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

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...

Date First Received: June 14, 2006

Last Updated: April 15, 2008

Verified by: Astellas Pharma Inc, April 2008

Clinical Trial Phase: Phase 2 | Start Date: 

Overall Status: Completed

Estimated Enrollment: 1110

Brief Summary

Condition Keyword(s):

Intervention(s):

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2007

Intervention(s) in this Clinical Trial

  • Drug: YM178

Criteria for Participation in this Clinical Trial

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Astellas Pharma Study Chair Astellas Pharma Europe BV  

Additional Information

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00337090

Study ID Number: 178-CL-044

ClinicalTrials.gov Identifier: NCT00337090

Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

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