At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,792 enrolled
Drug / intervention
Mirabegron +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Mirabegron, Tolterodine, and 2 other interventions for Urinary Bladder, Overactive. Completed, enrolled 2,792 participants across 308 sites in 30 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Bladder, Overactive
CountriesAustralia, Austria, Belarus, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedJun 2008
Primary CompletionMay 2010
TodayJul 2026
First PostedJun 3, 2008
Enrollment StartApr 25, 2008
Primary CompletionMay 6, 2010
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 18.1 years ago
Interventions
Mirabegrondrug
Tablets
Tolterodinedrug
Extended release capsules
Placebo to Mirabegrondrug
Matching mirabegron placebo tablets.
Placebo to Tolterodinedrug
Matching tolterodine placebo capsules.