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NCT02216214 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
A Phase 4 study of Overactive Bladder (OAB), sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 888
- Enrollment target
- 20
- Study locations
NCT02216214: Completed Phase 4 study of Overactive Bladder (OAB), sponsored by Astellas Pharma Global Development.
NCT02216214 is a Phase 4 study of Overactive Bladder (OAB) that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 888 participants, above the 165-participant average among 7 other Overactive Bladder (OAB) trials with a reported enrollment target (438% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02216214, a Phase 4 study of Overactive Bladder (OAB), has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 888 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.
Primary Outcome
A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Mirabegron
Study Locations (20)
California
- Site US00176 - Anaheim
- Site US00048 - Beverly Hills
- Site US00142 - Beverly Hills
- Site US00150 - Hawaiian Gardens
- Site US00112 - Los Angeles
- Site US00034 - Los Angeles
- Site US00010 - Murrieta
- Site US00135 - San Diego
- Site US00139 - San Diego
- Site US00144 - Santa Maria
- Site US00083 - Stanford
Alabama
- Site US00066 - Huntsville
- Site US00148 - Mobile
Arizona
- Site US00020 - Tucson
- Site US00019 - Tucson
Arkansas
- Site US00063 - Little Rock
- Site US00081 - Little Rock
Colorado
- Site US00026 - Colorado Springs
- Site US00039 - Denver
Alaska
- Site US00009 - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 888 participants |
| Start Date | 2014-10-07 |
| Est. Completion | 2018-01-02 |
| Phase | Phase 4 |
What the finished NCT02216214 record still lists
NCT02216214 is an interventional study that assigns participants to a tested intervention. The registered 888 participants enrollment target is mid-sized for trials with a published cap, above the 165-participant average among 7 other Overactive Bladder (OAB) trials with a reported enrollment target (438% higher).
The record links to 1 condition, with Overactive Bladder (OAB) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02216214 names 20 study sites across 6 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT02216214 about?
NCT02216214 is a clinical study titled "Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)". The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.
What is the current status of trial NCT02216214?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 888 participants. The study started on 2014-10-07. Estimated completion is 2018-01-02.
What conditions does trial NCT02216214 study?
This clinical trial studies the following conditions: Overactive Bladder (OAB).
What interventions are being tested in trial NCT02216214?
The interventions under investigation include: Placebo (DRUG), Mirabegron (DRUG).
Who is sponsoring clinical trial NCT02216214?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02216214 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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