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.
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.
| Condition | Urge Incontinence, Overactive Bladder, Bladder Disorders, Urinary Incontinence, bladder disorder |
|---|---|
| Treatment | mirabegron |
| Clinical Study Identifier | NCT04562090 |
| Sponsor | Astellas Pharma China, Inc. |
| Last Modified on | 28 April 2022 |
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