At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia
In Brief
A Phase 3 clinical trial evaluating Placebo (for alirocumab), Alirocumab, and 1 other intervention for Hypercholesterolemia. Completed, enrolled 803 participants across 83 sites in 8 countries.
Detailed Summary
To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.
Study Details
Timeline
Interventions
Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy