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NCT00912964 · ClinicalTrials.gov registry record · Phase 3
A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
A Phase 3 study, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,030
- Enrollment target
NCT00912964: Completed Phase 3 study, sponsored by Astellas Pharma.
NCT00912964 is a Phase 3 study that has completed, run by Astellas Pharma. The registered enrollment target is 2,030 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (163% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00912964, a Phase 3 study, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,030 participants
- Enrollment target
Study Summary
The study is intended to test efficacy, safety and tolerability of two doses of once daily (qd) Mirabegron against placebo to treat patients with symptoms of overactive bladder.
Primary Outcome
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Interventions
- DRUG Placebo
- DRUG Mirabegron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,030 participants |
| Start Date | 2009-04-28 |
| Est. Completion | 2010-04-27 |
| Phase | Phase 3 |
What the finished NCT00912964 record still lists
NCT00912964 is an interventional study that assigns participants to a tested intervention. Its 2,030 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 (163% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00912964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00912964 about?
NCT00912964 is a clinical study titled "A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder". The study is intended to test efficacy, safety and tolerability of two doses of once daily (qd) Mirabegron against placebo to treat patients with symptoms of overactive bladder.
What is the current status of trial NCT00912964?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,030 participants. The study started on 2009-04-28. Estimated completion is 2010-04-27.
What interventions are being tested in trial NCT00912964?
The interventions under investigation include: Placebo (DRUG), Mirabegron (DRUG).
Who is sponsoring clinical trial NCT00912964?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00912964's enrollment target sits among peer trials
2,030 100th of 2000 higher than 1,901 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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