TAUSSIG

Trial name or title	TAUSSIG
Methods	Open‐label parallel randomised controlled trial
Participants	Inclusion criteria Participated in a qualifying evolocumab (AMG145) parent protocol OR Have a diagnosis of familial hypercholesterolaemia AND Males and females ≥ 12 to ≤ 80 years of age Stable low‐fat diet and lipid‐lowering therapies for ≥ 4 weeks Low‐density lipoprotein cholesterol (LDL‐C) ≥ 130 mg/dL (3.4 mmol/L) for people without diagnosed CHD/CHD risk equivalent OR LDL‐C ≥ 100 mg/dL (2.6 mmol/L) for those with diagnosed CHD or CHD risk equivalent OR people given apheresis with no LDL‐C entry requirement Fasting triglycerides < 400 mg/dL (4.5 mmol/L) Body weight ≥ 40 kg at screening for those younger than 18 years Exclusion criteria New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30% Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of screening Planned cardiac surgery or revascularisation Uncontrolled cardiac arrhythmia Uncontrolled hypertension
Interventions	1 monthly dose of evolocumab compared with 2 monthly dosages of evolocumab
Outcomes	Incidence of treatment‐emergent adverse events
Starting date	June 2015
Contact information
Notes	Amgen