Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

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. Identifier: NCT00337090
Recruitment Status : Completed
First Posted : June 15, 2006
Last Update Posted : July 2, 2013
Astellas Pharma Europe B.V.
Information provided by:
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Overactive Bladder Drug: YM178 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1108 participants
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
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT00337090

Show Show 84 study locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe B.V.
Layout table for investigator information
Study Chair: Astellas Pharma Astellas Pharma Europe B.V.

Additional Information:
Layout table for additonal information Identifier: NCT00337090    
Other Study ID Numbers: 178-CL-044
First Posted: June 15, 2006    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013
Keywords provided by Astellas Pharma Inc:
Over Active Bladder
Urinary incontinence
Symptomatic Over Active Bladder
Additional relevant MeSH terms:
Layout table for 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