A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

Last updated: December 11, 2009
Sponsor: Watson Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Bladder Disorders

Prostate Disorders

Treatment

N/A

Clinical Study ID

NCT00224120
SI04010
  • Ages > 50
  • Male

Study Summary

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males in good general health and at least 50 years of age, with symptoms of moderateto severe BPH.

Exclusion

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 Design

Total Participants: 462
Study Start date:
May 01, 2005
Estimated Completion Date:
May 31, 2006

Study Description

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Connect with a study center

  • Birmingham, Alabama
    United States

    Site Not Available

  • Carmichael, California
    United States

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  • Fresno, California
    United States

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  • Laguna Woods, California
    United States

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  • San Bernardino, California
    United States

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  • Tarzana, California
    United States

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  • Torrance, California
    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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  • 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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  • Chicago, Illinois
    United States

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  • Melrose Park, Illinois
    United States

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  • Evansville, Indiana
    United States

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  • Fort Wayne, Indiana
    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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  • Jackson, Mississippi
    United States

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  • Kansas City, Missouri
    United States

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  • Lawrenceville, New Jersey
    United States

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  • Voorhees, 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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  • Garden City, New York
    United States

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  • Kingston, New York
    United States

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  • Poughkeepsie, New York
    United States

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  • Concord, North Carolina
    United States

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  • Cincinnati, Ohio
    United States

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  • Portland, Oregon
    United States

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  • Providence, Rhode Island
    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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  • Norfolk, Virginia
    United States

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  • Seattle, Washington
    United States

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  • Tacoma, Washington
    United States

    Site Not Available

  • Madison, Wisconsin
    United States

    Site Not Available

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