At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,336 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, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron 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 2,336 participants across 218 sites in 30 countries.
Detailed Summary
The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Bladder, Overactive
CountriesAustralia, Austria, Belarus, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedJun 2008
Primary CompletionMar 2009
TodayJul 2026
First PostedJun 3, 2008
Enrollment StartApr 28, 2008
Primary CompletionMar 24, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.1 years ago
Interventions
Mirabegrondrug
Tablets
Tolterodinedrug
Capsules
Placebo to Mirabegrondrug
Matching mirabegron placebo tablets.
Placebo to Tolterodinedrug
Matching tolterodine placebo capsules.