NCT04562090

A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Astellas Pharma China, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study followed an open-label, randomized, 12-week, prospective, interventional post-authorization design for the treatment of OAB in 249 Chinese participants. Each eligible participant took part in a 12-week treatment period. Treatments were administered once daily orally after a meal during a 12-week, open-label treatment period. Study visits took place at weeks 4, 8 and 12. For the 25 mg mirabegron group, a dose escalation to 50 mg was permitted on visit 3 and visit 4 at the investigators' discretion. 15 study sites across China enrolled participants.

Conditions

• Urge Incontinence
• Overactive Bladder (OAB)

Interventions

Type	Name	Description
DRUG	mirabegron	Mirabegron was administered as single oral dose of 25 mg or 50 mg sustained-release tablet

Timeline

• Start date: 2021-01-06
• Primary completion: 2022-03-17
• Completion: 2022-03-30
• First posted: 2020-09-24
• Last updated: 2024-11-15
• Results posted: 2023-03-29

Locations

15 sites across 1 country: China

Regulatory

• FDA-regulated drug study