NCT00290030

ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH

A Double-Blind Randomized Parallel Group Study of Alfuzosin 10mg OD Versus Placebo in the Management of Acute Urinary Retention in Patients With a First Episode Due to Benign Prostatic Hyperplasia (BPH)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of alfuzosin 10mg OD in the management of acute urinary retention associated with BPH. To assess the safety of alfuzosin in this population and health care consumption.

Detailed description

Double-blind, placebo controlled, randomized Multicenter, Phase III study comparing 2 parallel groups (alfuzosin 10mg OD or placebo) in patients with a first episode of acute urinary retention related to BPH.The acute episode is managed with catheterization and with study drug treatment for 2 to 3 days, followed by an active voiding trial to assess the patients' ability to void after catheter removal. Those patients who successfully void will continue their randomized treatment for a total treatment duration of 6 months. For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

Conditions

• Prostatic Hyperplasia
• Acute Urinary Retention

Interventions

Type	Name	Description
DRUG	Alfuzosin

Timeline

• Start date: 2001-05-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2006-02-10
• Last updated: 2009-03-12