drugset / Trial / NCT00729027

Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia

NCT00729027

Phase 3 Terminated 1015 enrolled Sanofi
RandomizedParallel-groupTriple-blindTreatment

Summary

The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing statin treatment in a double-blind manner in comparison with placebo, in the management of patients with primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment. The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

Timeline

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

Drugs

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

Indications