At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy in South Korea and Taiwan
In Brief
A Phase 3 clinical trial evaluating Placebo (for Alirocumab), Alirocumab, and 1 other intervention for Hypercholesterolemia. Completed, enrolled 199 participants across 27 sites in 2 countries.
Detailed 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).
Study Details
Timeline
Interventions
Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.
Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.
Statins (Rosuvastatin, Simvastatin or Atorvastatin) at stable dose with or without other LMT as clinically indicated.