Clinical Trial in Males With BPH (Enlarged Prostate)
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.
2 other identifiers
interventional
1,522
17 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2001
Typical duration for phase_3
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedFirst Submitted
Initial submission to the registry
January 23, 2002
CompletedFirst Posted
Study publicly available on registry
January 24, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedJune 9, 2008
June 1, 2008
January 23, 2002
June 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
occurrence of first episode of acute urinary retention (AUR)
Secondary Outcomes (1)
need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Sanofilead
Study Sites (54)
Medical Affiliated Research Center, Inc
Huntsville, Alabama, 35801, United States
San Diego Urology Center
La Mesa, California, 91942, United States
San Bernardino Urology Associates
San Bernardino, California, 92404, United States
San Diego Urological Medical Group
San Diego, California, 92101, United States
Pacific Clinical Research
Santa Monica, California, 90404, United States
Urology Research Options
Aurora, Colorado, 80012, United States
Connecticut Clinical Research Center
Waterbury, Connecticut, 06708-2652, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 34621, United States
Advanced Research Institute
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34474, United States
Renstar Medical Research
Plantation, Florida, 33324, United States
Urology Associates
Marietta, Georgia, 30060, United States
Northwestern Center for Clinical Research
Chicago, Illinois, 60611, United States
Welborn Clinic
Evansville, Indiana, 47714, United States
Northeast Indiana Research
Fort Wayne, Indiana, 46804-4128, United States
Urology of Indiana, LLC
Indianapolis, Indiana, 46202, United States
Maryland Prostate Cancer
Baltimore, Maryland, 21201, United States
Maryland Urology Association
Towson, Maryland, 21204, United States
Newton Wellesley Urology
Newton, Massachusetts, 02462, United States
Lakeside Urology, P.C.
Saint Joseph, Michigan, 49085-2521, United States
Se Urology Network
Southaven, Mississippi, 38671, United States
Weill Cornell Medical Center
New York, New York, 10021, United States
Advanced Clinical Trials
Eugene, Oregon, 97401, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Center for Urologic Care
West Reading, Pennsylvania, 19611, United States
Matrix Research
Greenville, South Carolina, 29650, United States
Ut Medical Group, Inc.
Memphis, Tennessee, 38103-3446, United States
Murfreesboro Medical Center
Murfreesboro, Tennessee, 37130, United States
nTouch Research Corporation
Dallas, Texas, 75230, United States
Urology Consultants, P.A.
San Antonio, Texas, 78229, United States
Urology Associates
Fredericksburg, Virginia, 22401, United States
Jeffrey Frankel
Seattle, Washington, 98166-3059, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792, United States
Midwest Research Specialists, LLC
Milwaukee, Wisconsin, 53209, United States
Sanofi-aventis Administrative Office
Macquarie Park, Australia
Sanofi-aventis Administrative Office
Sofia, Bulgaria
Sanofi-aventis Administrative Office
Laval, Canada
Sanofi-aventis Administrative Office
Hørsholm, Denmark
Sanofi-aventis Administrative Office
Helsinki, Finland
Sanofi-aventis Administrative Office
Athens, Greece
Sanofi-aventis Administrative Office
Budapest, Hungary
Edith Wolfson Hospital
Holon, 58100, Israel
Sapir Med. Center - Meir General Hospital
Kfar Saba, 44281, Israel
Rabin Medical Center-Golda Campus
Petah Tikvah, 44281, Israel
Sourasky Med. Center-Ichilov Hospital
Tel Aviv, 44281, Israel
Sanofi-aventis Administrative Office
Gouda, Netherlands
Sanofi-aventis Administrative Office
Lysaker, Norway
Sanofi-aventis Administrative Office
Warsaw, Poland
Sanofi-aventis Administrative Office
Porto Salvo, Portugal
Sanofi-aventis Administrative Office
Bucharest, Romania
Sanofi-aventis Administrative Office
Midrand, South Africa
Sanofi-aventis Administrative Office
Barcelona, Spain
Sanofi-aventis Administrative Office
Bromma, Sweden
Related Publications (1)
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.
PMID: 16536764RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 23, 2002
First Posted
January 24, 2002
Study Start
May 1, 2001
Study Completion
March 1, 2005
Last Updated
June 9, 2008
Record last verified: 2008-06