Hypercholesterolemia Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Alirocumab in Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy
Primary Objective:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as
add-on therapy to stable daily statin therapy with or without other lipid modifying therapy
in comparison with placebo after 24 weeks of treatment in heterozygous familial
hypercholesterolemia (HeFH) or high cardiovascular risk participants with
hypercholesterolemia.
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.
- To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C
after 52 weeks of treatment.
- To evaluate the safety and tolerability of alirocumab.
- To evaluate the development of anti-alirocumab antibodies.
- To evaluate the pharmacokinetics of alirocumab.
Total duration per participant of approximately 63 weeks (14 months) (screening: 3 weeks, double-blind treatment period: 52 weeks, and follow-up period: 8 weeks). ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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