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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2007

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

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

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

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on November 19, 2008

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

Link to results on ClinicalStudyResults.org