Expired Study
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Grandville, Michigan 49418


Purpose:

To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis


Criteria:

Inclusion Criteria: - Male or female, ≥ 18 years of age - Subject has been receiving regular apheresis for LDL-C lowering for at least 3 months immediately prior to lipid screening and has a treatment goal of LDL-C < 100 mg/dL (2.6 mmol/L), and has been receiving LDL-C apheresis during the last ≥ 4 weeks prior to lipid screening at regular QW or Q2W schedule and with no changes in apheresis type - Subject is receiving lipid-lowering pharmacological background therapy which includes a high-intensity statin dose (moderate-intensity statin dose with attestation that a higher dose is not appropriate for the subject) unless the subject has a history of statin intolerance - Lipid-lowering therapy status (ie, any therapy for lowering lipids, including apheresis type and frequency) must be unchanged for ≥ 4 weeks prior to LDL-C screening - Pre-apheresis LDL-C is ≥ 100 mg/dL (≥ 2.6 mmol/L) and ≤ 190 mg/dL (≤ 4.9 mmol/L) at screening - Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) at screening. Exclusion criteria: - Known homozygous familial hypercholesterolemia - Missing any apheresis session is medically contraindicated or inappropriate - Stopping apheresis would be inappropriate in the opinion of the investigator even if LDL-C is controlled to < 100 mg/dL with other therapies - Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization. - Uncontrolled hypertension


NCT ID:

NCT02585895


Primary Contact:

Study Director
MD
Amgen


Backup Contact:

N/A


Location Contact:

Grandville, Michigan 49418
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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