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COMPLETEDPHASE2/PHASE3

Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

NCT01588496•Amgen

View on ClinicalTrials.gov

Summary

A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

Detailed Description

Study Masking: Part A: Open Label Part B: Double Blind

Eligibility

Age

12 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females ≥ 12 to ≤ 80 years of age
•Diagnosis of homozygous familial hypercholesterolemia
•Stable lipid-lowering therapies for at least 4 weeks
•LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
•Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
•Bodyweight of ≥ 40 kg at screening.

Exclusion Criteria

•LDL or plasma apheresis within 8 weeks prior to randomization
•New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
•Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of randomization
•Planned cardiac surgery or revascularization
•Uncontrolled cardiac arrhythmia
•Uncontrolled hypertension

Locations (21)

Research Site

New York, New York, United States

Research Site

Cincinnati, Ohio, United States

Research Site

Brussels, Belgium

Research Site

La Louvière, Belgium

Research Site

London, Ontario, Canada

Research Site

Chicoutimi, Quebec, Canada

Research Site

Brno, Czechia

Research Site

Hradec Králové, Czechia

Research Site

Uherské Hradiště, Czechia

Research Site

Dijon, France

Key Dates

Start Date

April 5, 2012

Primary Completion Date

January 31, 2014

Completion Date

January 31, 2014

Last Updated

November 29, 2018

Enrollment

ACTUAL participants

Conditions

Homozygous Familial Hypercholesterolemia

Interventions

Evolocumab

BIOLOGICAL

Placebo

DRUG

The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository

NCT01109368

Homozygous Familial Hypercholesterolemia

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ACTIVE_NOT_RECRUITING

Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia

NCT06832371

Homozygous Familial Hypercholesterolemia (HoFH)Major Adverse Cardiovascular Events (MACE)+1 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 29, 2018Data 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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Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

Inclusion Criteria

Exclusion Criteria

The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository

Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia

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