At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 506 enrolled
Drug / intervention
Vibegron +2 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.
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
In Brief
A Phase 3 clinical trial evaluating Vibegron, placebos, and 1 other intervention for Overactive Bladder. Completed, enrolled 506 participants across 107 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartJun 2018
First PostedJul 2018
Primary CompletionJun 2019
Study CompletionJul 2019
TodayJul 2026
First PostedJul 11, 2018
Enrollment StartJun 14, 2018
Primary CompletionJun 13, 2019
Study CompletionJul 25, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.0 years ago
Interventions
Vibegrondrug
single daily dose 75 mg
placebosdrug
placebo to match vibegron (experimental drug) and tolterodine (active comparator)
Tolterodine Tartrate ERdrug
single daily dose of 4 mg