CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,174 enrolled
Drug / intervention
mirabegron 25 mg +7 moredrug
Likely dose
mirabegron 25 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/NCT01908829
NCT01908829Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects Who Have Received Solifenacin for 4 Weeks and Warrant Additional Relief for Their OAB Symptoms

Astellas Pharma Europe Ltd.·interventional·Posted Jul 26, 2013·Updated Oct 31, 2024

In Brief

A Phase 3 clinical trial evaluating mirabegron 25 mg, mirabegron 50 mg, and 6 other interventions for Urinary Bladder Diseases and 2 related conditions. Completed, enrolled 2,174 participants across 219 sites in 31 countries.

Detailed Summary

The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Bladder Diseases, Urinary Bladder Overactive, Urologic Diseases
CountriesArmenia, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Lebanon, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 26, 2013
Enrollment StartJul 10, 2013
Primary CompletionNov 24, 2014
Study CompletionNov 25, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.9 years ago

Interventions

mirabegron 25 mgdrug

Mirabegron was supplied as the marketed formulation in the 25 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.

mirabegron 50 mgdrug

Mirabegron was supplied as the marketed formulation in the 50 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.

solifenacin 5 mgdrug

Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.

solifenacin 10 mgdrug

Solifenacin was provided as the marketed formulation in the 10 mg strength. Medication was taken orally with a glass of water, with or without food.

mirabegron 25 mg matching placebodrug

Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

mirabegron 50 mg matching placebodrug

Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

solifenacin 5 mg matching placebodrug

Matching placebo of solifenacin succinate 5 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

solifenacin 10 mg matching placebodrug

Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.