CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,829 enrolled
Drug / intervention
Solifenacin succinate +3 moredrug
Likely dose
Solifenacin succinate 5 mgfrom 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.

Search/NCT02045862
NCT02045862Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects With Overactive Bladder

Astellas Pharma Europe B.V.·interventional·Posted Jan 27, 2014·Updated Oct 31, 2024

In Brief

A Phase 3 clinical trial evaluating Solifenacin succinate, Mirabegron, and 2 other interventions for Urinary Bladder Overactive and 3 related conditions. Completed, enrolled 1,829 participants across 251 sites in 32 countries.

Detailed Summary

The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Bladder Overactive, Overactive Bladder, Urgency Incontinence, Urinary Bladder Diseases\Urologic Diseases
CountriesAustralia, Belgium, Bulgaria, Canada, Czechia, Denmark, Estonia, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Thailand, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 27, 2014
Enrollment StartMar 17, 2014
Primary CompletionSep 8, 2016
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.4 years ago

Interventions

Solifenacin succinatedrug

Participants received solifenacin 5 mg orally once a day at the same time each day.

Mirabegrondrug

Participants received mirabegron 50 mg orally once a day at the same time each day.

Placebo to match solifenacindrug

Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

Placebo to match mirabegrondrug

Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.