Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Tucson, Arizona 85741


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.


Study summary:

Patients who completed 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909) or new patients could be enrolled in this study if eligible.


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)


Study is Available At:


Original ID:

178-CL-049


NCT ID:

NCT00688688


Secondary ID:

2007-001452-39


Study Acronym:

TAURUS


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


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Astellas Pharma Inc


Oversight 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


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

2792


Enrollment Type:

Actual


Overall Contact Information

Official Name:Central Contact
Study Director
Astellas Pharma Europe B.V.

Study Dates

Start Date:April 25, 2008
Completion Date:May 6, 2010
Completion Type:Actual
Primary Completion Date:May 6, 2010
Primary Completion Type:Actual
Verification Date:November 2017
Last Changed Date:November 9, 2017
First Received Date:May 29, 2008
First Results Date:July 23, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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, u
Safety Issues:False
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 assesse
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC)
Time Frame:Baseline and Month 12
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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 'Wo
Outcome Type:Secondary Outcome
Measure:Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Time Frame:Baseline and Month 12
Safety Issues:False
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 anxiou
Outcome Type:Secondary Outcome
Measure:Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Time Frame:Baseline and Month 12
Safety Issues:False
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 pa
Outcome Type:Secondary Outcome
Measure:Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Time Frame:Baseline and Month 12
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure:Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score
Time Frame:Baseline and Month 12
Safety Issues:False
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 pr
Outcome Type:Secondary Outcome
Measure:Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Time Frame:Baseline and Month 12
Safety Issues:False
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 pr
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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 imp
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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 wh
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure:Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)
Time Frame:Baseline and Month 12
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure:Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
Time Frame:Baseline and Month 12
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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 f
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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 a
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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 baselin
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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:
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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=
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
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 Baselin
Outcome Type:Primary Outcome
Measure: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, u
Safety Issues:False
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

Study Interventions

Intervention Type:Drug
Name:Mirabegron
Description:Tablets
Arm Name:Mirabegron 50 mg
Other Name:Myrbetriq
Intervention Type:Drug
Name:Tolterodine
Description:Extended release capsules
Arm Name:Tolterodine ER 4 mg
Intervention Type:Drug
Name:Placebo to Mirabegron
Description:Matching mirabegron placebo tablets.
Arm Name:Tolterodine ER 4 mg
Intervention Type:Drug
Name:Placebo to Tolterodine
Description:Matching tolterodine placebo capsules.
Arm Name:Mirabegron 50 mg

Study Arms

Study Arm Type:Experimental
Arm Name:Mirabegron 50 mg
Description:Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
Study Arm Type:Experimental
Arm Name:Mirabegron 100 mg
Description:Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
Study Arm Type:Active Comparator
Arm Name:Tolterodine ER 4 mg
Description:Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Astellas Pharma Inc

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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 β(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.
PMID:23195283

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.