ALF-ONE : ALFuzosin ONcE Daily

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Alfuzosin

Criteria

Inclusion Criteria:

• Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia

Exclusion Criteria:

• Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months

• Patients previously not improved by an alpha 1-blocker treatment

• Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI)

• Known hypersensitivity to alfuzosin

• History of postural hypotension or syncope

• Combination with other alpha 1-blockers

• Hepatic insufficiency

• Unstable angina pectoris

• Severe concomitant condition threatening life