CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,527 enrolled
Drug / intervention
Solifenacin succinate +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.

Search/NCT01972841
NCT01972841Phase 3Completed

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

Astellas Pharma Europe B.V.·interventional·Posted Oct 31, 2013·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 3,527 participants across 435 sites in 42 countries.

Detailed Summary

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Bulgaria, Canada, China, Colombia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 31, 2013
Enrollment StartNov 5, 2013
Primary CompletionOct 22, 2015
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.7 years ago

Interventions

Solifenacin succinatedrug

Oral tablet

Mirabegrondrug

Oral tablet

Placebo to match solifenacin succinatedrug

Oral tablet

Placebo to match mirabegrondrug

Oral tablet