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
  Purpose

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 micturations 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
Oral
Other Names:
  • Vesicare®
  • YM905
Drug: tamsulosin
oral
Placebo Comparator: 2 Drug: tamsulosin
oral
Drug: placebo
oral

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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333112

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

No publications provided

Responsible Party: Sr Manager Clinical Trial Registry, Astellas Pharm US, Inc.
ClinicalTrials.gov Identifier: NCT00333112     History of Changes
Other Study ID Numbers: 905-UC-008
Study First Received: June 1, 2006
Last Updated: September 4, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 16, 2014