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NCT02757768 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
A Phase 4 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 715
- Enrollment target
NCT02757768: Completed Phase 4 study, sponsored by Astellas Pharma Global Development.
NCT02757768 is a Phase 4 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 715 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02757768, a Phase 4 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 715 participants
- Enrollment target
Study Summary
The purpose of the study was to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).
Primary Outcome
Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included.
Interventions
- DRUG Placebo
- DRUG Mirabegron
- DRUG Tamsulosin Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 715 participants |
| Start Date | 2016-06-13 |
| Est. Completion | 2018-09-11 |
| Phase | Phase 4 |
What the finished NCT02757768 record still lists
NCT02757768 is an interventional study that assigns participants to a tested intervention. The registered 715 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02757768 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02757768 about?
NCT02757768 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)". The purpose of the study was to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).
What is the current status of trial NCT02757768?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 715 participants. The study started on 2016-06-13. Estimated completion is 2018-09-11.
What interventions are being tested in trial NCT02757768?
The interventions under investigation include: Placebo (DRUG), Mirabegron (DRUG), Tamsulosin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02757768?
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 NCT02757768's enrollment target sits among peer trials
715 114th of 2000 higher than 1,887 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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