At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia
In Brief
A Phase 3 clinical trial evaluating Evolocumab, Ezetimibe, and 5 other interventions for Hyperlipidemia. Completed, enrolled 2,067 participants across 244 sites in 21 countries.
Detailed Summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.
Study Details
Timeline
Interventions
Administered by subcutaneous injection
Administered orally once a day
Administered by subcutaneous injection
Administered orally once a day
Administered orally once a day
Administered orally once a day
Administered orally once a day