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A Study of YM178 in Patients With Symptomatic Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00527033
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability compared to placebo

Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: YM178 Drug: Placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 842 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : September 2007
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Oral
Drug: YM178
Oral
Experimental: 2
Oral
Drug: YM178
Oral
Experimental: 3
Oral
Drug: YM178
Oral
Placebo Comparator: 4
Oral
Drug: Placebo
Oral


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00527033     History of Changes
Other Study ID Numbers: 178-CL-045
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

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

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