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A Study of YM178 in Patients With Symptomatic Overactive Bladder (DRAGON)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00337090
First Posted: June 15, 2006
Last Update Posted: July 2, 2013
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.
Collaborator:
Astellas Pharma Europe B.V.
Information provided by:
Astellas Pharma Inc
  Purpose
The study will examine which dose of YM178 is best in terms of efficacy, safety and tolerability compared to placebo and compared to tolterodine, a marketed product.

Condition Intervention Phase
Overactive Bladder Drug: YM178 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Dose Ranging Study With the Beta-3 Agonist YM178 in Patients With Symptomatic Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Enrollment: 1108
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 18 years suffering from overactive bladder (OAB) for more than 3 months

Exclusion Criteria:

  • Pregnant and breastfeeding women
  • Any medical condition or need for co-medication which interferes with the drug under investigation (YM178) or the comparator (tolterodine)
  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): NCT00337090


  Show 84 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe B.V.
Investigators
Study Chair: Astellas Pharma Astellas Pharma Europe B.V.
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00337090     History of Changes
Other Study ID Numbers: 178-CL-044
First Submitted: June 14, 2006
First Posted: June 15, 2006
Last Update Posted: July 2, 2013
Last Verified: July 2013

Keywords provided by Astellas Pharma Inc:
Over Active Bladder
Urinary incontinence
YM178
Symptomatic Over Active Bladder

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