At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,105 enrolled
Drug / intervention
Vibegron +1 moredrug
Likely dose
Not stated in 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.
A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
In Brief
A Phase 3 clinical trial evaluating Vibegron and Placebo for Overactive Bladder. Completed, enrolled 1,105 participants across 140 sites in 8 countries.
Detailed Summary
This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesBelgium, Canada, Hungary, Lithuania, Poland, Portugal, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartMar 2019
First PostedApr 2019
Primary CompletionJun 2023
TodayJul 2026
First PostedApr 3, 2019
Enrollment StartMar 26, 2019
Primary CompletionJun 15, 2023
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.2 years ago
Interventions
Vibegrondrug
oral administration
Placebodrug
oral administration