NCT03492281

A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,530 (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 patients with OAB.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	vibegron	single daily oral dose of vibegron 75 mg for 12 weeks
DRUG	Vibegron placebo	placebo to match vibegron (experimental drug)
DRUG	Tolterodine Tartrate ER	single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks
DRUG	Tolterodine placebo	placebo to match tolterodine (active comparator)

Timeline

• Start date: 2018-03-26
• Primary completion: 2019-01-10
• Completion: 2019-02-04
• First posted: 2018-04-10
• Last updated: 2021-03-04
• Results posted: 2021-03-04

Locations

215 sites across 6 countries: United States, Canada, Hungary, Latvia, Lithuania, Poland

Regulatory

• FDA-regulated drug study