Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study

Prostatic Diseases Clinical Trial

— ALEX-XL  

Official title:

ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575913
• Other study ID #: L_8935
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2007
• Last updated: April 8, 2008
• Start date: September 2003
• Est. completion date: March 2005

Study information

• Verified date: April 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Prostatic Diseases

Intervention

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

Locations

Country	Name	City	State
Thailand	Sanofi-Aventis	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvements in urinary symptoms and quality of life index		During all the study conduct	No
Secondary	Improvement in sexual function		During all the study conduct	No
Secondary	Improvement in maximum flow rate (determined by uroflowmetry)		During all the study conduct	No
Secondary	Collection of spontaneously reported adverse events		At each visit	Yes