A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
NCT ID: NCT00224107
Last Updated: 2011-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
461 participants
INTERVENTIONAL
2005-05-31
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Silodosin
Silodosin 8 mg once daily with food
Silodosin
8 mg daily for 12 weeks
placebo
Matching Placebo capsule once daily with food
Placebo
1 capsule daily for 12 weeks
Interventions
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Silodosin
8 mg daily for 12 weeks
Placebo
1 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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Huntsville, Alabama, United States
Tucson, Arizona, United States
Anaheim, California, United States
Culver City, California, United States
Irvine, California, United States
La Jolla, California, United States
Long Beach, California, United States
Newport Beach, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Wheat Ridge, Colorado, United States
Waterbury, Connecticut, United States
Aventura, Florida, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Pensacola, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Des Moines, Iowa, United States
Saint Joseph, Michigan, United States
Edina, Minnesota, United States
Missoula, Montana, United States
Las Vegas, Nevada, United States
Bay Shore, New York, United States
Garden City, New York, United States
Manhasset, New York, United States
New York, New York, United States
Staten Island, New York, United States
Williamsville, New York, United States
Charlotte, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Bethany, Oklahoma, United States
Portland, Oregon, United States
Lancaster, Pennsylvania, United States
Greer, South Carolina, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Lakewood, Washington, United States
Tacoma, Washington, United States
Milwaukee, 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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SI04009
Identifier Type: -
Identifier Source: org_study_id
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