The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
A Multi-Center, Open-Label Evaluation of the Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
1 other identifier
interventional
661
1 country
79
Brief Summary
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2005
79 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
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedResults Posted
Study results publicly available
April 27, 2010
CompletedApril 27, 2010
April 1, 2010
1.6 years
September 14, 2005
December 23, 2009
April 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events
All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.
9 months
Secondary Outcomes (1)
International Prostate Symptom Score (IPSS)
9 months
Study Arms (1)
Silodosin
EXPERIMENTALSilodosin 8 mg per day with food
Interventions
Eligibility Criteria
You may qualify if:
- Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010.
You may not qualify if:
- Medical conditions that would confound the efficacy evaluation.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
Unknown Facility
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Carmichael, California, United States
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Culver City, California, United States
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Fresno, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Laguna Woods, California, United States
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Long Beach, California, United States
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Newport Beach, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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Tarzana, California, United States
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Torrance, California, United States
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Aurora, Colorado, United States
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Wheat Ridge, Colorado, United States
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Waterbury, Connecticut, United States
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Aventura, Florida, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Pensacola, Florida, United States
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Plantation, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Melrose Park, Illinois, United States
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Peoria, Illinois, United States
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Evansville, Indiana, United States
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Fort Wayne, Indiana, United States
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Des Moines, Iowa, United States
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Overland Park, Kansas, United States
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Greenbelt, Maryland, United States
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Boston, Massachusetts, United States
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Saint Joseph, Michigan, United States
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Edina, Minnesota, United States
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Jackson, Mississippi, United States
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Kansas City, Missouri, United States
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Missoula, Montana, United States
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Las Vegas, Nevada, United States
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Lawrenceville, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Bay Shore, New York, United States
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Garden City, New York, United States
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Kingston, New York, United States
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Manhasset, New York, United States
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New York, New York, United States
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Poughkeepsie, New York, United States
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Staten Island, New York, United States
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Williamsville, New York, United States
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Charlotte, North Carolina, United States
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Concord, North Carolina, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Bethany, Oklahoma, United States
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Portland, Oregon, United States
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Lancaster, Pennsylvania, United States
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Providence, Rhode Island, United States
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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Lakewood, Washington, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
Related Publications (1)
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.
PMID: 19815265RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary Hoel, RPh, PhD, Executive Director of Clinical Research
- Organization
- Watson Laboratories, Inc.
Study Officials
- STUDY DIRECTOR
Lawrence Hill, Pharm D, RPh
Watson Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
September 1, 2005
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
April 27, 2010
Results First Posted
April 27, 2010
Record last verified: 2010-04