At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 276 enrolled
Drug / intervention
Vibegrondrug
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 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy 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 for Overactive Bladder. Completed, enrolled 276 participants across 35 sites in 2 countries.
Detailed Summary
This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesPoland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartSep 2019
First PostedSep 2019
Primary CompletionJul 2022
TodayJul 2026
First PostedSep 25, 2019
Enrollment StartSep 19, 2019
Primary CompletionJul 29, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.8 years ago
Interventions
Vibegrondrug
oral administration