Clinical Trial in Males With BPH (Enlarged Prostate)

June 6, 2008 updated by: Sanofi

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1522

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
occurrence of first episode of acute urinary retention (AUR)

Secondary Outcome Measures

Outcome Measure
need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

January 23, 2002

First Submitted That Met QC Criteria

January 23, 2002

First Posted (Estimate)

January 24, 2002

Study Record Updates

Last Update Posted (Estimate)

June 9, 2008

Last Update Submitted That Met QC Criteria

June 6, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC4485
  • SL770499

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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