Elevated Cholesterol and Heart Disease
A randomized, double blind, placebo-controlled, parallel-group study to evaluate the effect of SAR236553/REGN727 on the occurrence of cardiovascular events in patients who have recently experienced an acute coronary syndrome (Odyssey Outcomes).
Sponsored by Sanofi in collaboration with Regeneron Pharmaceuticals
The purpose of this study is to see if patients who have had a heart attack and who have high cholesterol that does not respond well enough to high doses of standard therapy with statins do better when treated with the investigational drug. The drug is a monoclonal antibody that is taken as a shot under the skin every two weeks.
Subjects will be randomly assigned to either the investigational drug or placebo and will be followed for up to 6 years. Up to 18,000 patients will enter the study at multiple sites around the world.
More information can be found here.