NCT00966004

A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder

Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,139 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.

Detailed description

This study examines the superiority of YM178 over the placebo and evaluates the safety and pharmacokinetics of YM178 in patients with overactive bladder, and to compare the efficacy and safety of YM178 over those of tolterodine, the control drug, without a non-inferiority test. The drug administration period is 14 weeks in total, consisting of 2 weeks for placebo (pre-investigation period) and 12 weeks for the investigational drug (treatment period).

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DRUG	YM178	oral
DRUG	Placebo	oral
DRUG	tolterodine	oral

Timeline

• Start date: 2009-07-24
• Primary completion: 2010-02-15
• Completion: 2010-02-15
• First posted: 2009-08-26
• Last updated: 2024-10-31

Locations

4 sites across 1 country: Japan