Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 11/30/2018 |
| Start Date: | July 6, 2011 |
| End Date: | March 2, 2012 |
A Randomized, Placebo- and Ezetimibe-controlled, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Hypercholesterolemic Subjects With a 10-year Framingham Risk Score of 10% or Less
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG
145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change
from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change
from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
Inclusion Criteria:
- Male or female ≥ 18 to ≤ 75 years of age
- Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and < 190 mg/dL
- Framingham risk score of 10% or less
- Fasting triglycerides < 400 mg/dL
Exclusion Criteria:
- History of coronary heart disease
- New York Heart Association (NYHA) II - IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
We found this trial at
38
sites
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