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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00333112
First received: June 1, 2006
Last updated: September 4, 2008
Last verified: January 2008

June 1, 2006
September 4, 2008
May 2006
January 2007   (final data collection date for primary outcome measure)
Change in micturations per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00333112 on ClinicalTrials.gov Archive Site
Change in urgency episodes per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.
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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Urinary Incontinence
  • Drug: solifenacin succinate
    Oral
    Other Names:
    • Vesicare®
    • YM905
  • Drug: tamsulosin
    oral
  • Drug: placebo
    oral
  • Experimental: 1
    Interventions:
    • Drug: solifenacin succinate
    • Drug: tamsulosin
  • Placebo Comparator: 2
    Interventions:
    • Drug: tamsulosin
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
398
January 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptoms of Overactive Bladder (OAB)

Exclusion Criteria:

  • Current use of antimuscarinic therapy
  • Evidence of a urinary tract infection
Male
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00333112
905-UC-008
Yes
Sr Manager Clinical Trial Registry, Astellas Pharm US, Inc.
Astellas Pharma Inc
Not Provided
Study Director: Astellas US Medical Information Astellas Pharma US, Inc.
Astellas Pharma Inc
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP