Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
Status:
Completed
Trial end date:
2017-06-30
Target enrollment:
Participant gender:
Summary
Primary Objective:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of
Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin
lipid modifying background therapy or as monotherapy in comparison with placebo in
participants with primary hypercholesterolemia not treated with a statin.
Secondary Objective:
- To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus
placebo.
- To evaluate the safety and tolerability of Alirocumab 150 mg Q4W.
Alirocumab 75 mg Q2W was added as a calibrator arm.