A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.
VICTOR
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
1 other identifier
interventional
398
1 country
74
Brief Summary
A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2006
Shorter than P25 for phase_4
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 1, 2006
CompletedFirst Posted
Study publicly available on registry
June 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedSeptember 18, 2014
September 1, 2014
8 months
June 1, 2006
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in micturitions per 24 hours from baseline to end of treatment
18 weeks
Secondary Outcomes (1)
Change in urgency episodes per 24 hours from baseline to end of treatment
18 weeks
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Symptoms of Overactive Bladder (OAB)
You may not qualify if:
- Current use of antimuscarinic therapy
- Evidence of a urinary tract infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
Unknown Facility
Birmingham, Alabama, 35209, United States
Unknown Facility
Phoenix, Arizona, 85050, United States
Unknown Facility
Tuscon, Arizona, 85712, United States
Unknown Facility
Atherton, California, 94027, United States
Unknown Facility
Beverly Hills, California, 90211, United States
Unknown Facility
Buena, California, 90620, United States
Unknown Facility
Buena Park, California, 90320, United States
Unknown Facility
Carmichael, California, 95608, United States
Unknown Facility
Culver City, California, 90232, United States
Unknown Facility
Fresno, California, 93720, United States
Unknown Facility
Mission Hills, California, 92084, United States
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Modesto, California, 95350, United States
Unknown Facility
Orange, California, 92869, United States
Unknown Facility
San Bernardino, California, 92404, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
Torrance, California, 90505, United States
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Aurora, Colorado, 80012, United States
Unknown Facility
Denver, Colorado, 80210, United States
Unknown Facility
Wheat Ridge, Colorado, 80033, United States
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Danbury, Connecticut, 06708, United States
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Clearwater, Florida, 33761, United States
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Daytona Beach, Florida, 32114, United States
Unknown Facility
Fort Myers, Florida, 33908, United States
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New Port Richey, Florida, 34652, United States
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Orlando, Florida, 32803, United States
Unknown Facility
Orlando, Florida, 32806, United States
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Pembroke Pines, Florida, 33027, United States
Unknown Facility
Pembroke Pines, Florida, 33028, United States
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Tallahassee, Florida, 32308, United States
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Wellington, Florida, 33414, United States
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Atlanta, Georgia, 30342, United States
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Blue Ridge, Georgia, 30513, United States
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Marietta, Georgia, 30060, United States
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Roswell, Georgia, 30076, United States
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Sandy Springs, Georgia, 30328, United States
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Snellville, Georgia, 30078, United States
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Coeur d'Alene, Idaho, 83814, United States
Unknown Facility
Evansville, Indiana, 47714, United States
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Wichita, Kansas, 67207, United States
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Shreveport, Louisiana, 71106, United States
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Boston, Massachusetts, 02115, United States
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Watertown, Massachusetts, 02472, United States
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Grand Rapids, Michigan, 49544, United States
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Jackson, Mississippi, 39202, United States
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West Orange, New Jersey, 07052, United States
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Endwell, New York, 13760, United States
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Garden City, New York, 11530, United States
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New York, New York, 10016, United States
Unknown Facility
New York, New York, 10021, United States
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Orchard Park, New York, 14127, United States
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Poughkeepsie, New York, 12601, United States
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Rochester, New York, 14642, United States
Unknown Facility
Concord, North Carolina, 28025, United States
Unknown Facility
Hickory, North Carolina, 28601, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Cincinnati, Ohio, 45212, United States
Unknown Facility
Cincinnati, Ohio, 45249, United States
Unknown Facility
Bethany, Oklahoma, 73008, United States
Unknown Facility
Norman, Oklahoma, 73071, United States
Unknown Facility
Springfield, Oregon, 97477, United States
Unknown Facility
Bala-Cynwyd, Pennsylvania, 19004, United States
Unknown Facility
Bensalem, Pennsylvania, 19020, United States
Unknown Facility
Camp Hill, Pennsylvania, 17011, United States
Unknown Facility
Lancaster, Pennsylvania, 17604, United States
Unknown Facility
Uniontown, Pennsylvania, 15401, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Simpsonville, South Carolina, 29681, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Houston, Texas, 77024, United States
Unknown Facility
Ogden, Utah, 84403, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
Virginia Beach, Virginia, 23454, United States
Unknown Facility
Mountain Lake Terrace, Washington, 98043, United States
Unknown Facility
Spokane, Washington, 99202, United States
Related Publications (1)
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.
PMID: 19837435BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Astellas US Medical Information
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2006
First Posted
June 2, 2006
Study Start
May 1, 2006
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
September 18, 2014
Record last verified: 2014-09