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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: February 14, 2017
Last verified: February 2017
  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
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

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
Oral
Drug: YM178
Oral
Experimental: 2
Oral
Drug: YM178
Oral
Experimental: 3
Oral
Drug: YM178
Oral
Placebo Comparator: 4
Oral
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   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Study First Received: September 6, 2007
Last Updated: February 14, 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

ClinicalTrials.gov processed this record on August 22, 2017