NCT01745094

A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients

Safety and Efficacy of Mirabegron as Add-on Therapy in Patients With Overactive Bladder Treated With Solifenacin: A Postmarketing Open-label Study in Japan

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on therapy in patients with OAB treated with solifenacin.

Detailed description

The total duration of the study was 18 weeks, comprising a 2-week screening period and a 16-week treatment period. Patients meeting the eligibility criteria for provisional enrollment received the study drug for the screening period (solifenacin) at the same dose as that before the start of the study (2.5 or 5 mg), once daily after breakfast orally for 2 weeks. After the screening period, patients meeting the eligibility criteria for formal enrollment received the study drugs for the treatment period (solifenacin 2.5 or 5 mg and mirabegron 25 mg), once daily after breakfast orally for 16 weeks. Mirabegron dose could be increased to 50 mg at week 8 visit if the patients met all of the following criteria: (1) had an inadequate response to mirabegron at the dose of 25 mg; (2) was judged by the investigator or coinvestigator to have no safety concerns; and (3) agreed to increase the dose.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	mirabegron	oral
DRUG	solifenacin	oral

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-07-23
• Completion: 2013-07-23
• First posted: 2012-12-07
• Last updated: 2018-02-28
• Results posted: 2018-02-28

Locations

5 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study