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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-02

Study Completion Date

2012-05-16

Brief Summary

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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).

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Detailed Description

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Conditions

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Hypercholesterolemia, Familial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

d by subcutaneous injection

Evolocumab 350 mg

Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Evolocumab 420 mg

Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Interventions

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Evolocumab

Administered by subcutaneous injection

Intervention Type BIOLOGICAL

Placebo

d by subcutaneous injection

Intervention Type BIOLOGICAL

Other Intervention Names

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AMG 145 Repatha

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No