Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH
Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH
Primary:

 To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients
 with lower urinary tract symptoms related to BPH.

 Secondary:

 -  To provide the information on the efficacy of SL77.0499-10 10mg administered once daily
 for one year in patients with lower urinary tract symptoms related to BPH.

 -  To document the plasma concentration of SL77.0499-10 after repeated administration of
 SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms
 related to BPH.
Inclusion Criteria:

 -  Having a symptomatic BPH diagnosed clinically by digital rectal examination and
 ultrasonography

 -  Suffering for at least 6 months from lower urinary tract symptoms related to BPH

 -  An I-PSS total score ≥ 13

 -  Out patient

 Exclusion Criteria:

 -  Patients previously treated with SL77.0499-10.

 -  Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology.

 -  Isolated bladder neck disease.

 -  Diagnosed carcinoma of the prostate.

 -  Previous prostatic surgery or other invasive procedures (thermotherapy…) for the
 treatment of BPH.

 -  Patients having an indwelling catheter.

 -  A residual urine > 200mL.

 -  Patients with Moderate or sever hepatic insufficiency.

 -  Known hypersensitivity to alpha1-blockers.

 -  Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH
 analogues within the previous 3 months before Screening

 -  Patients judged inappropriate for admission to the study by the Investigator or the
 Sub-Investigator.