The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months

This study has been completed.
Sponsor:
Information provided by:
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224133
First received: September 14, 2005
Last updated: April 6, 2010
Last verified: April 2010
  Purpose

A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: Silodosin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.


Secondary Outcome Measures:
  • International Prostate Symptom Score (IPSS) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 661
Study Start Date: September 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silodosin
Silodosin 8 mg per day with food
Drug: Silodosin
8 mg daily
Other Name: Rapaflo

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)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00224133

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
Huntsville, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
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
United States, Colorado
Aurora, Colorado, United States
Wheat Ridge, Colorado, United States
United States, Connecticut
Waterbury, Connecticut, United States
United States, Florida
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
United States, Georgia
Marietta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Melrose Park, Illinois, United States
Peoria, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Fort Wayne, Indiana, United States
United States, Iowa
Des Moines, Iowa, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Maryland
Greenbelt, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
St. Joseph, Michigan, United States
United States, Minnesota
Edina, Minnesota, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Missouri
Kansas City, Missouri, United States
United States, Montana
Missoula, Montana, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Lawrenceville, New Jersey, United States
Voorhees, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
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
United States, North Carolina
Charlotte, North Carolina, United States
Concord, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Oklahoma
Bethany, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Lancaster, Pennsylvania, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, South Carolina
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Myrtle Beach, South Carolina, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
United States, Washington
Lakewood, Washington, United States
Seattle, Washington, United States
Tacoma, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Lawrence Hill, Pharm D, RPh Watson Pharmaceuticals
  More Information

Additional Information:
Publications:
Responsible Party: Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00224133     History of Changes
Other Study ID Numbers: SI04011
Study First Received: September 14, 2005
Results First Received: December 23, 2009
Last Updated: April 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
benign prostatic hyperplasia, alpha blocker

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Silodosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014