Clinical Trial in Males With BPH (Enlarged Prostate)

This study has been completed.

First Received on January 23, 2002. Last Updated on June 6, 2008 History of Changes

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00029822

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 III

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:

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

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-Aventis:

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 February 09, 2012