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 (Responsible Party):

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00333112

First received: June 1, 2006

Last updated: September 17, 2014

Last verified: September 2014

History of Changes

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:

MedlinePlus related topics: Bedwetting Urinary Incontinence

Drug Information available for: Succinic acid Tamsulosin Tamsulosin hydrochloride Solifenacin succinate

U.S. FDA Resources

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 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 (Adult, Senior)
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

Additional Information:

Link to Results on JAPIC - enter 140594 in the JapicCTI-RNo. field This link exits the ClinicalTrials.gov site

Publications:

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.


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 Urology Solifenacin succinate Urinary Incontinence

Additional relevant MeSH terms:


Urinary Incontinence Enuresis Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms 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

ClinicalTrials.gov processed this record on September 30, 2016

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