- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00224133
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
Study Overview
Detailed Description
This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance.
All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Arizona
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Tucson, Arizona, United States
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California
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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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Colorado
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Aurora, Colorado, United States
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Wheat Ridge, Colorado, United States
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Connecticut
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Waterbury, Connecticut, United States
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Florida
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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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Georgia
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Marietta, Georgia, United States
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Illinois
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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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Indiana
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Evansville, Indiana, United States
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Fort Wayne, Indiana, United States
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Iowa
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Des Moines, Iowa, United States
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Kansas
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Overland Park, Kansas, United States
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Maryland
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Greenbelt, Maryland, United States
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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St. Joseph, Michigan, United States
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Minnesota
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Edina, Minnesota, United States
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Mississippi
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Jackson, Mississippi, United States
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Missouri
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Kansas City, Missouri, United States
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Montana
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Missoula, Montana, United States
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Nevada
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Las Vegas, Nevada, United States
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New Jersey
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Lawrenceville, New Jersey, United States
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Voorhees, New Jersey, United States
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New Mexico
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Albuquerque, New Mexico, United States
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New York
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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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North Carolina
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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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Ohio
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Cincinnati, Ohio, United States
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Oklahoma
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Bethany, Oklahoma, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Lancaster, Pennsylvania, United States
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Rhode Island
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Providence, Rhode Island, United States
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South Carolina
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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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Texas
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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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Utah
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Salt Lake City, Utah, United States
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Virginia
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Norfolk, Virginia, United States
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Washington
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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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Wisconsin
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Silodosin
Silodosin 8 mg per day with food
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8 mg daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Adverse Events
Time Frame: 9 months
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All reported adverse events were recorded.
Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.
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9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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International Prostate Symptom Score (IPSS)
Time Frame: 9 months
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The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire.
0 indicates no symptoms and 35 indicates most severe symptoms.
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9 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Lawrence Hill, Pharm D, RPh, Watson Pharmaceuticals
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Prostatic Diseases
- Prostatic Hyperplasia
- Hyperplasia
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Silodosin
Other Study ID Numbers
- SI04011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Benign Prostatic Hyperplasia
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St. Joseph's Healthcare HamiltonOntario Ministry of Health and Long Term CareCompletedBenign Prostatic HyperplasiaCanada
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San Carlo di Nancy HospitalElesta S.R.L.CompletedBenign Prostatic Hyperplasia | Benign Prostatic Hypertrophy | Benign Prostatic Hypertrophy With Outflow Obstruction | Prostate HyperplasiaItaly
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Catholic University of the Sacred HeartCompletedBenign Prostatic Hyperplasia (BPH) | Benign Prostatic Enlargement (BPE)Italy
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Boston Scientific CorporationCompletedProstatic Hyperplasia | Benign Prostatic Hyperplasia | Prostatic Hyperplasia, Benign | Prostatic Hypertrophy | Prostatic Hypertrophy, Benign | Adenoma, Prostatic | Prostatic Adenoma | RezumDominican Republic, Czechia, Sweden
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Boston Scientific CorporationCompletedBenign Prostatic Hyperplasia | Prostatic Hyperplasia, Benign | Prostatic Hypertrophy | Prostatic Hypertrophy, Benign | Adenoma, Prostatic | Prostatic Adenoma | RezumDominican Republic
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IMBiotechnologies Ltd.CompletedBenign Prostatic Hyperplasia | Benign Prostatic HypertrophyCanada
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IRCCS Policlinico S. MatteoCompletedBenign Prostatic Hyperplasia | Benign Prostatic Hypertrophy With Outflow ObstructionItaly
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American Medical SystemsCompletedBenign Prostatic Hyperplasia | BPH | Benign Prostatic Hypertrophy | Prostate Disease
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Clinical Trials on Silodosin
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Taiho Oncology, Inc.Approved for marketingAdvanced CholangiocarcinomaUnited States
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JW PharmaceuticalCompletedNeurogenic Bladder | Voiding DysfunctionKorea, Republic of
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Watson PharmaceuticalsCompletedUrolithiasis | Ureteral Calculi | Kidney StonesUnited States
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Xintian PharmaceuticalRecruitingBenign Prostatic Hyperplasia With Lower Urinary Tract SymptomsChina
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Getz PharmaNot yet recruitingUreteric Stone of Lower Third of Ureter
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Kissei Pharmaceutical Co., Ltd.Completed
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Watson PharmaceuticalsCompletedProstatic Hyperplasia | NocturiaUnited States
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Albert Einstein Healthcare NetworkWithdrawn