The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
NCT ID: NCT00224133
Last Updated: 2010-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
661 participants
INTERVENTIONAL
2005-09-30
2007-04-30
Brief Summary
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Detailed Description
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All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Silodosin
Silodosin 8 mg per day with food
Silodosin
8 mg daily
Interventions
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Silodosin
8 mg daily
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, Pharm D, RPh
Role: STUDY_DIRECTOR
Watson Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Huntsville, Alabama, United States
Tucson, Arizona, United States
Anaheim, California, United States
Carmichael, California, United States
Culver City, California, United States
Fresno, California, United States
Irvine, California, United States
La Jolla, California, United States
Laguna Woods, California, United States
Long Beach, California, United States
Newport Beach, California, United States
San Bernardino, California, United States
San Diego, California, United States
Tarzana, California, United States
Torrance, 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
New Port Richey, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Melrose Park, Illinois, United States
Peoria, Illinois, United States
Evansville, Indiana, United States
Fort Wayne, Indiana, United States
Des Moines, Iowa, United States
Overland Park, Kansas, United States
Greenbelt, Maryland, United States
Boston, Massachusetts, United States
Saint Joseph, Michigan, United States
Edina, Minnesota, United States
Jackson, Mississippi, United States
Kansas City, Missouri, United States
Missoula, Montana, United States
Las Vegas, Nevada, United States
Lawrenceville, New Jersey, United States
Voorhees Township, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Bay Shore, New York, United States
Garden City, New York, United States
Kingston, New York, United States
Manhasset, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Staten Island, New York, United States
Williamsville, New York, United States
Charlotte, North Carolina, United States
Concord, 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
Providence, Rhode Island, United States
Greer, South Carolina, 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
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Lakewood, Washington, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Madison, Wisconsin, 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. Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study. Urology. 2009 Dec;74(6):1318-22. doi: 10.1016/j.urology.2009.06.072. Epub 2009 Oct 7.
Related Links
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FDA approval summary and product label
Other Identifiers
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SI04011
Identifier Type: -
Identifier Source: org_study_id
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