NCT01638000

A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,887 (actual)
• Sponsor: Astellas Pharma Europe Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

Conditions

• Urologic Diseases
• Urinary Bladder, Overactive
• Urinary Bladder Diseases

Interventions

Type	Name	Description
DRUG	Mirabegron	oral tablet
DRUG	Solifenacin succinate	oral tablet

Timeline

• Start date: 2012-06-12
• Primary completion: 2013-04-24
• Completion: 2013-04-24
• First posted: 2012-07-11
• Last updated: 2024-11-21
• Results posted: 2016-08-30

Locations

217 sites across 33 countries: Armenia, Austria, Belarus, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Italy, Kazakhstan, Latvia, Lebanon, Lithuania, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom