Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

Amgen307 enrolled

Overview

The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

307

Conditions

Hyperlipidemia

Interventions

EvolocumabBIOLOGICAL

Subcutaneous injection

Placebo to EvolocumabDRUG

Subcutaneous injection

EzetimibeDRUG

Tablet for oral administration

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 * Not on a statin or on a low dose statin with stable dose for at least 4 weeks * History of intolerance to at least 2 statins * Subject not at LDL-C goal * Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks. * Fasting triglycerides ≤ 400 mg/dL Exclusion Criteria: * New York Heart Association (NYHA) III or IV heart failure * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Type 1 diabetes, poorly controlled type 2 diabetes * Uncontrolled hypothyroidism or hyperthyroidism

Locations (58)

Outcomes

Primary Outcomes

Percent Change From Baseline in 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 With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)

Time frame: Weeks 10 and 12

Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12

Time frame: Week 12

Percent Change From Baseline in 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

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

Data from ClinicalTrials.gov

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Tablet for oral administration

Research Site

Carmichael, California, United States

Research Site

Los Angeles, California, United States

Research Site

Mission Viejo, California, United States

Research Site

Thousand Oaks, 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

Traverse City, Michigan, United States

Research Site

St Louis, Missouri, United States

...and 48 more locations

Time frame: Baseline and Weeks 10 and 12

Percent Change From Baseline in the 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 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 High-Density Lipoprotein Cholesterol (HDL-C) at Week 12

Time frame: Baseline and Week 12

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

Time frame: Baseline and Weeks 10 and 12

Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12

Time frame: Baseline and Week 12