ALF-ONE : ALFuzosin ONcE Daily
Phase 4
Completed
- Conditions
- Prostatic Hyperplasia
- Registration Number
- NCT00280605
- Lead Sponsor
- Sanofi
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method