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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00527033

Purpose

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

Condition	Intervention	Phase
Urinary Bladder, Overactive	Drug: YM178 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study in Patients With Symptomatic Overactive Bladder

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	842
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527033

Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

Responsible Party:	Astellas Pharma, Inc. ( Director )
Study ID Numbers:	178-CL-045
Study First Received:	September 6, 2007
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00527033
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

YM178
Urinary Bladder, Overactive

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 14, 2009