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A Study of YM178 in Patients With Symptomatic Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00527033
First received: September 6, 2007
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: YM178
Oral
Experimental: 2 Drug: YM178
Oral
Experimental: 3 Drug: YM178
Oral
Placebo Comparator: 4 Drug: Placebo
Oral

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527033

Locations
Japan
Chubu, Japan
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyusyu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00527033     History of Changes
Other Study ID Numbers: 178-CL-045
Study First Received: September 6, 2007
Last Updated: December 13, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
YM178
Urinary Bladder, Overactive

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013