Overview

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.