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

This study has been completed.
Astellas Pharma Europe B.V.
Information provided by:
Astellas Pharma Inc Identifier:
First received: June 14, 2006
Last updated: July 1, 2013
Last verified: July 2013
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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
  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 identifier: NCT00337090

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

Additional Information: Identifier: NCT00337090     History of Changes
Other Study ID Numbers: 178-CL-044
Study First Received: June 14, 2006
Last Updated: July 1, 2013

Keywords provided by Astellas Pharma Inc:
Over Active Bladder
Urinary incontinence
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
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 September 21, 2017