Hypercholesterolemia Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
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.
The duration of study per participant was approximately 71 weeks consisting of a run-in period (4 weeks), a screening period (3 weeks), a double-blind treatment period (12 weeks), and an open-label treatment period (52 weeks). ;
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