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 Evaluating the Efficacy and Safety of Alirocumab in Patients With Primary Hypercholesterolemia Not Treated With a Statin
In Brief
A Phase 3 clinical trial evaluating Alirocumab, Placebo (for Alirocumab), and 2 other interventions for Hypercholesterolemia. Completed, enrolled 233 participants across 43 sites in 8 countries.
Detailed Summary
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants with primary hypercholesterolemia not treated with a statin. Secondary Objective: * To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus placebo. * To evaluate the safety and tolerability of Alirocumab 150 mg Q4W. Alirocumab 75 mg Q2W was added as a calibrator arm.
Study Details
Timeline
Interventions
Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).
Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).
Ezetimibe or Fenofibrate at stable dose as background therapy.
Stable cholesterol-lowering diet as background therapy.