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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Europe B.V.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00337090
First received: June 14, 2006
Last updated: July 1, 2013
Last verified: July 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00337090     History of Changes
Other Study ID Numbers: 178-CL-044
Study First Received: June 14, 2006
Last Updated: July 1, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Norway: Norwegian Medicines Agency
Russia: Pharmacological Committee, Ministry of Health

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
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014