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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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.