Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2

Amgen615 enrolled

Overview

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

615

Conditions

Hyperlipidemia

Interventions

EvolocumabBIOLOGICAL

Administered by subcutaneous injection

EzetimibeDRUG

Administered orally once a day

Placebo to EvolocumabBIOLOGICAL

Administered by subcutaneous injection

Placebo to Ezetimibe

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female ≥ 18 to ≤ 80 years of age * National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less * Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and \<190 mg/dL * Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) Exclusion Criteria: * History of coronary heart disease * New York Heart Association (NYHA) III or IV heart failure * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes) * Uncontrolled hypothyroidism or hyperthyroidism

Locations (83)

Outcomes

Primary Outcomes

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

Time frame: Baseline and Week 12

Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

Time frame: Baseline and Weeks 10 and 12

Secondary Outcomes

Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

Time frame: Baseline and Weeks 10 and 12

Change From Baseline in LDL-C at Week 12

Time frame: Baseline and Week 12

Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL

Time frame: Weeks 10 and 12

Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12

Time frame: Week 12

Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12

Time frame: Baseline and Weeks 10 and 12

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

Time frame: Baseline and Week 12

Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12

Time frame: Baseline and Weeks 10 and 12

Percent Change From Baseline in Apolipoprotein B at Week 12

Time frame: Baseline and Week 12

Data from ClinicalTrials.gov

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Administered orally once daily

Research Site

Birmingham, Alabama, United States

Research Site

Chandler, Arizona, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Carmichael, California, United States

Research Site

Encinitas, California, United States

Research Site

San Diego, California, United States

Research Site

Tustin, California, United States

Research Site

Jacksonville, Florida, United States

Research Site

Jacksonville, Florida, United States

Research Site

Miami, Florida, United States

...and 73 more locations

Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12

Time frame: Baseline and Weeks 10 and 12

Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12

Time frame: Baseline and Week 12

Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12

Time frame: Baseline and Weeks 10 and 12

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

Time frame: Baseline and Week 12

Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12

Time frame: Baseline and Weeks 10 and 12

Percent Change From Baseline in Lipoprotein (a) at Week 12

Time frame: Baseline and Week 12

Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12

Time frame: Baseline and Weeks 10 and 12

Percent Change From Baseline in Triglycerides at Week 12

Time frame: Baseline and Week 12

Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12

Time frame: Baseline and Weeks 10 and 12

Percent Change From Baseline in VLDL-C at Week 12

Time frame: Baseline and Week 12

Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12

Time frame: Baseline and Weeks 10 and 12

Percent Change From Baseline in HDL-C at Week 12

Time frame: Baseline and Week 12