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
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
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014