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NCT02138747 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)
A Phase 4 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 376
- Enrollment target
NCT02138747: Completed Phase 4 study, sponsored by Astellas Pharma Global Development.
NCT02138747 is a Phase 4 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 376 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02138747, a Phase 4 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 376 participants
- Enrollment target
Study Summary
The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the impact of treatment on micturition frequency and incontinence episodes.
Primary Outcome
The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects).
Interventions
- DRUG Mirabegron
- DRUG Tolterodine ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2014-07-24 |
| Est. Completion | 2015-11-11 |
| Phase | Phase 4 |
What the finished NCT02138747 record still lists
NCT02138747 is an interventional study that assigns participants to a tested intervention. The registered 376 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Mirabegron is the first listed.
NCT02138747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02138747 about?
NCT02138747 is a clinical study titled "A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)". The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the impact of treatment on micturition frequency and incontinence episodes.
What is the current status of trial NCT02138747?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 376 participants. The study started on 2014-07-24. Estimated completion is 2015-11-11.
What interventions are being tested in trial NCT02138747?
The interventions under investigation include: Mirabegron (DRUG), Tolterodine ER (DRUG).
Who is sponsoring clinical trial NCT02138747?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02138747's enrollment target sits among peer trials
376 222nd of 2000 higher than 1,778 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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