A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men. - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00333112

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: 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 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

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
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Tamsulosin
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
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
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 24, 2012