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Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study | Clinical Trials | Clareo Health

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Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Subject With Heterozygous Familial Hypercholesterolemia

NCT01375751•Amgen

View on ClinicalTrials.gov

Summary

The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in adults with heterozygous familial hypercholesterolemia (HeFH).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female ≥ 18 to ≤ 75 years of age
•Diagnosis of heterozygous familial hypercholesterolemia by having met the diagnostic criteria outlined by the Simon Broome Register Group (Scientific Steering Committee 1991)
•On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
•Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL
•Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria

•Homozygous familial hypercholesterolemia
•Low-Density Lipoprotein (LDL) or plasma apheresis within 12 months prior to randomization
•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; newly diagnosed or poorly controlled type 2 diabetes (HbA1c \> 8.5%)
•Uncontrolled hypertension

Key Dates

Start Date

August 2, 2011

Primary Completion Date

May 16, 2012

Completion Date

May 16, 2012

Last Updated

November 15, 2022

Enrollment

168

ACTUAL participants

Conditions

Hypercholesterolemia, Familial

Interventions

Evolocumab

BIOLOGICAL

Placebo

BIOLOGICAL

Screening for Familial Hypercholesterolemia in Children

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ACTIVE_NOT_RECRUITINGNA

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Hypercholesterolemia, FamilialHypercholesterolemia, Familial, 1+24 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study

Inclusion Criteria

Exclusion Criteria

Screening for Familial Hypercholesterolemia in Children

Genetic Testing and Motivational Counseling for FH

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