Clinical trial NCT00029822: Clinical Trial in Males With BPH (Enlarged Prostate)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Retention
Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Keywords: Acute Urinary Retention
AUR
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
BPH
Enlarged Prostate
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2002-01-24
Enrollment: 1522
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: occurrence of first episode of acute urinary retention (AUR)
Secondary outcomes:
measure: need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc
state: Alabama
city: La Mesa
country: United States
facility: San Diego Urology Center
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urology Associates
state: California
city: San Diego
country: United States
facility: San Diego Urological Medical Group
state: California
city: Santa Monica
country: United States
facility: Pacific Clinical Research
state: California
city: Aurora
country: United States
facility: Urology Research Options
state: Colorado
city: Waterbury
country: United States
facility: Connecticut Clinical Research Center
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Plantation
country: United States
facility: Renstar Medical Research
state: Florida
city: Marietta
country: United States
facility: Urology Associates
state: Georgia
city: Chicago
country: United States
facility: Northwestern Center for Clinical Research
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Fort Wayne
country: United States
facility: Northeast Indiana Research
state: Indiana
city: Indianapolis
country: United States
facility: Urology of Indiana, LLC
state: Indiana
city: Baltimore
country: United States
facility: Maryland Prostate Cancer
state: Maryland
city: Towson
country: United States
facility: Maryland Urology Association
state: Maryland
city: Newton
country: United States
facility: Newton Wellesley Urology
state: Massachusetts
city: St. Joseph
country: United States
facility: Lakeside Urology, P.C.
state: Michigan
city: Southaven
country: United States
facility: Se Urology Network
state: Mississippi
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Eugene
country: United States
facility: Advanced Clinical Trials
state: Oregon
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: West Reading
country: United States
facility: Center for Urologic Care
state: Pennsylvania
city: Greenville
country: United States
facility: Matrix Research
state: South Carolina
city: Memphis
country: United States
facility: Ut Medical Group, Inc.
state: Tennessee
city: Murfreesboro
country: United States
facility: Murfreesboro Medical Center
state: Tennessee
city: Dallas
country: United States
facility: nTouch Research Corporation
state: Texas
city: San Antonio
country: United States
facility: Urology Consultants, P.A.
state: Texas
city: Fredericksburg
country: United States
facility: Urology Associates
state: Virginia
city: Seattle
country: United States
facility: Jeffrey Frankel
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Midwest Research Specialists, LLC
state: Wisconsin
city: Macquarie Park
country: Australia
facility: Sanofi-aventis Administrative Office
city: Sofia
country: Bulgaria
facility: Sanofi-aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-aventis Administrative Office
city: Horsholm
country: Denmark
facility: Sanofi-aventis Administrative Office
city: Helsinki
country: Finland
facility: Sanofi-aventis Administrative Office
city: Athens
country: Greece
facility: Sanofi-aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi-aventis Administrative Office
city: Holon
country: Israel
facility: Edith Wolfson Hospital
city: Kfar Saba
country: Israel
facility: Sapir Med. Center - Meir General Hospital
city: Petah Tikvah
country: Israel
facility: Rabin Medical Center-Golda Campus
city: Tel Aviv
country: Israel
facility: Sourasky Med. Center-Ichilov Hospital
city: Gouda
country: Netherlands
facility: Sanofi-aventis Administrative Office
city: Lysaker
country: Norway
facility: Sanofi-aventis Administrative Office
city: Warszawa
country: Poland
facility: Sanofi-aventis Administrative Office
city: Porto Salvo
country: Portugal
facility: Sanofi-aventis Administrative Office
city: Bucuresti
country: Romania
facility: Sanofi-aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1111/j.1464-410X.2006.06110.x.