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.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: June 1, 2006
Last updated: September 17, 2014
Last verified: September 2014
A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.

Condition Intervention Phase
Urinary Incontinence
Drug: solifenacin succinate
Drug: tamsulosin
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change in micturitions per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in urgency episodes per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Enrollment: 398
Study Start Date: May 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: solifenacin succinate
Other Names:
  • Vesicare®
  • YM905
Drug: tamsulosin
Placebo Comparator: 2 Drug: tamsulosin
Drug: placebo

Detailed 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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptoms of Overactive Bladder (OAB)

Exclusion Criteria:

  • Current use of antimuscarinic therapy
  • Evidence of a urinary tract infection
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00333112

  Show 74 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Astellas US Medical Information Astellas Pharma US, Inc.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00333112     History of Changes
Other Study ID Numbers: 905-UC-008 
Study First Received: June 1, 2006
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Treatment Outcome
Solifenacin succinate
Urinary Incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Solifenacin Succinate
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Physiological Effects of Drugs
Urological Agents

ClinicalTrials.gov processed this record on May 26, 2016