CompletedPhase 3

Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)

United States, Australia, Austria163 participantsStarted 2016-09-10

Plain-language summary

The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.

Who can participate

Age range10 Years – 17 Years

SexALL

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Inclusion criteria

✓Completed Study 20120123 (NCT02392559) while still on assigned investigational product and did not experience a treatment-related serious adverse event

Exclusion criteria

✕Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s); except Study 20120123

What they're measuring

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks.

Trial details

NCT IDNCT02624869

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-01

Results submitted2021-11-15

View on ClinicalTrials.gov More Familial Hypercholesterolemia trials