Trials / Completed
CompletedNCT04103450
Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 276 (actual)
- Sponsor
- Urovant Sciences GmbH · Industry
- Sex
- Male
- Age
- 45 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vibegron | oral administration |
Timeline
- Start date
- 2019-09-19
- Primary completion
- 2022-07-29
- Completion
- 2022-07-29
- First posted
- 2019-09-25
- Last updated
- 2024-08-21
- Results posted
- 2024-08-21
Locations
35 sites across 2 countries: United States, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04103450. Inclusion in this directory is not an endorsement.