Prostatic Diseases
Conditions
Brief 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).
Interventions
DRUGAlfuzosin
Alfuzosin 10 mg One tablet per day after evening meal
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvements in urinary symptoms and quality of life index | During all the study conduct |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in sexual function | During all the study conduct |
| Improvement in maximum flow rate (determined by uroflowmetry) | During all the study conduct |
| Collection of spontaneously reported adverse events | At each visit |
Countries
Thailand
Outcome results
None listed