Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Diseases
Intervention: Alfuzosin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Paibulsirijit Sompob, Study Director, Affiliation: Sanofi
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).
Clinical Details
Official title: ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: improvements in urinary symptoms and quality of life index
Secondary outcome: Improvement in sexual functionImprovement in maximum flow rate (determined by uroflowmetry) Collection of spontaneously reported adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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.
Locations and Contacts
Sanofi-Aventis, Bangkok, Thailand
Additional Information
Starting date: September 2003
Last updated: April 8, 2008
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