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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:
ClinicalTrials.gov Identifier:
NCT00333112
First Posted: June 2, 2006
Last Update Posted: September 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
June 1, 2006
June 2, 2006
September 18, 2014
May 2006
January 2007   (Final data collection date for primary outcome measure)
Change in micturitions per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Double
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
Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. J Urol. 2009 Dec;182(6):2825-30. doi: 10.1016/j.juro.2009.08.023. Epub 2009 Oct 17.

*   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
Sexes Eligible for Study: Male
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00333112
905-UC-008
Yes
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Astellas US Medical Information Astellas Pharma US, Inc.
Astellas Pharma Inc
September 2014

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