A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.

Verified by: Astellas Pharma Inc, January 2008
First Received: June 1, 2006 | Last Updated: September 4, 2008 | Phase: Phase 4 | Start Date: May 2006
Overall Status: Completed | Estimated Enrollment: 398
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A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men...

Brief Summary

Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Safety and Efficacy, Phase 4 Study of VESIcare® (Solifenacin Succinate) or Placebo in Combination With Tamsulosin HCl for the Treatment of Residual OAB Symptoms of Urgency and Frequency in Men VICTOR: VESIcare® In Combination With Tamsulosin in OAB Residual Symptoms”

A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
  • Study Primary Completion Date: January 2007

Detailed Clinical Trial Description

A 2 arm study ( 1 Active, 1 Placebo) to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men

Intervention(s) in this Clinical Trial

  • Drug: solifenacin succinate
    • Oral
  • Drug: tamsulosin
    • oral
  • Drug: placebo
    • oral

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Placebo Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in micturations per 24 hours from baseline to end of treatment
    • Time Frame: 18 weeks
      Safety Issue?: No

Secondary Measures

  • Change in urgency episodes per 24 hours from baseline to end of treatment
    • Time Frame: 18 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Symptoms of Overactive Bladder (OAB)

Exclusion Criteria:

  • Current use of antimuscarinic therapy
  • Evidence of a urinary tract infection

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

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

Astellas US Medical Information Study Director Astellas Pharma US, Inc.  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00333112

Study ID Number: 905-UC-008

ClinicalTrials.gov Identifier: NCT00333112

Health Authority: United States: Food and Drug Administration

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