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

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
Amgen
Study ID
NCT02392559
Phase
PHASE3
Status
Completed

Conditions

  • Heterozygous Familial Hypercholesterolemia

Eligibility Criteria

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

Interventions

  • Evolocumab — DRUG
    Dose of subcutaneous evolocumab every 4 weeks
  • Placebo — DRUG
    Dose of subcutaneous placebo treatment every 4 weeks

Study Details

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

Key Dates

Start date
Mar 24, 2016
Status verified
Nov 2022
Primary completion
Nov 25, 2019
Completion
Nov 25, 2019

Study Design

Enrollment
158 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Matching subcutaneous injection every 4 weeks (QM)
  • Experimental: EvoMab 420 mg QM
    Evolocumab subcutaneous injection QM

Primary Outcome Measure

Percent Change From Baseline to Week 24 in LDL-C [ Time Frame: Baseline, Week 24 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Research SiteFarmingtonConnecticut06032-
Research SiteWilmingtonDelaware19803-
Research SiteIowa CityIowa52242-
Research SiteTowsonMaryland21204-
Research SiteMinneapolisMinnesota55454-
Research SiteThe BronxNew York10467-
Research SiteAshevilleNorth Carolina28803-
Research SiteCincinnatiOhio45227-
Research SitePittsburghPennsylvania15224-
Research SiteNashvilleTennessee37212-
Research SiteSalt Lake CityUtah84113-
Research SiteMorgantownWest Virginia26506-

Find similar trials in Farmington, CT

By research site
Research Site· Farmington, CTResearch Site· Wilmington, DEResearch Site· Iowa City, IAResearch Site· Towson, MDResearch Site· Minneapolis, MNResearch Site· The Bronx, NY

Related Studies