Trials / Completed
CompletedNCT03583372
An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 506 (actual)
- Sponsor
- Urovant Sciences GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vibegron | single daily dose 75 mg |
| DRUG | placebos | placebo to match vibegron (experimental drug) and tolterodine (active comparator) |
| DRUG | Tolterodine Tartrate ER | single daily dose of 4 mg |
Timeline
- Start date
- 2018-06-14
- Primary completion
- 2019-06-13
- Completion
- 2019-07-25
- First posted
- 2018-07-11
- Last updated
- 2021-03-18
- Results posted
- 2021-02-03
Locations
107 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03583372. Inclusion in this directory is not an endorsement.