drugset / Trial / NCT00347061

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

NCT00347061

Phase 3 Completed 148 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-05
Primary completion
2007-10
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Alfuzosin Small molecule 10 mg