Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

To assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (Xatral XL) 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 BPH.

Exclusion Criteria:

• Patients requiring BPH surgery immediately or within the 12 following months:

• Acute renal obstruction

• Chronic renal obstruction

• Chronic renal failure from BPH

• Bladder stone

• Recurrent urinary tract infection

• Other bladder pathology such as cancer of the bladder, bladder bidiverticulum (big size)

• Hematuria from BPH

• Patients whose urinary symptoms are satisfactorily controlled on other BPH medication ( alpha-blockers or 5 alpha-reductase)

• Patients previously not improved by an alpha1-blocker treatment

• Known hypersensitivity to alfuzosin

• History of postural hypotension or syncope

• Combination with other alpha1-blockers

• Hepatic enzyme (SGOT or/and SGPT ) > 1.5 Upper Normal Limit

• Unstable angina pectoris

• Severe concomitant condition threatening life.

• Patients who had failed treatment with finasteride (Proscar)

• Patients with neuropathic bladder.

• Patients with history of previous surgery for BPH

• Patients with high risk for prostate cancer based on the clinical judgement of the investigator

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.