NCT01375751
Completed
Phase 2
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Subject With Heterozygous Familial Hypercholesterolemia
ConditionsHypercholesterolemia, Familial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hypercholesterolemia, Familial
- Sponsor
- Amgen
- Enrollment
- 168
- Primary Endpoint
- Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in adults with heterozygous familial hypercholesterolemia (HeFH).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female ≥ 18 to ≤ 75 years of age
- •Diagnosis of heterozygous familial hypercholesterolemia by having met the diagnostic criteria outlined by the Simon Broome Register Group (Scientific Steering Committee 1991)
- •On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
- •Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL
- •Fasting triglycerides ≤ 400 mg/dL
Exclusion Criteria
- •Homozygous familial hypercholesterolemia
- •Low-Density Lipoprotein (LDL) or plasma apheresis within 12 months prior to randomization
- •New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction \< 30%
- •Uncontrolled cardiac arrhythmia
- •Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
- •Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (HbA1c \> 8.5%)
- •Uncontrolled hypertension
Outcomes
Primary Outcomes
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline and Week 12
LDL-C was measured using ultracentrifugation.
Secondary Outcomes
- Absolute Change From Baseline in LDL-C at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Apolipoprotein B at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C) at Week 12(Baseline and Week 12)
- Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Apolipoprotein B /Apolipoprotein A-1 Ratio at Week 12(Baseline and Week 12)
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