Official Title: “ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study”

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).

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Alfuzosin
  • Alfuzosin 10 mg One tablet per day after evening meal

Primary Measures

• improvements in urinary symptoms and quality of life index
  • Time Frame: During all the study conduct
    Safety Issue?: No

Secondary Measures

• Improvement in sexual function
  • Time Frame: During all the study conduct
    Safety Issue?: No
• Improvement in maximum flow rate (determined by uroflowmetry)
  • Time Frame: During all the study conduct
    Safety Issue?: No
• Collection of spontaneously reported adverse events
  • Time Frame: At each visit
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Paibulsirijit Sompob Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00575913

Study ID Number: L_8935

ClinicalTrials.gov Identifier: NCT00575913

Health Authority: Thailand: Food and Drug Administration

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