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A Study of YM178 in Patients With Symptomatic Overactive Bladder

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: September 6, 2007
Last updated: February 14, 2017
Last verified: February 2017
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Study in Patients With Symptomatic Overactive Bladder

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Overactive bladder symptoms [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Overactive bladder symptoms (QOL) [ Time Frame: 12 weeks ]

Enrollment: 842
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: YM178
Experimental: 2
Drug: YM178
Experimental: 3
Drug: YM178
Placebo Comparator: 4
Drug: 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.

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00527033

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc Identifier: NCT00527033     History of Changes
Other Study ID Numbers: 178-CL-045
Study First Received: September 6, 2007
Last Updated: February 14, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Details of the IPD sharing plan for this study can be found at

Keywords provided by Astellas Pharma Inc:
Urinary Bladder, Overactive

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on April 26, 2017