Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study — DESCARTES  

Hypercholesterolemia Clinical Trial

Official title: A Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Long-Term Tolerability and Durable Efficacy of AMG 145 (Evolocumab) on LDL-C in Hyperlipidemic Subjects

Status Completed

Clinical Trial Summary

To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.

Clinical Trial Description

Eligible participants with screening central laboratory low-density lipoprotein cholesterol (LDL-C) values ≥ 75 mg/dL (1.9 mmol/L) were instructed to follow National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP) Therapeutic Lifestyle Changes (TLC) diet and were assigned to 1 of the following 4 background lipid-lowering therapies for a 4-week stabilization period based upon their screening LDL-C and its distance from the individual's required goal as stipulated by their NCEP ATP III risk category:

1. no drug therapy required - diet alone

2. low dose drug therapy required - diet plus atorvastatin 10 mg orally (PO) once daily (QD)

3. high dose drug therapy required - diet plus atorvastatin 80 mg PO QD

4. maximal drug therapy required - diet plus atorvastatin 80 mg PO QD plus ezetimibe 10 mg PO QD.

If the participant met entry criteria at the end of the lipid stabilization period they were randomized 2:1 to receive evolocumab 420 mg or placebo subcutaneously once a month for 52 weeks in addition to their background therapy. ;

Related Conditions & MeSH terms

• Hypercholesterolemia

• NCT number: NCT01516879
• Study type: Interventional
• Source: Amgen
• Status: Completed
• Phase: Phase 3
• Start date: January 5, 2012
• Completion date: October 14, 2013