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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 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
1: Experimental	Drug: solifenacin succinate Oral Drug: tamsulosin oral
2: Placebo Comparator	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

Additional Information:

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Astellas Pharm US, Inc. ( Sr Manager Clinical Trial Registry )
Study ID Numbers:	905-UC-008
Study First Received:	June 1, 2006
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00333112 History of Changes
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:

Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Urination Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Cholinergic Agents
Pharmacologic Actions

Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Therapeutic Uses
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Tamsulosin
Urinary Incontinence
Adrenergic Antagonists

ClinicalTrials.gov processed this record on February 08, 2010