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NCT03583372 · ClinicalTrials.gov registry record · Phase 3
An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
A Phase 3 study, sponsored by Urovant Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 506
- Enrollment target
NCT03583372: Completed Phase 3 study, sponsored by Urovant Sciences.
NCT03583372 is a Phase 3 study that has completed, run by Urovant Sciences. The registered enrollment target is 506 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03583372, a Phase 3 study, has completed, sponsored by Urovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 506 participants
- Enrollment target
Study Summary
This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.
Primary Outcome
Adverse events were collected in participants with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first.
Interventions
- DRUG Vibegron
- DRUG Tolterodine Tartrate ER
- DRUG placebos
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 506 participants |
| Start Date | 2018-06-14 |
| Est. Completion | 2019-07-25 |
| Phase | Phase 3 |
What the finished NCT03583372 record still lists
NCT03583372 is an interventional study that assigns participants to a tested intervention. The registered 506 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 (34% lower).
The record links to 0 conditions, and to 3 interventions - of which Vibegron is the first listed.
NCT03583372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03583372 about?
NCT03583372 is a clinical study titled "An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).". This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.
What is the current status of trial NCT03583372?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 506 participants. The study started on 2018-06-14. Estimated completion is 2019-07-25.
What interventions are being tested in trial NCT03583372?
The interventions under investigation include: Vibegron (DRUG), Tolterodine Tartrate ER (DRUG), placebos (DRUG).
Who is sponsoring clinical trial NCT03583372?
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 NCT03583372's enrollment target sits among peer trials
506 741st of 2000 higher than 1,259 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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