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 |
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.
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
We found this trial at
44
sites
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