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

A Long-term Safety and Efficacy of SL77.0499-10 10mg Once-daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).A Multicenter, 52-week, Open Label, Uncontrolled Study.

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.