drugset / Trial / NCT00718965

Evaluation of Efficacy and Safety of AVE5530 in Patients With Primary Hypercholesterolemia

NCT00718965

Phase 3 Terminated 826 enrolled Sanofi
RandomizedParallel-groupTriple-blindTreatment

Summary

The present study is aiming at assessing the efficacy and safety of AVE5530 (25mg and 50mg) in a double-blind comparison with placebo in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of AVE5530 on LDL-C level reduction as adjunct to a controlled diet. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

Timeline

Start
2008-07
Primary completion
2008-11
Completion
2009-06

Drugs

EvaluationDrugModalityDoseRoute
Subject CANOSIMIBE Small molecule 25 mg Oral
Subject CANOSIMIBE Small molecule 50 mg Oral

Indications