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

  • STATUS
    Not Recruiting
  • participants needed
    249
  • sponsor
    Astellas Pharma China, Inc.
Updated on 6 July 2022
mirabegron
incontinence
overactive bladder

Summary

The purpose of this study is to evaluate the efficacy of mirabegron for the treatment of overactive blsdder (OAB) in Chinese participants. This study will also evaluate the safety of mirabegron for the treatment of OAB in Chinese participants, evaluate other efficacy variables of mirabegron for the treatment of OAB and explore different mirabegron starting doses.

Description

The study follows an open-label, randomized, 12-week, prospective, interventional postauthorization design for the treatment of OAB in approximately 249 Chinese participants. Each participant will take part in one 12-week treatment period. Treatments will be administered once daily orally after a meal during a 12-week, open-label treatment period. Study visits will take place at weeks 4, 8 and 12. For 25 mg mirabegron group, a dose escalation to 50 mg is permitted on visit 3 and visit 4 at investigators' discretion. Approximately 10 study sites across China are planned.

Details
Condition Urge Incontinence, Overactive Bladder, Bladder Disorders, Urinary Incontinence, bladder disorder
Treatment mirabegron
Clinical Study IdentifierNCT04562090
SponsorAstellas Pharma China, Inc.
Last Modified on6 July 2022

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