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.
Phase 3
55 Years
N/A
55 Years
N/A
Not Enrolling
Male
Urinary Retention, Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Male
Urinary Retention, Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Trial Information
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
occurrence of first episode of acute urinary retention (AUR)
Principal Investigator
ICD CSD
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Food and Drug Administration
Study ID:
EFC4485
NCT ID:
NCT00029822
Start Date:
May 2001
Completion Date:
March 2005
Related Keywords:
- Urinary Retention
- Prostatic Hyperplasia
- Benign Prostatic Hypertrophy
- Acute Urinary Retention
- AUR
- Benign Prostatic Hyperplasia
- Benign Prostatic Hypertrophy
- BPH
- Enlarged Prostate
- Prostatic Hyperplasia
- Hyperplasia
- Hypertrophy
- Urinary Retention
Name | Location |
|---|---|
| San Diego Urology Center | La Mesa, California 91942 |
| South Florida Medical Research | Aventura, Florida 33180 |
| Newton Wellesley Urology | Newton, Massachusetts 02162 |
| Albert Einstein Medical Center | Philadelphia, Pennsylvania 19141 |
| Medical Affiliated Research Center, Inc | Huntsville, Alabama 35801 |
| San Bernardino Urology Associates | San Bernardino, California 92404 |
| San Diego Urological Medical Group | San Diego, California 92101 |
| Pacific Clinical Research | Santa Monica, California 90404 |
| Urology Research Options | Aurora, Colorado 80012 |
| Connecticut Clinical Research Center | Waterbury, Connecticut 06708-2652 |
| Tampa Bay Medical Research, Inc. | Clearwater, Florida 34621 |
| Advanced Research Institute | New Port Richey, Florida 34652 |
| Renstar Medical Research | Ocala, Florida 34474 |
| Urology Associates | Marietta, Georgia 30060 |
| Northwestern Center for Clinical Research | Chicago, Illinois 60611 |
| Welborn Clinic | Evansville, Indiana 47714 |
| Northeast Indiana Research | Fort Wayne, Indiana 46804-4128 |
| Urology of Indiana, LLC | Indianapolis, Indiana 46202 |
| Maryland Prostate Cancer | Baltimore, Maryland 21201 |
| Maryland Urology Association | Towson, Maryland 21204 |
| Lakeside Urology, P.C. | St. Joseph, Michigan 49085-2521 |
| Se Urology Network | Southaven, Mississippi 38671 |
| Weill Cornell Medical Center | New York, New York 10021 |
| Advanced Clinical Trials | Eugene, Oregon 97401 |
| Center for Urologic Care | West Reading, Pennsylvania 19611 |
| Matrix Research | Greenville, South Carolina 29650 |
| Ut Medical Group, Inc. | Memphis, Tennessee 38103-3446 |
| Murfreesboro Medical Center | Murfreesboro, Tennessee 37130 |
| nTouch Research Corporation | Dallas, Texas 75230 |
| Urology Consultants, P.A. | San Antonio, Texas 78229 |
| Urology Associates | Fredericksburg, Virginia 22401 |
| Jeffrey Frankel | Seattle, Washington 98166-3059 |
| University of Wisconsin Hospital & Clinics | Madison, Wisconsin 53792 |
| Midwest Research Specialists, LLC | Milwaukee, Wisconsin 53209 |
