A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
NCT ID: NCT00224120
Last Updated: 2009-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
462 participants
INTERVENTIONAL
2005-05-31
2006-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Silodosin
Silodosin 8 mg/Day with food
Silodosin
8 mg daily for 12 weeks
Placebo
Matching placebo capsule once daily with food
Placebo
One capsule daily for 12 weeks
Interventions
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Silodosin
8 mg daily for 12 weeks
Placebo
One capsule daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Medical conditions in which it would be unsafe to use an alpha-blocker.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with this alpha-blocker.
50 Years
MALE
No
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Watson Laboratories, Inc.
Principal Investigators
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Lawrence Hill, PharmD, RPh
Role: STUDY_DIRECTOR
Watson Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Carmichael, California, United States
Fresno, California, United States
Laguna Woods, California, United States
San Bernardino, California, United States
Tarzana, California, United States
Torrance, California, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Chicago, Illinois, United States
Melrose Park, Illinois, United States
Evansville, Indiana, United States
Fort Wayne, Indiana, United States
Overland Park, Kansas, United States
Greenbelt, Maryland, United States
Boston, Massachusetts, United States
Jackson, Mississippi, United States
Kansas City, Missouri, United States
Lawrenceville, New Jersey, United States
Voorhees Township, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Garden City, New York, United States
Kingston, New York, United States
Poughkeepsie, New York, United States
Concord, North Carolina, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Providence, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Myrtle Beach, South Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Madison, Wisconsin, United States
Countries
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References
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Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009 Jun;181(6):2634-40. doi: 10.1016/j.juro.2009.02.034. Epub 2009 Apr 16.
Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha(1A)-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2013 Jan;189(1 Suppl):S122-8. doi: 10.1016/j.juro.2012.11.020.
Roehrborn CG, Kaplan SA, Lepor H, Volinn W. Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH. Prostate Cancer Prostatic Dis. 2011 Jun;14(2):143-8. doi: 10.1038/pcan.2010.46. Epub 2010 Dec 7.
Other Identifiers
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SI04010
Identifier Type: -
Identifier Source: org_study_id