Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

Amgen160 enrolled

Overview

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

Hyperlipidemia

Interventions

EvolocumabBIOLOGICAL

Administered by subcutaneous injection

EzetimibeDRUG

Administered orally once a day

Placebo to EvolocumabOTHER

Administered by subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female ≥ 18 to ≤ 75 years of age * On a statin or a low dose statin with stable dose for at least 4 weeks * Lipid lowering therapy has been stable prior to enrollment * Fasting triglycerides must be \< 400 mg/dL. * Subject not at LDL-C goal Exclusion Criteria: * New York Heart Association (NYHA) III or IV heart failure or known left ventricular ejection fraction \< 30% * Uncontrolled cardiac arrhythmia * Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization * Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c \> 8.5%) * Uncontrolled hypertension

Locations (42)

Outcomes

Primary Outcomes

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

LDL-C was measured using ultracentrifugation. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.

Time frame: Baseline and Week 12

Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe

LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.

Time frame: Baseline and Week 12

Secondary Outcomes

Change From Baseline in LDL-C at Week 12

LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.

Time frame: Baseline and Week 12

Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe

LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.

Time frame: Baseline and Week 12

Percent Change From Baseline in Non-HDL-C at Week 12

LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.

Time frame: Baseline and Week 12

Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe

Data from ClinicalTrials.gov

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Research Site

Anaheim, California, United States

Research Site

Mission Viejo, California, United States

Research Site

Westlake Village, California, United States

Research Site

Atlanta, Georgia, United States

Research Site

Atlanta, Georgia, United States

Research Site

Savannah, Georgia, United States

Research Site

Auburn, Maine, United States

Research Site

Chevy Chase, Maryland, United States

Research Site

Butte, Montana, United States

Research Site

Henderson, Nevada, United States

...and 32 more locations

LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.

Time frame: Baseline and Week 12

Percent Change From Baseline in Apolipoprotein B at Week 12

LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.

Time frame: Baseline and Week 12

Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe

LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe) and stratification factors as covariates.

Time frame: Baseline and Week 12

Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12

LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.

Time frame: Baseline and Week 12

Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe

LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.

Time frame: Baseline and Week 12

Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12

LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.

Time frame: Baseline and Week 12

Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe

LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.

Time frame: Baseline and Week 12