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Clinical Trial in Males With BPH (Enlarged Prostate)

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ClinicalTrials.gov Identifier: NCT00029822
Recruitment Status : Completed
First Posted : January 24, 2002
Last Update Posted : June 9, 2008
Sponsor:
Information provided by:
Sanofi

Study Description
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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 Design
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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
Actual Study Completion Date : March 2005

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Arms and Interventions
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Outcome Measures
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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)

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes 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
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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 ClinicalTrials.gov identifier (NCT number): NCT00029822


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

Publications of Results:

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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00029822    
Other Study ID Numbers: EFC4485
SL770499
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
AUR
Benign Prostatic Hyperplasia
 Benign Prostatic Hypertrophy
BPH
Enlarged Prostate
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Urinary Retention
Hyperplasia
Hypertrophy
Pathologic Processes
Prostatic Diseases
Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases
 Alfuzosin
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