Clinical Trial in Males With BPH (Enlarged Prostate)

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00029822

Collaborator

(none)

1,522

Enrollment

Locations

Duration (Months)

28.2

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention Prostatic Hyperplasia Benign Prostatic Hypertrophy	Drug: Alfuzosin (SL770499)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1522 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

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 Start Date :

May 1, 2001

Actual Study Completion Date :

Mar 1, 2005

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Affiliated Research Center, Inc	Huntsville	Alabama	United States	35801
2	San Diego Urology Center	La Mesa	California	United States	91942
3	San Bernardino Urology Associates	San Bernardino	California	United States	92404
4	San Diego Urological Medical Group	San Diego	California	United States	92101
5	Pacific Clinical Research	Santa Monica	California	United States	90404
6	Urology Research Options	Aurora	Colorado	United States	80012
7	Connecticut Clinical Research Center	Waterbury	Connecticut	United States	06708-2652
8	South Florida Medical Research	Aventura	Florida	United States	33180
9	Tampa Bay Medical Research, Inc.	Clearwater	Florida	United States	34621
10	Advanced Research Institute	New Port Richey	Florida	United States	34652
11	Renstar Medical Research	Ocala	Florida	United States	34474
12	Renstar Medical Research	Plantation	Florida	United States	33324
13	Urology Associates	Marietta	Georgia	United States	30060
14	Northwestern Center for Clinical Research	Chicago	Illinois	United States	60611
15	Welborn Clinic	Evansville	Indiana	United States	47714
16	Northeast Indiana Research	Fort Wayne	Indiana	United States	46804-4128
17	Urology of Indiana, LLC	Indianapolis	Indiana	United States	46202
18	Maryland Prostate Cancer	Baltimore	Maryland	United States	21201
19	Maryland Urology Association	Towson	Maryland	United States	21204
20	Newton Wellesley Urology	Newton	Massachusetts	United States	02462
21	Lakeside Urology, P.C.	St. Joseph	Michigan	United States	49085-2521
22	Se Urology Network	Southaven	Mississippi	United States	38671
23	Weill Cornell Medical Center	New York	New York	United States	10021
24	Advanced Clinical Trials	Eugene	Oregon	United States	97401
25	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141
26	Center for Urologic Care	West Reading	Pennsylvania	United States	19611
27	Matrix Research	Greenville	South Carolina	United States	29650
28	Ut Medical Group, Inc.	Memphis	Tennessee	United States	38103-3446
29	Murfreesboro Medical Center	Murfreesboro	Tennessee	United States	37130
30	nTouch Research Corporation	Dallas	Texas	United States	75230
31	Urology Consultants, P.A.	San Antonio	Texas	United States	78229
32	Urology Associates	Fredericksburg	Virginia	United States	22401
33	Jeffrey Frankel	Seattle	Washington	United States	98166-3059
34	University of Wisconsin Hospital & Clinics	Madison	Wisconsin	United States	53792
35	Midwest Research Specialists, LLC	Milwaukee	Wisconsin	United States	53209
36	Sanofi-aventis Administrative Office	Macquarie Park		Australia
37	Sanofi-aventis Administrative Office	Sofia		Bulgaria
38	Sanofi-aventis Administrative Office	Laval		Canada
39	Sanofi-aventis Administrative Office	Horsholm		Denmark
40	Sanofi-aventis Administrative Office	Helsinki		Finland
41	Sanofi-aventis Administrative Office	Athens		Greece
42	Sanofi-aventis Administrative Office	Budapest		Hungary
43	Edith Wolfson Hospital	Holon		Israel	58100
44	Sapir Med. Center - Meir General Hospital	Kfar Saba		Israel	44281
45	Rabin Medical Center-Golda Campus	Petah Tikvah		Israel	44281
46	Sourasky Med. Center-Ichilov Hospital	Tel Aviv		Israel	44281
47	Sanofi-aventis Administrative Office	Gouda		Netherlands
48	Sanofi-aventis Administrative Office	Lysaker		Norway
49	Sanofi-aventis Administrative Office	Warszawa		Poland
50	Sanofi-aventis Administrative Office	Porto Salvo		Portugal
51	Sanofi-aventis Administrative Office	Bucuresti		Romania
52	Sanofi-aventis Administrative Office	Midrand		South Africa
53	Sanofi-aventis Administrative Office	Barcelona		Spain
54	Sanofi-aventis Administrative Office	Bromma		Sweden