Clinical Trial in Males With BPH (Enlarged Prostate) - Tabular View

Tracking Information

First Received Date ^ICMJE

January 23, 2002

Last Updated Date

June 6, 2008

Start Date ^ICMJE

May 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

occurrence of first episode of acute urinary retention (AUR)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00029822 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Clinical Trial in Males With BPH (Enlarged Prostate)

Official Title ^ICMJE

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.

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Urinary Retention
Prostatic Hyperplasia
Benign Prostatic Hypertrophy

Intervention ^ICMJE

Drug: Alfuzosin (SL770499)

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1522

Completion Date

March 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Bulgaria, Canada, Denmark, Finland, Greece, Hungary, Israel, Netherlands, Norway, Poland, Portugal, Romania, South Africa, Spain, Sweden

Administrative Information

NCT ID ^ICMJE

NCT00029822

Responsible Party

ICD Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

EFC4485, SL770499

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP