Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders

Completed · Phase 3 · Has a placebo group

Conditions studied: Heterozygous Familial Hypercholesterolemia

In brief

A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.

Key facts

Study ID

NCT02392559

Run by

Amgen

People needed

158

Starts

2016-03-24

Expected to finish

2019-11-25

Last updated by the study team

2022-11-08

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 10 to ≤ 17 years of age (before 18th birthday)
• Diagnosis of heterozygous familial hypercholesterolemia
• On an approved statin with stable optimized dose for ≥ 4 weeks
• Other lipid-lowering therapy stable for ≥ 4 weeks (fibrates must be stable for ≥ 6 weeks)
• Fasting LDL-C ≥ 130 mg/dL (3.4 mmol/L)
• Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

You may not qualify if…

• Type 1 diabetes, or type 2 diabetes that is or poorly controlled
• Uncontrolled hyperthyroidism or hypothyroidism
• Cholesterylester transfer protein (CETP) inhibitor in the last 12 months, or mipomersen or lomitapide in the last 5 months
• Previously received evolocumab or any other investigational therapy to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9).
• Lipid apheresis within the last 12 weeks prior to screening.
• Homozygous familial hypercholesterolemia

Where it is running

• Research Site — Wilmington, Delaware, United States
• Research Site — Iowa City, Iowa, United States
• Research Site — Towson, Maryland, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — The Bronx, New York, United States
• Research Site — Asheville, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Salt Lake City, Utah, United States
• Research Site — Morgantown, West Virginia, United States
• Research Site — Camperdown, New South Wales, Australia
• Research Site — Feldkirch, Austria
• Research Site — Salzburg, Austria
• Research Site — Vienna, Austria
• Research Site — Brussels, Belgium
• Research Site — La Louvière, Belgium
• Research Site — Leuven, Belgium
• Research Site — Fortaleza, Ceará, Brazil
• Research Site — Vitória, Espírito Santo, Brazil
• Research Site — Brasília, Federal District, Brazil
• Research Site — São Paulo, Brazil
• Research Site — São Paulo, Brazil
• Research Site — Chicoutimi, Quebec, Canada
• Research Site — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

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