Clinical trial NCT00333112: A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Keywords: Treatment Outcome
Urology
Solifenacin succinate
Urinary Incontinence
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 398
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 criteria: Inclusion Criteria:

* Symptoms of Overactive Bladder (OAB)

Exclusion Criteria:

* Current use of antimuscarinic therapy
* Evidence of a urinary tract infection

Primary outcomes:
measure: Change in micturitions per 24 hours from baseline to end of treatment
timeFrame: 18 weeks
Secondary outcomes:
measure: Change in urgency episodes per 24 hours from baseline to end of treatment
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tuscon
country: United States
state: Arizona
city: Atherton
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Buena Park
country: United States
state: California
city: Buena
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Culver City
country: United States
state: California
city: Fresno
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Modesto
country: United States
state: California
city: Orange
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Danbury
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Blue Ridge
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Sandy Springs
country: United States
state: Georgia
city: Snellville
country: United States
state: Georgia
city: Coeur d'Alene
country: United States
state: Idaho
city: Evansville
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Shreveport
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Watertown
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: West Orange
country: United States
state: New Jersey
city: Endwell
country: United States
state: New York
city: Garden City
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Concord
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Bethany
country: United States
state: Oklahoma
city: Norman
country: United States
state: Oklahoma
city: Springfield
country: United States
state: Oregon
city: Bala Cynwyd
country: United States
state: Pennsylvania
city: Bensalem
country: United States
state: Pennsylvania
city: Camp Hill
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Uniontown
country: United States
state: Pennsylvania
city: Mt. Pleasant
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Virginia Beach
country: United States
state: Virginia
city: Mountain Lake Terrace
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Astellas US Medical Information
role: STUDY_DIRECTOR
References:
citation: 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.