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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)

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.
 
ClinicalTrials.gov Identifier: NCT00333112
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Drug: solifenacin succinate Drug: tamsulosin Drug: placebo Phase 4

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : May 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: solifenacin succinate
Oral
Other Names:
  • Vesicare®
  • YM905

Drug: tamsulosin
oral
Placebo Comparator: 2 Drug: tamsulosin
oral

Drug: placebo
oral


Outcome Measures
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Primary Outcome Measures :
  1. Change in micturitions per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Change in urgency episodes per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333112


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

Publications:

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00333112    
Other Study ID Numbers: 905-UC-008
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Astellas Pharma Inc:
Treatment Outcome
Urology
Solifenacin succinate
Urinary Incontinence
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Tamsulosin
Solifenacin Succinate
 Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents