drugset / Trial / NCT02634580

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4

NCT02634580

Phase 3 Completed 61 enrolled Amgen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin.

Timeline

Start
2016-02-27
Primary completion
2017-08-10
Completion
2018-05-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Evolocumab Monoclonal antibody 140 mg Subcutaneous
Subject Evolocumab Monoclonal antibody 420 mg Subcutaneous
Comparator Ezetimibe Unknown 10 mg Oral

Indications