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NCT04103450 · ClinicalTrials.gov registry record · Phase 3
Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
A Phase 3 study, sponsored by Urovant Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 276
- Enrollment target
NCT04103450: Completed Phase 3 study, sponsored by Urovant Sciences.
NCT04103450 is a Phase 3 study that has completed, run by Urovant Sciences. The registered enrollment target is 276 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04103450, a Phase 3 study, has completed, sponsored by Urovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 276 participants
- Enrollment target
Study Summary
This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).
Primary Outcome
Adverse events were collected in participants from time each participant provided informed consent in parent study through Follow-up Visit (approximately 5 days after the last dose of study drug) in this extension study (URO-901-3006 \[NCT03902080\]). For the 28-Week Vibegron group, AEs recorded prior to initiation of vibegron (ie, while receiving placebo in the parent study) were reported as AEs in the parent study. An SAE is defined as any untoward medical occurrence that, at any dose results
Interventions
- DRUG Vibegron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2019-09-19 |
| Est. Completion | 2022-07-29 |
| Phase | Phase 3 |
What the finished NCT04103450 record still lists
NCT04103450 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 1 intervention - of which Vibegron is the first listed.
NCT04103450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04103450 about?
NCT04103450 is a clinical study titled "Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia". This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).
What is the current status of trial NCT04103450?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2019-09-19. Estimated completion is 2022-07-29.
What interventions are being tested in trial NCT04103450?
The interventions under investigation include: Vibegron (DRUG).
Who is sponsoring clinical trial NCT04103450?
This trial is sponsored by Urovant Sciences, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04103450's enrollment target sits among peer trials
276 1202nd of 2000 higher than 795 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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