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

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:	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.

Resource links provided by NLM:

MedlinePlus related topics: Surgery

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

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Locations

United States, Alabama
Medical Affiliated Research Center, Inc
Huntsville, Alabama, United States, 35801
United States, California
San Diego Urology Center
La Mesa, California, United States, 91942
Pacific Clinical Research
Santa Monica, California, United States, 90404
San Bernardino Urology Associates
San Bernardino, California, United States, 92404
San Diego Urological Medical Group
San Diego, California, United States, 92101
United States, Colorado
Urology Research Options
Aurora, Colorado, United States, 80012
United States, Connecticut
Connecticut Clinical Research Center
Waterbury, Connecticut, United States, 06708-2652
United States, Florida
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States, 34621
South Florida Medical Research
Aventura, Florida, United States, 33180
Renstar Medical Research
Plantation, Florida, United States, 33324
Renstar Medical Research
Ocala, Florida, United States, 34474
Advanced Research Institute
New Port Richey, Florida, United States, 34652
United States, Georgia
Urology Associates
Marietta, Georgia, United States, 30060
United States, Illinois
Northwestern Center for Clinical Research
Chicago, Illinois, United States, 60611
United States, Indiana
Urology of Indiana, LLC
Indianapolis, Indiana, United States, 46202
Welborn Clinic
Evansville, Indiana, United States, 47714
Northeast Indiana Research
Fort Wayne, Indiana, United States, 46804-4128
United States, Maryland
Maryland Prostate Cancer
Baltimore, Maryland, United States, 21201
Maryland Urology Association
Towson, Maryland, United States, 21204
United States, Massachusetts
Newton Wellesley Urology
Newton, Massachusetts, United States, 02462
United States, Michigan
Lakeside Urology, P.C.
St. Joseph, Michigan, United States, 49085-2521
United States, Mississippi
Se Urology Network
Southaven, Mississippi, United States, 38671
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10021
United States, Oregon
Advanced Clinical Trials
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Center for Urologic Care
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Matrix Research
Greenville, South Carolina, United States, 29650
United States, Tennessee
Ut Medical Group, Inc.
Memphis, Tennessee, United States, 38103-3446
Murfreesboro Medical Center
Murfreesboro, Tennessee, United States, 37130
United States, Texas
nTouch Research Corporation
Dallas, Texas, United States, 75230
Urology Consultants, P.A.
San Antonio, Texas, United States, 78229
United States, Virginia
Urology Associates
Fredericksburg, Virginia, United States, 22401
United States, Washington
Jeffrey Frankel
Seattle, Washington, United States, 98166-3059
United States, Wisconsin
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States, 53792
Midwest Research Specialists, LLC
Milwaukee, Wisconsin, United States, 53209
Australia
Sanofi-aventis Administrative Office
Macquarie Park, Australia
Bulgaria
Sanofi-aventis Administrative Office
Sofia, Bulgaria
Canada
Sanofi-aventis Administrative Office
Laval, Canada
Denmark
Sanofi-aventis Administrative Office
Horsholm, Denmark
Finland
Sanofi-aventis Administrative Office
Helsinki, Finland
Greece
Sanofi-aventis Administrative Office
Athens, Greece
Hungary
Sanofi-aventis Administrative Office
Budapest, Hungary
Israel
Rabin Medical Center-Golda Campus
Petah Tikvah, Israel, 44281
Sourasky Med. Center-Ichilov Hospital
Tel Aviv, Israel, 44281
Sapir Med. Center - Meir General Hospital
Kfar Saba, Israel, 44281
Edith Wolfson Hospital
Holon, Israel, 58100
Netherlands
Sanofi-aventis Administrative Office
Gouda, Netherlands
Norway
Sanofi-aventis Administrative Office
Lysaker, Norway
Poland
Sanofi-aventis Administrative Office
Warszawa, Poland
Portugal
Sanofi-aventis Administrative Office
Porto Salvo, Portugal
Romania
Sanofi-aventis Administrative Office
Bucuresti, Romania
South Africa
Sanofi-aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-aventis Administrative Office
Bromma, Sweden

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

Pathological Conditions, Anatomical
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Prostatic Diseases
Urination Disorders
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Urinary Retention

Genital Diseases, Male
Pharmacologic Actions
Hyperplasia
Hypertrophy
Pathologic Processes
Alfuzosin
Prostatic Hyperplasia
Urologic Diseases
Therapeutic Uses
Adrenergic Antagonists

ClinicalTrials.gov processed this record on November 27, 2009