Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:4/6/2019
Start Date:January 21, 2013

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A Double-blind, Randomized, Placebo and Ezetimibe-controlled, Multicenter Study to Evaluate Safety and Efficacy of Lipid Lowering Monotherapy With AMG 145 in Subjects With a 10-Year Framingham Risk Score of 10% or Less

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC)
monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on
percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a
10-year Framingham risk score of 10% or less.


Inclusion Criteria:

- Male or female ≥ 18 to ≤ 80 years of age

- National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III)
Framingham risk score of 10% or less

- Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and <190 mg/dL

- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

- History of coronary heart disease

- New York Heart Association (NYHA) III or IV heart failure

- Uncontrolled cardiac arrhythmia

- Uncontrolled hypertension

- Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)

- Uncontrolled hypothyroidism or hyperthyroidism
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