Clinical Trial in Males With BPH (Enlarged Prostate)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00029822
Recruitment Status : Completed
First Posted : January 24, 2002
Last Update Posted : June 9, 2008
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Brief Summary:

A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH.

  • Free study-related medical care provided.

Condition or disease Intervention/treatment Phase
Urinary Retention Prostatic Hyperplasia Benign Prostatic Hypertrophy Drug: Alfuzosin (SL770499) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1522 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Long-Term, Efficacy and Safety of Alfuzosin 10 MG OD on the Risk of Acute Urinary Retention and the Need for Surgery in Patients With BPH. A Two Year, Randomized, Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Study.
Study Start Date : May 2001
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. occurrence of first episode of acute urinary retention (AUR)

Secondary Outcome Measures :
  1. need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
  • Has been suffering for at least 6 months with any of the following symptoms:
  • daytime or nighttime urinary frequency
  • urgent feeling to urinate
  • difficulty starting urinary stream
  • interruption of urinary stream
  • feeling of incomplete urination
  • Has not had a previous episode of acute urinary retention
  • Has not been diagnosed with prostate cancer
  • Has not had previous prostate surgery
  • Is not an insulin-dependent diabetic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00029822

  Show 54 Study Locations
Sponsors and Collaborators
Study Director: ICD CSD Sanofi

Additional Information:
Publications of Results:
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00029822     History of Changes
Other Study ID Numbers: EFC4485
First Posted: January 24, 2002    Key Record Dates
Last Update Posted: June 9, 2008
Last Verified: June 2008

Keywords provided by Sanofi:
Acute Urinary Retention
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Enlarged Prostate

Additional relevant MeSH terms:
Prostatic Hyperplasia
Urinary Retention
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents