Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/8/2019 |
| Start Date: | February 7, 2013 |
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects With Heterozygous Familial Hypercholesterolemia
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously
once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from
baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial
hypercholesterolemia (HeFH).
once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from
baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial
hypercholesterolemia (HeFH).
Inclusion Criteria:
- Male or female ≥ 18 to ≤ 80 years of age
- Diagnosis of heterozygous familial hypercholesterolemia
- On a stable dose of an approved statin and lipid regulating medication
- Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L)
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria:
- Homozygous familial hypercholesterolemia
- LDL or plasma apheresis
- New York Heart Association (NYHA) III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Type 1 diabetes, poorly controlled type 2 diabetes
- Uncontrolled hypothyroidism or hyperthyroidism
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