At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,887 enrolled
Drug / intervention
Mirabegron +1 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 Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy
In Brief
A Phase 3 clinical trial evaluating Mirabegron and Solifenacin succinate for Urologic Diseases and 2 related conditions. Completed, enrolled 1,887 participants across 217 sites in 33 countries.
Detailed Summary
The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArmenia, Austria, Belarus, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Italy, Kazakhstan, Latvia, Lebanon, Lithuania, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
First PostedJul 2012
Primary CompletionApr 2013
TodayJul 2026
First PostedJul 11, 2012
Enrollment StartJun 12, 2012
Primary CompletionApr 24, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.0 years ago
Interventions
Mirabegrondrug
oral tablet
Solifenacin succinatedrug
oral tablet