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

April 6, 2010 updated by: Watson Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

661

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Silodosin
Silodosin 8 mg per day with food
Drug: Silodosin
8 mg daily
Other Names:
  • Rapaflo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 9 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Prostate Symptom Score (IPSS)
Time Frame: 9 months
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Lawrence Hill, Pharm D, RPh, Watson Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 27, 2010

Last Update Submitted That Met QC Criteria

April 6, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.

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