Overview

Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan

Status:
Completed

Trial end date:
2016-04-01

Target enrollment:

Participant gender:

Summary

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment. - To evaluate the effect 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), triglycerides (TGs), and apolipoprotein A-1 (Apo A-1). - To evaluate the safety and tolerability of alirocumab. - To evaluate the development of anti-alirocumab antibodies (ADA).

Phase:

Phase 3

Details

Lead Sponsor:

Sanofi

Collaborator:

Regeneron Pharmaceuticals

Treatments:

Antibodies, Monoclonal