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Clinical Trial in Males With BPH (Enlarged Prostate)

Primary Purpose

Urinary Retention, Prostatic Hyperplasia, Benign Prostatic Hypertrophy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alfuzosin (SL770499)
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Retention focused on measuring Acute Urinary Retention, AUR, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, BPH, Enlarged Prostate

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Affiliated Research Center, Inc
  • San Diego Urology Center
  • San Bernardino Urology Associates
  • San Diego Urological Medical Group
  • Pacific Clinical Research
  • Urology Research Options
  • Connecticut Clinical Research Center
  • South Florida Medical Research
  • Tampa Bay Medical Research, Inc.
  • Advanced Research Institute
  • Renstar Medical Research
  • Renstar Medical Research
  • Urology Associates
  • Northwestern Center for Clinical Research
  • Welborn Clinic
  • Northeast Indiana Research
  • Urology of Indiana, LLC
  • Maryland Prostate Cancer
  • Maryland Urology Association
  • Newton Wellesley Urology
  • Lakeside Urology, P.C.
  • Se Urology Network
  • Weill Cornell Medical Center
  • Advanced Clinical Trials
  • Albert Einstein Medical Center
  • Center for Urologic Care
  • Matrix Research
  • Ut Medical Group, Inc.
  • Murfreesboro Medical Center
  • nTouch Research Corporation
  • Urology Consultants, P.A.
  • Urology Associates
  • Jeffrey Frankel
  • University of Wisconsin Hospital & Clinics
  • Midwest Research Specialists, LLC
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Edith Wolfson Hospital
  • Sapir Med. Center - Meir General Hospital
  • Rabin Medical Center-Golda Campus
  • Sourasky Med. Center-Ichilov Hospital
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office

Outcomes

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)

Full Information

First Posted
January 23, 2002
Last Updated
June 6, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00029822
Brief Title
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

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Keywords
Acute Urinary Retention, AUR, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, BPH, Enlarged Prostate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1522 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alfuzosin (SL770499)
Primary Outcome Measure Information:
Title
occurrence of first episode of acute urinary retention (AUR)
Secondary Outcome Measure Information:
Title
need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Medical Affiliated Research Center, Inc
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
San Diego Urology Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
San Bernardino Urology Associates
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
San Diego Urological Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Pacific Clinical Research
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Urology Research Options
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Connecticut Clinical Research Center
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708-2652
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Tampa Bay Medical Research, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
34621
Country
United States
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Renstar Medical Research
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Urology Associates
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Welborn Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Northeast Indiana Research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804-4128
Country
United States
Facility Name
Urology of Indiana, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Maryland Prostate Cancer
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Maryland Urology Association
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Newton Wellesley Urology
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Lakeside Urology, P.C.
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085-2521
Country
United States
Facility Name
Se Urology Network
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Advanced Clinical Trials
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Center for Urologic Care
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Matrix Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Ut Medical Group, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103-3446
Country
United States
Facility Name
Murfreesboro Medical Center
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
nTouch Research Corporation
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Urology Consultants, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Urology Associates
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
Facility Name
Jeffrey Frankel
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166-3059
Country
United States
Facility Name
University of Wisconsin Hospital & Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Midwest Research Specialists, LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Sanofi-aventis Administrative Office
City
Macquarie Park
Country
Australia
Facility Name
Sanofi-aventis Administrative Office
City
Sofia
Country
Bulgaria
Facility Name
Sanofi-aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-aventis Administrative Office
City
Horsholm
Country
Denmark
Facility Name
Sanofi-aventis Administrative Office
City
Helsinki
Country
Finland
Facility Name
Sanofi-aventis Administrative Office
City
Athens
Country
Greece
Facility Name
Sanofi-aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Edith Wolfson Hospital
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Sapir Med. Center - Meir General Hospital
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center-Golda Campus
City
Petah Tikvah
ZIP/Postal Code
44281
Country
Israel
Facility Name
Sourasky Med. Center-Ichilov Hospital
City
Tel Aviv
ZIP/Postal Code
44281
Country
Israel
Facility Name
Sanofi-aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-aventis Administrative Office
City
Lysaker
Country
Norway
Facility Name
Sanofi-aventis Administrative Office
City
Warszawa
Country
Poland
Facility Name
Sanofi-aventis Administrative Office
City
Porto Salvo
Country
Portugal
Facility Name
Sanofi-aventis Administrative Office
City
Bucuresti
Country
Romania
Facility Name
Sanofi-aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-aventis Administrative Office
City
Bromma
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
16536764
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.
Results Reference
result
Links:
URL
http://centerwatch.com
Description
Related Info
URL
http://www.sanofi-aventis.com
Description
Related Info

Learn more about this trial

Clinical Trial in Males With BPH (Enlarged Prostate)

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