NCT01604928

Study to Test the Efficacy and Safety of YM178 in Subjects With Symptoms of Overactive Bladder

A Randomized, Double-blind, Parallel Group, Proof of Concept Study of YM178 in Comparison With Placebo and Tolterodine in Patients With Symptomatic Overactive Bladder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is intended to test efficacy, safety and tolerability of two doses of YM178 against placebo and tolterodine to treat patients with symptoms of over active bladder.

Detailed description

This is a multinational, multicenter, double-blind, double-dummy, randomized, parallel group, placebo and active controlled phase II proof-of concept study. Patients are enrolled into a single-blind, 2-week placebo run in period after which they are randomized to 4 weeks of double-blind treatment with YM178 (low dose and high dose), placebo or tolterodine. Subsequently patients will be followed for an additional 2 weeks with single-blind placebo treatment. There are 6 visits in total: visit 1 at enrolment, visit 2 (baseline) after the 2-week placebo run-in, visits 3, 4 and 5 after 1, 2 and 4 weeks of double-blind treatment respectively, and visit 6 after a 2-week follow-up.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DRUG	YM178	Oral
DRUG	tolterodine	Oral
DRUG	Placebo	Oral

Timeline

• Start date: 2004-04-05
• Primary completion: 2005-01-25
• Completion: 2005-01-25
• First posted: 2012-05-24
• Last updated: 2024-10-31

Locations

30 sites across 6 countries: Belgium, Czechia, Germany, Spain, Sweden, United Kingdom