A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients

Verified by: Astellas Pharma Inc, April 2008
First Received: August 24, 2006 | Last Updated: April 9, 2008 | Phase: Phase 3 | Start Date: September 2006
Overall Status: Completed | Estimated Enrollment: 246
  • …
  • Tell a FriendPrint

To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg,...

Brief Summary

Official Title: “A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder”

To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

  • Drug: solifenacin succinate
    • Oral
  • Drug: tolterodine
    • oral

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Change from baseline in mean number of micturitions per 24 hours
    • Time Frame: 8 Weeks
      Safety Issue?: No

Secondary Measures

  • Change from baseline in mean volume voided per micturition
    • Time Frame: 8 Weeks
      Safety Issue?: No
  • Change from baseline in mean number of incontinence episodes per 24 hours
    • Time Frame: 8 Weeks
      Safety Issue?: No
  • Change from baseline in mean urgency frequency per 24 hours
    • Time Frame: 8 Weeks
      Safety Issue?: No
  • Change from baseline in mean nocturia episodes per 24 hours
    • Time Frame: 8 Weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Patients willing and able to complete the micturition diary correctly
  • Patients experiencing frequency of micturition as verified in the diary
  • Patients experiencing significant post void residual volume
  • OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.

Exclusion Criteria:

  • Significant post void residual volume
  • Patients with indwelling catheters or practicing intermittent self- catheterization
  • Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Astellas Pharma Inc Industry

Overall Clinical Trial Officials and Contacts

Use Central Contact Principal Investigator Peking University First Hospital  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00368706

Study ID Number: 90506/CHoTD01

ClinicalTrials.gov Identifier: NCT00368706

Health Authority: China: State Food and Drug Administration

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00368706