Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

Amgen331 enrolled

Overview

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

331

Conditions

Hyperlipidemia

Interventions

EvolocumabBIOLOGICAL

Administered by subcutaneous injection

PlaceboDRUG

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 * Diagnosis of heterozygous familial hypercholesterolemia * On a stable dose of an approved statin and lipid regulating medication * Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) * Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) Exclusion Criteria: * Homozygous familial hypercholesterolemia * LDL or plasma apheresis * 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 (39)

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-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

Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12

Data from ClinicalTrials.gov

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Research Site

Scottsdale, Arizona, United States

Research Site

Cincinnati, Ohio, United States

Research Site

Camperdown, New South Wales, Australia

Research Site

Perth, Western Australia, Australia

Research Site

Vancouver, British Columbia, Canada

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London, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Montreal, Quebec, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Bron, France

...and 29 more locations