Moscow, Russian Federation, 105425
Moscow, Russian Federation, 111020
Moscow, Russian Federation, 117815
Moscow, Russian Federation, 119435
Moscow, Russian Federation, 101000
Moscow, Russian Federation, 117049
Moscow, Russian Federation, 125206
Moscow, Russian Federation, 123836
St Petersburg, Russian Federation, 197089
St. Petersburg, Russian Federation, 115516
St. Petersburg, Russian Federation, 198013
Slovakia
Martin, Slovakia, 03659
Poprad, Slovakia, 05801
Skalica, Slovakia, 90982
Trencin, Slovakia, 91101
Zilina, Slovakia, 01207
South Africa
Hatfield, South Africa
Lyttelton, South Africa
Paarl, South Africa
Pietermaritzburg, South Africa
Roodepoort, South Africa
Spain
Barcelona, Spain, 08020
Barcelona, Spain, 08036
Bilbao, Spain, 48013
Getafe, Spain, 28905
Madrid, Spain, 28016
Madrid, Spain, 28046
Mataro, Spain, 8304
Miranda de Ebro, Spain, 09200
Sevilla, Spain, 41013
Toledo, Spain, 45071
Valencia, Spain, 46010
Sweden
Huddinge, Sweden, 75185
Orebro, Sweden, 70185
Skovde, Sweden, 54130
Sonkoping, Sweden, 11883
Stockholm, Sweden, 14186
Stockholm, Sweden, 18288
Stockholm, Sweden, 17176
Umea, Sweden, 90185
Switzerland
Frauenfeld, Switzerland, 8501
Luzern, Switzerland, 6000
Ukraine
Kiev, Ukraine, 04053
Kiev, Ukraine, 01023
United Kingdom
Bristol, United Kingdom, B15 2TG
Chorley, United Kingdom, PR7 7NA
Croydon, United Kingdom, CR7 7YE
Liverpool, United Kingdom, L22 OLG
London, United Kingdom, SE5 9RS
London, United Kingdom, W2 2YP
Manchester, United Kingdom, M15 6SX
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Northwood, United Kingdom, HA6 2RN
Reading, United Kingdom, RG1 5AN
Reading, United Kingdom, RG2 7AG
Sheffield, United Kingdom, S10 2JF
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma Europe B.V.
  More Information

Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00688688     History of Changes
Other Study ID Numbers: 178-CL-049, 2007-001452-39
Study First Received: May 29, 2008
Results First Received: July 23, 2012
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belarus: Ministry of Health
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Iceland: Icelandic Medicines Control Agency
Ireland: Irish Medicines Board
Italy: Ethics Committee
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Morocco: Ministry of Public Health

Keywords provided by Astellas Pharma Inc:
Overactive Bladder
Frequency
Micturition
Urgency
Urinary incontinence
Urinary urge incontinence

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Mirabegron
Phenylpropanolamine
Tolterodine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Anti-Obesity Agents
Appetite Depressants
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 25, 2014