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NCT02045862 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study, sponsored by Astellas Pharma Europe B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 1,829
- Enrollment target
NCT02045862: Completed Phase 3 study, sponsored by Astellas Pharma Europe B.V..
NCT02045862 is a Phase 3 study that has completed, run by Astellas Pharma Europe B.V.. The registered enrollment target is 1,829 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (137% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02045862, a Phase 3 study, has completed, sponsored by Astellas Pharma Europe B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,829 participants
- Enrollment target
Study 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.
Primary Outcome
A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruptio
Interventions
- DRUG Mirabegron
- DRUG Solifenacin succinate
- DRUG Placebo to match solifenacin
- DRUG Placebo to match mirabegron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,829 participants |
| Start Date | 2014-03-17 |
| Est. Completion | 2016-09-08 |
| Phase | Phase 3 |
What the finished NCT02045862 record still lists
NCT02045862 is an interventional study that assigns participants to a tested intervention. Its 1,829 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (137% higher).
The record links to 0 conditions, and to 4 interventions - of which Mirabegron is the first listed.
NCT02045862 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02045862 about?
NCT02045862 is a clinical study titled "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". 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.
What is the current status of trial NCT02045862?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,829 participants. The study started on 2014-03-17. Estimated completion is 2016-09-08.
What interventions are being tested in trial NCT02045862?
The interventions under investigation include: Mirabegron (DRUG), Solifenacin succinate (DRUG), Placebo to match solifenacin (DRUG), Placebo to match mirabegron (DRUG).
Who is sponsoring clinical trial NCT02045862?
This trial is sponsored by Astellas Pharma Europe B.V., which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02045862's enrollment target sits among peer trials
1,829 117th of 2000 higher than 1,884 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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