Benign Prostatic Hyperplasia
Conditions
Brief summary
Collection of the data on the safety and efficacy of the once daily administration of the alfuzosin preparation /Alfetim Uno® l0 mg/ at patients with lower urinary tract symptoms/complaints rendering possible the presence of benign prostatic hyperplasia, in the course of everyday practice
Interventions
DRUGAlfuzosin
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present
Exclusion criteria
* Necessity of surgical intervention immediately or within 12 months because of BPH * The patient has earlier /within 6 months/ obtained treatment because of BPH * The patient did not improve on earlier alpha-1 blocker treatment * Known hypersensitivity to alfuzosin * Orthostatic hypotension in the history * Concomitant application with another alpha-1 blocker * Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/ * Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/ * Intestinal obstruction /because of the castor oil content of the drug/ * Tumorous disease * Severe, life threatening state 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 |
|---|---|
| To collect additional clinical data on the safety profile and efficacy of alfuzosin 10 mg o. d. in patients with low-urinary tract symptoms caused by benign prostatic hyperplasia (BPH) | 6 months |
Countries
Hungary
Outcome results
None listed