ALF-ONE : ALFuzosin ONcE Daily

Sanofi200 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Prostatic Hyperplasia

Interventions

AlfuzosinDRUG

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Spontaneous adverse events

Blood pressure and heart rate measured in sitting position

International Prostate Symptom Score (IPSS) and quality of life index

DAN-PSS sexual function score

PSA levels measured at baseline

Maximum flow rate and residual urine

Data from ClinicalTrials.gov

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