Clinical Trial in Males With BPH (Enlarged Prostate) - Full Text View

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

Drug Information available for:

Alfuzosin Alfuzosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

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

Related Info This link exits the ClinicalTrials.gov site

Publications of Results:

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:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC4485, SL770499
First Received:	January 23, 2002
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00029822
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

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Hypertrophy

Hyperplasia

Alfuzosin

Urologic Diseases

Prostatic Diseases

Prostatic Hyperplasia

Urination Disorders

Genital Diseases, Male

Urinary Retention

Additional relevant MeSH terms:

Neurotransmitter Agents

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Therapeutic Uses

Physiological Effects of Drugs

Adrenergic Antagonists

Cardiovascular Agents

Adrenergic alpha-Antagonists

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

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