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:

MedlinePlus related topics: Enlarged Prostate (BPH)

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:

Roehrborn CG. Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention: results of a 2-year placebo-controlled study. BJU Int. 2006 Apr;97(4):734-41.


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:


Hyperplasia Prostatic Hyperplasia Hypertrophy Urinary Retention Pathologic Processes Prostatic Diseases Genital Diseases, Male 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

ClinicalTrials.gov processed this record on September 26, 2016

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