At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 249 enrolled
Drug / intervention
mirabegrondrug
Likely dose
mirabegron 25 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.
A Phase 4, Open-label, Randomized, Prospective, Interventional Post-authorization Efficacy and Safety Study of Mirabegron 50 mg and 25 mg for the Treatment of Overactive Bladder in Chinese Subjects
In Brief
A Phase 4 clinical trial evaluating mirabegron for Urge Incontinence and Overactive Bladder (OAB). Completed, enrolled 249 participants across 15 sites.
Detailed Summary
The purpose of this study was to evaluate the efficacy of mirabegron for the treatment of overactive bladder (OAB) in Chinese participants. This study also evaluated the safety of mirabegron for the treatment of OAB in Chinese participants, evaluated other efficacy variables of mirabegron for the treatment of OAB and explored different mirabegron starting doses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrge Incontinence, Overactive Bladder (OAB)
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartJan 2021
Primary CompletionMar 2022
Study CompletionMar 2022
TodayJul 2026
First PostedSep 24, 2020
Enrollment StartJan 6, 2021
Primary CompletionMar 17, 2022
Study CompletionMar 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.8 years ago
Interventions
mirabegrondrug
Mirabegron was administered as single oral dose of 25 mg or 50 mg sustained-release tablet