A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia
- Conditions
- hypercholesterolemiaelevated cholesterol10027424
- Registration Number
- NL-OMON40135
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
Males and females, >= 12 to <= 80 years of age diagnosed with severe familial
hypercholesterolemia must meet the following criteria in order to participate in this study:
OR: Completed study 20110233 or a qualifying AMG 145 parent protocol, did not experience
a treatment related serious adverse event that led to IP discontinuation, and are still
taking investigational product at the end of that study.
OR: Subjects that have not participated in a qualifying AMG 145 parent protocol must
also meet all of the following inclusion criteria:
- Are on a stable low-fat diet and taking pre-existing lipid-lowering therapies
- Fasting triglycerides <= 400 mg/dL (4.5 mmol/L)
use of Mipomersen or Lomitapide within 5 months of screening; New York Heart Failure
Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%; cardiac
arrhythmia within past 3 months that is not controlled by medication; myocardial infarction,
unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)
or stroke within 3 months of enrollment; planned cardiac surgery or revascularization; systolic
blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg; requiring statin
up-titration within 4 weeks of screening; estimated glomerular filtration rate (eGFR) <
30 ml/min/1.73m2; persistent aspartate aminotransferase (AST) or alanine aminotransferase
(ALT) > 3x ULN, creatine kinase (CK) > 5x ULN without a known cause; known major active
infection, use of CETP inhibitor in the last 12 months prior to LDL-C screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Subject incidence of treatment emergent adverse events</p><br>
- Secondary Outcome Measures
Name Time Method <p> Percent change in LDL-C from baseline at each scheduled visit<br /><br>• Percent change in non-HDL-C from baseline at each scheduled visit<br /><br>• Percent change in ApoB from baseline at each scheduled vist<br /><br>• Percent change in Lp(a) from baseline at each scheduled visit<br /><br>• Percent change in total cholesterol/HDL-C ratio from baseline at each<br /><br>scheduled visit<br /><br>• Percent change in ApoB/ApoA1 ratio from baseline at each scheduled visit</p><br>