Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
TAURUS
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
2 other identifiers
interventional
2,792
28 countries
303
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2008
303 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2008
CompletedFirst Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2010
CompletedResults Posted
Study results publicly available
October 19, 2012
CompletedNovember 20, 2024
October 1, 2024
2 years
May 29, 2008
July 23, 2012
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.
From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.
Secondary Outcomes (27)
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours
Baseline and Months 1, 3, 6, 9 and 12
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours
Baseline and Months 1, 3, 6, 9 and 12
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition
Baseline and Months 1, 3, 6, 9 and 12
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Baseline and Months 1, 3, 6, 9 and 12
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
Baseline and Months 1, 3, 6, 9 and 12
- +22 more secondary outcomes
Study Arms (3)
Mirabegron 50 mg
EXPERIMENTALParticipants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
Mirabegron 100 mg
EXPERIMENTALParticipants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
Tolterodine ER 4 mg
ACTIVE COMPARATORParticipants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (308)
Unknown Facility
Homewood, Alabama, 35209, United States
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Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Montgomery, Alabama, 36117, United States
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Anchorage, Alaska, 99508, United States
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Phoenix, Arizona, 85051, United States
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Tucson, Arizona, 85712, United States
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Tucson, Arizona, 85741, United States
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Atherton, California, 94027, United States
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Beverly Hills, California, 90211, United States
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Buena Park, California, 90620, United States
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Fresno, California, 93720, United States
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La Mesa, California, 91942, United States
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Mission Hills, California, 91345, United States
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Newport Beach, California, 92660, United States
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Orange, California, 92869, United States
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Sacramento, California, 95831, United States
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San Bernardino, California, 92404, United States
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San Diego, California, 92108, United States
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San Diego, California, 92120, United States
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Tarzana, California, 91356, United States
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Torrance, California, 90505, United States
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Aurora, Colorado, 80012, United States
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Denver, Colorado, 80211, United States
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Denver, Colorado, 80218, United States
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Englewood, Colorado, 80112, United States
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New Britain, Connecticut, 06052, United States
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Waterbury, Connecticut, 06708, United States
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Aventura, Florida, 33180, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33761, United States
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Fort Myers, Florida, 33916, United States
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Miami, Florida, 33136, United States
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Ocala, Florida, 34471, United States
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Orlando, Florida, 32803, United States
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Pembroke Pines, Florida, 33024, United States
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Pembroke Pines, Florida, 33027, United States
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Sarasota, Florida, 34237, United States
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Tallahassee, Florida, 32308, United States
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Tampa, Florida, 33606, United States
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Wellington, Florida, 33414, United States
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West Palm Beach, Florida, 33407, United States
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Atlanta, Georgia, 30328, United States
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Decatur, Georgia, 30034, United States
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Marietta, Georgia, 30060, United States
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Roswell, Georgia, 30076, United States
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Coeur d'Alene, Idaho, 83814, United States
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Idaho Falls, Idaho, 83404, United States
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Melrose Park, Illinois, 60160, United States
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Fort Wayne, Indiana, 46825, United States
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Jeffersonville, Indiana, 47130, United States
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Newburgh, Indiana, 47630, United States
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Des Moines, Iowa, 50309, United States
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Wichita, Kansas, 57207, United States
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Greenbelt, Maryland, 20770, United States
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Watertown, Massachusetts, 02472, United States
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North Kansas City, Missouri, 64116, United States
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Billings, Montana, 59102, United States
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Lincoln, Nebraska, 68516, United States
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Omaha, Nebraska, 68114, United States
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Las Vegas, Nevada, 89148, United States
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New Brunswick, New Jersey, 08901, United States
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West Orange, New Jersey, 07052, United States
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Albuquerque, New Mexico, 87109, United States
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Albany, New York, 12205, United States
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Albany, New York, 12208, United States
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Endwell, New York, 13760, United States
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Garden City, New York, 11530, United States
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Kingston, New York, 12401, United States
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New York, New York, 10016, United States
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Poughkeepsie, New York, 12601, United States
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Cary, North Carolina, 27518, United States
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Charlotte, North Carolina, 28209, United States
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Concord, North Carolina, 28025, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 58104, United States
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Cincinnati, Ohio, 45212, United States
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Cleveland, Ohio, 44122, United States
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Columbus, Ohio, 43214, United States
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Lyndhurst, Ohio, 44124, United States
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Wadsworth, Ohio, 44281, United States
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Bethany, Oklahoma, 73008, United States
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Edmond, Oklahoma, 73008, United States
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Edmond, Oklahoma, 73034, United States
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Bala-Cynwyd, Pennsylvania, 19004, United States
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Jenkintown, Pennsylvania, 19046, United States
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Lancaster, Pennsylvania, 17604, United States
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Reading, Pennsylvania, 19611, United States
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Uniontown, Pennsylvania, 15401, United States
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Warwick, Rhode Island, 02886, United States
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Greer, South Carolina, 29650, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Simpsonville, South Carolina, 29681, United States
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Bristol, Tennessee, 37620, United States
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Arlington, Texas, 76017, United States
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Austin, Texas, 78759, United States
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Corpus Christi, Texas, 78414, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77024, United States
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Salt Lake City, Utah, 84107, United States
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Virginia Beach, Virginia, 23454, United States
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Mountlake Terrace, Washington, 98043, United States
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Seattle, Washington, 98166, United States
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Spokane, Washington, 99204, United States
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Tacoma, Washington, 98405, United States
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Woolloongabba, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Minsk, 220036, Belarus
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Minsk, 223041, Belarus
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Antwerp, 2020, Belgium
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Antwerp, 2030, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Kortrijk, 8500, Belgium
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Leper, 8900, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Sint-Truiden, 3800, Belgium
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Calgary, Alberta, T2V 4R6, Canada
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Edmonton, Alberta, T5H 3V9, Canada
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Surrey, British Columbia, V3V 1N1, Canada
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Victoria, British Columbia, V8T 5G1, Canada
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Victoria, British Columbia, V8V 3N1, Canada
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Saint John, New Brunswick, E2L 3J8, Canada
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Dartmouth, Nova Scotia, B2W 2S7, Canada
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Kentville, Nova Scotia, B4N 4K9, Canada
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Barrie, Ontario, L4M 7G1, Canada
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Brampton, Ontario, L6T 4S5, Canada
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Kitchener, Ontario, N2N 2B9, Canada
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Markham, Ontario, L6B 1A1, Canada
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Newmarket, Ontario, L3X 1W1, Canada
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North Bay, Ontario, P1B 7K8, Canada
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Oshawa, Ontario, L1H 1B9, Canada
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Saint Denis, Ontario, H2X 3J4, Canada
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Thunder Bay, Ontario, P7E 6E7, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5T 2S8, Canada
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Granby, Quebec, J2G 8Z9, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Point Claire, Quebec, H9R 4S3, Canada
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Montreal, Canada
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Brno, 60200, Czechia
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Mělník, 27601, Czechia
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Olomouc, 77200, Czechia
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Ostrava-Poruba, 70853, Czechia
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Pilsen, 30599, Czechia
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Prague, 12851, Czechia
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Prague, 14056, Czechia
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Prague, 18081, Czechia
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Štětí, 41108, Czechia
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Ústí nad Labem, 40001, Czechia
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Aalborg, 9100, Denmark
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Aarhus, 8200, Denmark
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Glostrup Municipality, 2600, Denmark
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Roskilde, Denmark
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Helsinki, 00029, Finland
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Oulu, 90220, Finland
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Tampere, 33521, Finland
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Turku, 20100, Finland
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Paris, Cedex 10, 75020, France
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Colmar, 68024, France
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Marseille, 13274, France
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Mulhouse, 68070, France
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Nîmes, 30029, France
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Orléans, 45067, France
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Paris-Cedex12, 75571, France
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Saint-Priest-en-Jarez, 42055, France
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Strasbourg, 67000, France
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Toulouse, 31059, France
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Aichach, 86551, Germany
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Bad Ems, 56130, Germany
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Bautzen, 02625, Germany
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Berlin, 13347, Germany
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Duisburg, 47051, Germany
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Eisleben Lutherstadt, 06295, Germany
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Frankfurt, 65933, Germany
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Ganderkesee, 27777, Germany
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Hagenow, 19230, Germany
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Halle, 06132, Germany
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Hamburg, 20253, Germany
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Henningsdorf, 16761, Germany
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Hettstedt, 06333, Germany
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Kiel, Germany
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Koblenz, 56068, Germany
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Leipzig, 04105, Germany
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Muenchen-Bogenhausen, 81925, Germany
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Munich, Germany
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Neustadt in Sachsen, 01844, Germany
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Oranienburg, 16151, Germany
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Radebeul, 01445, Germany
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Sangerhausen, 06526, Germany
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Trier, 54290, Germany
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Uetersen, 25436, Germany
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Budapest, 1047, Hungary
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Budapest, 1076, Hungary
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Nyíregyháza, 4400, Hungary
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Sopron, Hungary
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Szeged, 6725, Hungary
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Szekszárd, 7100, Hungary
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Székesfehérvár, 8000, Hungary
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Tatabánya, 2800, Hungary
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Reykjavik, 101, Iceland
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Dublin, Ireland
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Mullingar, Ireland
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Bari, 70124, Italy
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Catanzaro, 88100, Italy
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Genoa, 16128, Italy
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Latina, 04100, Italy
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Milan, 20142, Italy
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Modena, 41100, Italy
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Naples, 80131, Italy
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Perugia, 06122, Italy
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Treviglio, 24047, Italy
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Varese, 21100, Italy
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Liepāja, Latvia
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Riga, Latvia
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Kaunas, Lithuania
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Amsterdam, 1105 AZ, Netherlands
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Apeldoorn, 7334 DZ, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Enschede, 7511 JX, Netherlands
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Leiden, 2334 CK, Netherlands
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Nijmegen, 6532 SZ, Netherlands
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Sneek, 8600 BA, Netherlands
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Tilburg, 5022 GC, Netherlands
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Winterswijk, 7101 BN, Netherlands
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Bergen, 5021, Norway
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Drammen, 3016, Norway
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Hamar, 2317, Norway
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Oslo, 0257, Norway
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Tønsberg, 3103, Norway
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Bialystok, 15-278, Poland
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Lodz, 93-338, Poland
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Lodz, 93-513, Poland
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Lublin, 20-954, Poland
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Warsaw, 00-846, Poland
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Warsaw, 02-005, Poland
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Warsaw, 02-507, Poland
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Warsaw, Poland
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Wroclaw, 50-556, Poland
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Amadora, 2700, Portugal
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Porto, 4099-005, Portugal
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Tomar, 2304-909, Portugal
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Bucharest, 22328, Romania
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Bucharest, Romania
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Lasi, Romania
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Oradea, Romania
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Moscow, 101000, Russia
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Moscow, 105425, Russia
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Moscow, 111020, Russia
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Moscow, 111123, Russia
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Moscow, 117049, Russia
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Moscow, 117815, Russia
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Moscow, 119435, Russia
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Moscow, 123836, Russia
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Moscow, 125206, Russia
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Saint Petersburg, 115516, Russia
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Saint Petersburg, 197089, Russia
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Saint Petersburg, 198013, Russia
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Martin, 03659, Slovakia
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Poprad, 05801, Slovakia
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Skalica, 90982, Slovakia
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Trenčín, 91101, Slovakia
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Žilina, 01207, Slovakia
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Hatfield, South Africa
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Lyttelton, South Africa
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Paarl, South Africa
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Pietermaritzburg, South Africa
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Roodepoort, South Africa
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Barcelona, 08020, Spain
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Barcelona, 08036, Spain
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Bilbao, 48013, Spain
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Getafe, 28905, Spain
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Madrid, 28016, Spain
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Madrid, 28046, Spain
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Mataró, 8304, Spain
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Miranda de Ebro, 09200, Spain
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Seville, 41013, Spain
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Toledo, 45071, Spain
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Valencia, 46010, Spain
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Huddinge, 75185, Sweden
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Örebro, 70185, Sweden
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Skövde, 54130, Sweden
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Sonkoping, 11883, Sweden
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Stockholm, 14186, Sweden
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Stockholm, 17176, Sweden
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Stockholm, 18288, Sweden
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Umeå, 90185, Sweden
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Frauenfeld, 8501, Switzerland
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Lucerne, 6000, Switzerland
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Kiev, 01023, Ukraine
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Kiev, 04053, Ukraine
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Bristol, B15 2TG, United Kingdom
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Chorley, PR7 7NA, United Kingdom
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Croydon, CR7 7YE, United Kingdom
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Liverpool, L22 OLG, United Kingdom
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London, SE5 9RS, United Kingdom
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London, W2 2YP, United Kingdom
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Manchester, M15 6SX, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Reading, RG1 5AN, United Kingdom
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Reading, RG2 7AG, United Kingdom
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Sheffield, S10 2JF, United Kingdom
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Swansea, SA6 6NL, United Kingdom
Related Publications (1)
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.
PMID: 23195283BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Medical Director, Global Medical Sciences
- Organization
- Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Europe B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 3, 2008
Study Start
April 25, 2008
Primary Completion
May 6, 2010
Study Completion
May 6, 2010
Last Updated
November 20, 2024
Results First Posted
October 19, 2012
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.