NCT00688688

Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 mg qd in Subjects With Symptoms of Overactive Bladder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,792 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.

Detailed description

Patients who completed 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909) or new patients could be enrolled in this study if eligible.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DRUG	Mirabegron	Tablets
DRUG	Tolterodine	Extended release capsules
DRUG	Placebo to Mirabegron	Matching mirabegron placebo tablets.
DRUG	Placebo to Tolterodine	Matching tolterodine placebo capsules.

Timeline

• Start date: 2008-04-25
• Primary completion: 2010-05-06
• Completion: 2010-05-06
• First posted: 2008-06-03
• Last updated: 2024-11-20
• Results posted: 2012-10-19

Locations

308 sites across 30 countries: United States, Australia, Austria, Belarus, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom