NCT01972841

This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,527 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

Conditions

• Urinary Bladder Overactive
• Urinary Bladder Diseases\Urologic Diseases
• Overactive Bladder
• Urgency Incontinence

Interventions

Type	Name	Description
DRUG	Solifenacin succinate	Oral tablet
DRUG	Mirabegron	Oral tablet
DRUG	Placebo to match solifenacin succinate	Oral tablet
DRUG	Placebo to match mirabegron	Oral tablet

Timeline

• Start date: 2013-11-05
• Primary completion: 2015-10-22
• Completion: 2015-10-22
• First posted: 2013-10-31
• Last updated: 2024-10-31
• Results posted: 2018-06-12

Locations

435 sites across 42 countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, China, Colombia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom