A Study of YM178 in Patients With Symptomatic Overactive Bladder - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 6, 2007

Last Updated Date

March 10, 2009

Start Date ^†

September 2007

Current Primary Outcome Measures ^†

Overactive bladder symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00527033 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Overactive bladder symptoms (QOL) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Study of YM178 in Patients With Symptomatic Overactive Bladder

Official Title ^†

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study in Patients With Symptomatic Overactive Bladder

Brief Summary

Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability compared to placebo

Detailed Description

To investigate the dose-response relationship of YM178 in terms of efficacy, safety and tolerability, and also the superiority of YM178 over placebo.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Urinary Bladder, Overactive

Intervention ^†

Drug: YM178
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

842

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Patients over 20 years suffering from overactive bladder

Exclusion Criteria:

Pregnant and breastfeeding women
Any clinically significant abnormal conditions which in the opinion of the investigator makes the patient unsuitable for the study

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00527033

Responsible Party

Director, Astellas Pharma, Inc.

Secondary IDs ^††

Study Sponsor ^†

Astellas Pharma Inc

Collaborators ^††

Investigators ^†

Study Chair:

Central Contact

Astellas Pharma Inc

Information Provided By

Astellas Pharma Inc

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.