hypercholesterolaemia
Conditions
Interventions
Treatment with AMG 145 or placebo.
Sponsors
Amgen BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Females (non-child-bearing potential or adequate contraception) and males 18-75 years of age. * Heterozygous familial hypercholesterolemia by having met the diagnostic criteria outlined by the Simon Broome Register Group (Scientific Steering Committee 1991), see protocol for details. * On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks before LDL-C screening. * Fasting LDL-C * 100 mg/dL by central laboratory at screening. * Fasting triglycerides * 400 mg/dL by central laboratory at screening.
Exclusion criteria
Exclusion criteria: * LDL or plasma apheresis within 12 months prior to randomization. * NYHA III or IV heart failure, or known left ventricular ejection fraction 8.5%). * Uncontrolled hypertension. * Active infection. * Pregnancy, inadequate contraception, breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in LDL-C at week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, Absolute change from baseline in LDL-C at week 12, Percent change from baseline in non-HDL-C at week 12, Percent change from baseline in ApoB at week 12, Percent change from baseline in the total cholesterol/HDL-C ratio at week 12, Percent change from baseline in ApoB/ApoA1 ratio at week 12. | — |
Countries
Netherlands
Outcome results
None listed