Trials / Completed
CompletedNCT01340027
A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder
A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,307 (actual)
- Sponsor
- Astellas Pharma Europe B.V. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.
Conditions
- Urologic Diseases
- Urinary Bladder Diseases
- Urological Manifestations
- Signs and Symptoms
- Urinary Bladder, Overactive
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mirabegron | oral |
| DRUG | Solifenacin succinate | oral |
| DRUG | Placebo | oral |
Timeline
- Start date
- 2011-03-29
- Primary completion
- 2012-06-28
- Completion
- 2012-06-28
- First posted
- 2011-04-21
- Last updated
- 2024-10-31
- Results posted
- 2015-07-21
Locations
133 sites across 20 countries: Belarus, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, Spain, Sweden, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01340027. Inclusion in this directory is not an endorsement.