CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,530 enrolled
Drug / intervention
vibegron +3 moredrug
Likely dose
vibegron 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03492281
NCT03492281Phase 3Completed

An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder

Urovant Sciences GmbH·interventional·Posted Apr 10, 2018·Updated Mar 4, 2021

In Brief

A Phase 3 clinical trial evaluating vibegron, Vibegron placebo, and 2 other interventions for Overactive Bladder. Completed, enrolled 1,530 participants across 215 sites in 6 countries.

Detailed Summary

This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Hungary, Latvia, Lithuania, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 10, 2018
Enrollment StartMar 26, 2018
Primary CompletionJan 10, 2019
Study CompletionFeb 4, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.2 years ago

Interventions

vibegrondrug

single daily oral dose of vibegron 75 mg for 12 weeks

Vibegron placebodrug

placebo to match vibegron (experimental drug)

Tolterodine Tartrate ERdrug

single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks

Tolterodine placebodrug

placebo to match tolterodine (active comparator)