ALF-ONE : ALFuzosin ONcE Daily

Sanofi

Status and phase: Completed; Phase 4

Conditions: Prostatic Hyperplasia

Treatments: Drug: Alfuzosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00280605

PM_L_0168

Details and patient eligibility

About

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).

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)