Trials / Completed
CompletedNCT02045862
A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,829 (actual)
- Sponsor
- Astellas Pharma Europe B.V. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Urinary Bladder Overactive
- Overactive Bladder
- Urgency Incontinence
- Urinary Bladder Diseases\Urologic Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Solifenacin succinate | Participants received solifenacin 5 mg orally once a day at the same time each day. |
| DRUG | Mirabegron | Participants received mirabegron 50 mg orally once a day at the same time each day. |
| DRUG | Placebo to match solifenacin | 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. |
| DRUG | Placebo to match mirabegron | 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. |
Timeline
- Start date
- 2014-03-17
- Primary completion
- 2016-09-08
- Completion
- 2016-09-08
- First posted
- 2014-01-27
- Last updated
- 2024-10-31
- Results posted
- 2018-06-06
Locations
251 sites across 32 countries: United States, Australia, 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
Source: ClinicalTrials.gov record NCT02045862. Inclusion in this directory is not an endorsement.