Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00688688
Registration number
NCT00688688
Ethics application status
Date submitted
29/05/2008
Date registered
3/06/2008
Date last updated
11/12/2017
Titles & IDs
Public title
Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2007-001452-39
Query!
Secondary ID [2]
0
0
178-CL-049
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
TAURUS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder, Overactive
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Mirabegron
Treatment: Drugs - Tolterodine
Treatment: Drugs - Placebo to Mirabegron
Treatment: Drugs - Placebo to Tolterodine
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.
Experimental: Mirabegron 100 mg - Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
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.
Treatment: Drugs: Mirabegron
Tablets
Treatment: Drugs: Tolterodine
Extended release capsules
Treatment: Drugs: Placebo to Mirabegron
Matching mirabegron placebo tablets.
Treatment: Drugs: Placebo to Tolterodine
Matching tolterodine placebo capsules.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.
Query!
Secondary outcome [1]
0
0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [2]
0
0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline and Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [3]
0
0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline and Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [4]
0
0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline and Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [5]
0
0
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
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline and Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [6]
0
0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline and Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [7]
0
0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline and Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [8]
0
0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline and Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [9]
0
0
Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [10]
0
0
Percentage of Participants With = 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline and Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [11]
0
0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline and Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [12]
0
0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline and Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [13]
0
0
Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Baseline and Month 12
Query!
Secondary outcome [14]
0
0
Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Baseline and Month 12
Query!
Secondary outcome [15]
0
0
Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
Baseline and Months 3, 6 and 12
Query!
Secondary outcome [16]
0
0
Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
Baseline and Months 3, 6 and 12
Query!
Secondary outcome [17]
0
0
Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
Baseline and Months 3, 6 and 12
Query!
Secondary outcome [18]
0
0
Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
Baseline and Months 3, 6 and 12
Query!
Secondary outcome [19]
0
0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Query!
Assessment method [19]
0
0
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.
Query!
Timepoint [19]
0
0
Baseline and Month 12
Query!
Secondary outcome [20]
0
0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score
Query!
Assessment method [20]
0
0
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.
Query!
Timepoint [20]
0
0
Baseline and Month 12
Query!
Secondary outcome [21]
0
0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Query!
Assessment method [21]
0
0
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.
Query!
Timepoint [21]
0
0
Baseline and Month 12
Query!
Secondary outcome [22]
0
0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Query!
Assessment method [22]
0
0
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.
Query!
Timepoint [22]
0
0
Baseline and Month 12
Query!
Secondary outcome [23]
0
0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Query!
Assessment method [23]
0
0
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.
Query!
Timepoint [23]
0
0
Baseline and Month 12
Query!
Secondary outcome [24]
0
0
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)
Query!
Assessment method [24]
0
0
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.
Query!
Timepoint [24]
0
0
Baseline and Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [25]
0
0
Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician
Query!
Assessment method [25]
0
0
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.
Query!
Timepoint [25]
0
0
Baseline and Months 3, 6 and 12
Query!
Secondary outcome [26]
0
0
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC)
Query!
Assessment method [26]
0
0
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.
Query!
Timepoint [26]
0
0
Baseline and Month 12
Query!
Secondary outcome [27]
0
0
Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram
Query!
Assessment method [27]
0
0
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.
Query!
Timepoint [27]
0
0
From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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 (?-GT) > 3x ULN
- Patient has a clinically significant abnormal electrocardiogram (ECG)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/04/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
6/05/2010
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2792
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
- Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Alaska
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arizona
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Idaho
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Illinois
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Indiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Iowa
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Kansas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Missouri
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Montana
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nebraska
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Nevada
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New Jersey
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New Mexico
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New York
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
North Carolina
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
North Dakota
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Ohio
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Oklahoma
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Pennsylvania
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Rhode Island
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
South Carolina
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Tennessee
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Texas
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Utah
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Virginia
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Washington
Query!
Country [35]
0
0
Austria
Query!
State/province [35]
0
0
Graz
Query!
Country [36]
0
0
Austria
Query!
State/province [36]
0
0
Innsbruck
Query!
Country [37]
0
0
Austria
Query!
State/province [37]
0
0
Linz
Query!
Country [38]
0
0
Belarus
Query!
State/province [38]
0
0
Minsk
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Antwerp
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Edegem
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Gent
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Kortrijk
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Leper
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Leuven
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Liege
Query!
Country [46]
0
0
Belgium
Query!
State/province [46]
0
0
Sint Truiden
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Alberta
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
British Columbia
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
New Brunswick
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Nova Scotia
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Ontario
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Quebec
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Montreal
Query!
Country [54]
0
0
Czechia
Query!
State/province [54]
0
0
Brno
Query!
Country [55]
0
0
Czechia
Query!
State/province [55]
0
0
Melnik
Query!
Country [56]
0
0
Czechia
Query!
State/province [56]
0
0
Olomouc
Query!
Country [57]
0
0
Czechia
Query!
State/province [57]
0
0
Ostrava-Poruba
Query!
Country [58]
0
0
Czechia
Query!
State/province [58]
0
0
Plzen
Query!
Country [59]
0
0
Czechia
Query!
State/province [59]
0
0
Prague
Query!
Country [60]
0
0
Czechia
Query!
State/province [60]
0
0
Steti
Query!
Country [61]
0
0
Czechia
Query!
State/province [61]
0
0
Usti nad Labem
Query!
Country [62]
0
0
Denmark
Query!
State/province [62]
0
0
Aalborg
Query!
Country [63]
0
0
Denmark
Query!
State/province [63]
0
0
Aarhus
Query!
Country [64]
0
0
Denmark
Query!
State/province [64]
0
0
Glostrup
Query!
Country [65]
0
0
Denmark
Query!
State/province [65]
0
0
Roskilde
Query!
Country [66]
0
0
Finland
Query!
State/province [66]
0
0
Helsinki
Query!
Country [67]
0
0
Finland
Query!
State/province [67]
0
0
Oulu
Query!
Country [68]
0
0
Finland
Query!
State/province [68]
0
0
Tampere
Query!
Country [69]
0
0
Finland
Query!
State/province [69]
0
0
Turku
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Cedex 10
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Colmar
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Marseille Cedex 9
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Mulhouse
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Nimes Cedex 9
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Orleans Cedex 2
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Paris-Cedex12
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Saint Priest en Jarez
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Strasbourg
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Toulouse Cedex 9
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
AIchach
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Bad Ems
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Bautzen
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Berlin
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Duisburg
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Frankfurt
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Ganderkesee
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Hagenow
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Halle/Saale
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Hamburg
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Henningsdorf
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Hettstedt
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Kiel
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Koblenz
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Leipzig
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Lutherstadt Eisleben
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Muenchen-Bogenhausen
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Munich
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Neustadt I. Sachsen
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Oranienburg
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Radebeul
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Sangerhausen
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Trier
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Uetersen
Query!
Country [104]
0
0
Hungary
Query!
State/province [104]
0
0
Budapest
Query!
Country [105]
0
0
Hungary
Query!
State/province [105]
0
0
Nyiregyhaza
Query!
Country [106]
0
0
Hungary
Query!
State/province [106]
0
0
Sopron
Query!
Country [107]
0
0
Hungary
Query!
State/province [107]
0
0
Szeged
Query!
Country [108]
0
0
Hungary
Query!
State/province [108]
0
0
Szekesfehervar
Query!
Country [109]
0
0
Hungary
Query!
State/province [109]
0
0
Szekszard
Query!
Country [110]
0
0
Hungary
Query!
State/province [110]
0
0
Tatabanya
Query!
Country [111]
0
0
Iceland
Query!
State/province [111]
0
0
Reykjavik
Query!
Country [112]
0
0
Ireland
Query!
State/province [112]
0
0
Dublin 9
Query!
Country [113]
0
0
Ireland
Query!
State/province [113]
0
0
Mullingar
Query!
Country [114]
0
0
Italy
Query!
State/province [114]
0
0
Bari
Query!
Country [115]
0
0
Italy
Query!
State/province [115]
0
0
Catanzaro
Query!
Country [116]
0
0
Italy
Query!
State/province [116]
0
0
Genoa
Query!
Country [117]
0
0
Italy
Query!
State/province [117]
0
0
Latina
Query!
Country [118]
0
0
Italy
Query!
State/province [118]
0
0
Milan
Query!
Country [119]
0
0
Italy
Query!
State/province [119]
0
0
Modena
Query!
Country [120]
0
0
Italy
Query!
State/province [120]
0
0
Naples
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Perugia
Query!
Country [122]
0
0
Italy
Query!
State/province [122]
0
0
Treviglio
Query!
Country [123]
0
0
Italy
Query!
State/province [123]
0
0
Varese
Query!
Country [124]
0
0
Latvia
Query!
State/province [124]
0
0
Liepaja
Query!
Country [125]
0
0
Latvia
Query!
State/province [125]
0
0
Riga
Query!
Country [126]
0
0
Lithuania
Query!
State/province [126]
0
0
Kaunas
Query!
Country [127]
0
0
Netherlands
Query!
State/province [127]
0
0
Amsterdam
Query!
Country [128]
0
0
Netherlands
Query!
State/province [128]
0
0
Apeldoorn
Query!
Country [129]
0
0
Netherlands
Query!
State/province [129]
0
0
Eindhoven
Query!
Country [130]
0
0
Netherlands
Query!
State/province [130]
0
0
Enschede
Query!
Country [131]
0
0
Netherlands
Query!
State/province [131]
0
0
Leiden
Query!
Country [132]
0
0
Netherlands
Query!
State/province [132]
0
0
Nijmegen
Query!
Country [133]
0
0
Netherlands
Query!
State/province [133]
0
0
Sneek
Query!
Country [134]
0
0
Netherlands
Query!
State/province [134]
0
0
Tilburg
Query!
Country [135]
0
0
Netherlands
Query!
State/province [135]
0
0
Winterswijk
Query!
Country [136]
0
0
Norway
Query!
State/province [136]
0
0
Bergen
Query!
Country [137]
0
0
Norway
Query!
State/province [137]
0
0
Drammen
Query!
Country [138]
0
0
Norway
Query!
State/province [138]
0
0
Hamar
Query!
Country [139]
0
0
Norway
Query!
State/province [139]
0
0
Oslo
Query!
Country [140]
0
0
Norway
Query!
State/province [140]
0
0
Tonsberg
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Bialystok
Query!
Country [142]
0
0
Poland
Query!
State/province [142]
0
0
Lodz
Query!
Country [143]
0
0
Poland
Query!
State/province [143]
0
0
Lublin
Query!
Country [144]
0
0
Poland
Query!
State/province [144]
0
0
Warsaw
Query!
Country [145]
0
0
Poland
Query!
State/province [145]
0
0
Wroclaw
Query!
Country [146]
0
0
Portugal
Query!
State/province [146]
0
0
Amadora
Query!
Country [147]
0
0
Portugal
Query!
State/province [147]
0
0
Porto
Query!
Country [148]
0
0
Portugal
Query!
State/province [148]
0
0
Tomar
Query!
Country [149]
0
0
Romania
Query!
State/province [149]
0
0
Bucharest
Query!
Country [150]
0
0
Romania
Query!
State/province [150]
0
0
Lasi
Query!
Country [151]
0
0
Romania
Query!
State/province [151]
0
0
Oradea
Query!
Country [152]
0
0
Russian Federation
Query!
State/province [152]
0
0
Moscow
Query!
Country [153]
0
0
Russian Federation
Query!
State/province [153]
0
0
St Petersburg
Query!
Country [154]
0
0
Russian Federation
Query!
State/province [154]
0
0
St. Petersburg
Query!
Country [155]
0
0
Slovakia
Query!
State/province [155]
0
0
Martin
Query!
Country [156]
0
0
Slovakia
Query!
State/province [156]
0
0
Poprad
Query!
Country [157]
0
0
Slovakia
Query!
State/province [157]
0
0
Skalica
Query!
Country [158]
0
0
Slovakia
Query!
State/province [158]
0
0
Trencin
Query!
Country [159]
0
0
Slovakia
Query!
State/province [159]
0
0
Zilina
Query!
Country [160]
0
0
South Africa
Query!
State/province [160]
0
0
Hatfield
Query!
Country [161]
0
0
South Africa
Query!
State/province [161]
0
0
Lyttelton
Query!
Country [162]
0
0
South Africa
Query!
State/province [162]
0
0
Paarl
Query!
Country [163]
0
0
South Africa
Query!
State/province [163]
0
0
Pietermaritzburg
Query!
Country [164]
0
0
South Africa
Query!
State/province [164]
0
0
Roodepoort
Query!
Country [165]
0
0
Spain
Query!
State/province [165]
0
0
Barcelona
Query!
Country [166]
0
0
Spain
Query!
State/province [166]
0
0
Bilbao
Query!
Country [167]
0
0
Spain
Query!
State/province [167]
0
0
Getafe
Query!
Country [168]
0
0
Spain
Query!
State/province [168]
0
0
Madrid
Query!
Country [169]
0
0
Spain
Query!
State/province [169]
0
0
Mataro
Query!
Country [170]
0
0
Spain
Query!
State/province [170]
0
0
Miranda de Ebro
Query!
Country [171]
0
0
Spain
Query!
State/province [171]
0
0
Sevilla
Query!
Country [172]
0
0
Spain
Query!
State/province [172]
0
0
Toledo
Query!
Country [173]
0
0
Spain
Query!
State/province [173]
0
0
Valencia
Query!
Country [174]
0
0
Sweden
Query!
State/province [174]
0
0
Huddinge
Query!
Country [175]
0
0
Sweden
Query!
State/province [175]
0
0
Orebro
Query!
Country [176]
0
0
Sweden
Query!
State/province [176]
0
0
Skovde
Query!
Country [177]
0
0
Sweden
Query!
State/province [177]
0
0
Sonkoping
Query!
Country [178]
0
0
Sweden
Query!
State/province [178]
0
0
Stockholm
Query!
Country [179]
0
0
Sweden
Query!
State/province [179]
0
0
Umea
Query!
Country [180]
0
0
Switzerland
Query!
State/province [180]
0
0
Frauenfeld
Query!
Country [181]
0
0
Switzerland
Query!
State/province [181]
0
0
Luzern
Query!
Country [182]
0
0
Ukraine
Query!
State/province [182]
0
0
Kiev
Query!
Country [183]
0
0
United Kingdom
Query!
State/province [183]
0
0
Bristol
Query!
Country [184]
0
0
United Kingdom
Query!
State/province [184]
0
0
Chorley
Query!
Country [185]
0
0
United Kingdom
Query!
State/province [185]
0
0
Croydon
Query!
Country [186]
0
0
United Kingdom
Query!
State/province [186]
0
0
Liverpool
Query!
Country [187]
0
0
United Kingdom
Query!
State/province [187]
0
0
London
Query!
Country [188]
0
0
United Kingdom
Query!
State/province [188]
0
0
Manchester
Query!
Country [189]
0
0
United Kingdom
Query!
State/province [189]
0
0
Newcastle Upon Tyne
Query!
Country [190]
0
0
United Kingdom
Query!
State/province [190]
0
0
Northwood
Query!
Country [191]
0
0
United Kingdom
Query!
State/province [191]
0
0
Reading
Query!
Country [192]
0
0
United Kingdom
Query!
State/province [192]
0
0
Sheffield
Query!
Country [193]
0
0
United Kingdom
Query!
State/province [193]
0
0
Swansea
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Astellas Pharma Inc
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00688688
Query!
Trial related presentations / publications
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Central Contact
Query!
Address
0
0
Astellas Pharma Europe B.V.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00688688
Download to PDF