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NCT01908829 · ClinicalTrials.gov registry record · Phase 3
A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)
A Phase 3 study, sponsored by Astellas Pharma Europe.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,174
- Enrollment target
NCT01908829: Completed Phase 3 study, sponsored by Astellas Pharma Europe.
NCT01908829 is a Phase 3 study that has completed, run by Astellas Pharma Europe. The registered enrollment target is 2,174 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (182% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01908829, a Phase 3 study, has completed, sponsored by Astellas Pharma Europe.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,174 participants
- Enrollment target
Study 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.
Primary Outcome
The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of doubl
Interventions
- DRUG mirabegron 25 mg
- DRUG mirabegron 50 mg
- DRUG solifenacin 5 mg
- DRUG solifenacin 10 mg
- DRUG mirabegron 25 mg matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,174 participants |
| Start Date | 2013-07-10 |
| Est. Completion | 2014-11-25 |
| Phase | Phase 3 |
What the finished NCT01908829 record still lists
NCT01908829 is an interventional study that assigns participants to a tested intervention. Its 2,174 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 (182% higher).
The record links to 0 conditions, and to 5 interventions - of which mirabegron 25 mg is the first listed.
NCT01908829 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01908829 about?
NCT01908829 is a clinical study titled "A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)". 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.
What is the current status of trial NCT01908829?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,174 participants. The study started on 2013-07-10. Estimated completion is 2014-11-25.
What interventions are being tested in trial NCT01908829?
The interventions under investigation include: mirabegron 25 mg (DRUG), mirabegron 50 mg (DRUG), solifenacin 5 mg (DRUG), solifenacin 10 mg (DRUG), mirabegron 25 mg matching placebo (DRUG).
Who is sponsoring clinical trial NCT01908829?
This trial is sponsored by Astellas Pharma Europe, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01908829's enrollment target sits among peer trials
2,174 95th of 2000 higher than 1,906 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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