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

PHASE3CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

March 24, 2016

Primary Completion Date

November 25, 2019

Study Completion Date

November 25, 2019

Conditions
Heterozygous Familial Hypercholesterolemia
Interventions
DRUG

Evolocumab

Dose of subcutaneous evolocumab every 4 weeks

DRUG

Placebo

Dose of subcutaneous placebo treatment every 4 weeks

Trial Locations (66)

1000

Research Site, Ljubljana

1090

Research Site, Vienna

1094

Research Site, Budapest

1200

Research Site, Brussels

1211

Research Site, Geneva

2050

Research Site, Camperdown

3000

Research Site, Leuven

4153

Research Site, Reinach

5020

Research Site, Salzburg

5021

Research Site, Bergen

6800

Research Site, Feldkirch

7100

Research Site, La Louvière

7505

Research Site, Parow

8011

Research Site, Christchurch

10126

Research Site, Torino

10467

Research Site, The Bronx

11217

Research Site, Taipei

14004

Research Site, Córdoba

15001

Research Site, A Coruña

15224

Research Site, Pittsburgh

16150

Research Site, Kota Bharu

17674

Research Site, Athens

19803

Research Site, Wilmington

21204

Research Site, Towson

26506

Research Site, Morgantown

27003

Research Site, Lugo

28803

Research Site, Asheville

35100

Research Site, Izmir

37212

Research Site, Nashville

41013

Research Site, Seville

45227

Research Site, Cincinnati

52242

Research Site, Iowa City

54642

Research Site, Thessaloniki

55454

Research Site, Minneapolis

56124

Research Site, Pisa

70029

Research Site, Kuopio

84113

Research Site, Salt Lake City

90127

Research Site, Palermo

125412

Research Site, Moscow

191025

Research Site, Saint Petersburg

06032

Research Site, Farmington

60430-270

Research Site, Fortaleza

29055-450

Research Site, Vitória

71625-175

Research Site, Brasília

04040-000

Research Site, São Paulo

05403-000

Research Site, São Paulo

G7H 5H6

Research Site, Chicoutimi

G7H 7K9

Research Site, Chicoutimi

G1V 4W2

Research Site, Québec

080020

Research Site, Barranquilla

Unknown

Research Site, Floridablanca

708 52

Research Site, Ostrava-Poruba

150 06

Research Site, Prague

568 25

Research Site, Svitavy

00029

Research Site, Helsinki

00161

Research Site, Roma

00165

Research Site, Roma

1105 AZ

Research Site, Amsterdam

0586

Research Site, Oslo

80-952

Research Site, Gdansk

4835-044

Research Site, Guimarães

0087

Research Site, Pretoria

08036

Research Site, Barcelona

06500

Research Site, Ankara

B4 6NH

Research Site, Birmingham

WC1N 3JH

Research Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT02392559 - 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 | Biotech Hunter | Biotech Hunter