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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Amgen
Study ID
NCT02624869
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — BIOLOGICAL
    Administered by subcutaneous injection

Study Details

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.

Key Dates

Start date
Sep 10, 2016
Status verified
May 2024
Primary completion
Jun 1, 2021
Completion
Jun 1, 2021

Study Design

Enrollment
163 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab
    Participants receive 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 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. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteThe BronxNew York10467-
Research SiteCincinnatiOhio45227-
Research SiteNashvilleTennessee37212-

Find similar trials in The Bronx, NY

By research site
Research Site· The Bronx, NYResearch Site· Cincinnati, OHResearch Site· Nashville, TN

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