Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin

• Status: Completed
• Trial end date: 2018-01-09

Summary

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of treatment in participants with hypercholesterolemia.

Secondary Objective:

• To evaluate the effect of two treatment regimens of alirocumab on other lipid parameters: apolipoprotein B (Apo-B), non-high-density lipoprotein cholesterol (non HDL-C), total cholesterol (TC), lipoprotein (a) (Lp[a]), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), and apolipoprotein A-1 (Apo A-1).

• To evaluate the safety and tolerability of alirocumab administration.

• To evaluate the development of anti-alirocumab antibodies.

• To evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab administration.

• To evaluate the long-term safety in participants receiving open-label alirocumab administration.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Atorvastatin; Atorvastatin Calcium; Bezafibrate; Ezetimibe; Fenofibrate; Hydroxymethylglutaryl-CoA Reductase Inhibitors