Overview
Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study
Status:
Completed
Completed
Trial end date:
2005-03-01
2005-03-01
Target enrollment:
0
0
Participant gender:
Male
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 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
SanofiTreatments:
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.