Hypercholesterolemia Clinical Trial
Official title:
A Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy
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 in comparison to ezetimibe
10 mg daily after 24 weeks of treatment in Asia in participants with hypercholesterolemia at
high cardiovascular (CV) risk.
Secondary Objectives:
- To evaluate the effect of alirocumab 75 mg in comparison with ezetimibe 10 mg on LDL-C
after 12 weeks of treatment.
- To evaluate the effect of alirocumab on other lipid parameters: e.g., apolipoprotein B
(Apo B), non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC),
lipoprotein a (Lp[a]), HDL-C, triglycerides (TG), apolipoprotein A-1 (Apo A-1).
- To evaluate the safety and tolerability of alirocumab.
- To evaluate the development of anti-alirocumab antibodies.
- To evaluate the pharmacokinetics (PK) of alirocumab.
The maximum study duration was 35 weeks per participant, which included a screening period of up to 3 weeks, a 24-week randomized treatment period, and an 8-week post-treatment follow-up period. ;
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