LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy

Amgen631 enrolled

Overview

To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

631

Conditions

Hyperlipidemia

Interventions

EvolocumabBIOLOGICAL

Administered by subcutaneous injection

Placebo to EvolocumabOTHER

Administered by subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female ≥ 18 to ≤ 80 years of age * On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks * Fasting LDL-C ≥ 85 mg/dL * Fasting triglycerides ≤ 400 mg/dL Exclusion Criteria: * 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 (Glycosyated Hemoglobin (HbA1c) \> 8.5%) * Uncontrolled hypertension * New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction \< 30% * Uncontrolled cardiac arrhythmia

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