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Clinical Trial in Males With BPH (Enlarged Prostate)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00029822
First received: January 23, 2002
Last updated: June 6, 2008
Last verified: June 2008
History of Changes
  Purpose

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 Intervention Phase
Urinary Retention
Prostatic Hyperplasia
Benign Prostatic Hypertrophy
 Drug: Alfuzosin (SL770499)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

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

Enrollment: 1522
Study Start Date: May 2001
Study Completion Date: March 2005
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00029822

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00029822     History of Changes
Other Study ID Numbers: EFC4485, SL770499
Study First Received: January 23, 2002
Last Updated: June 6, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 23, 2013