An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

PHASE3CompletedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

May 31, 2018

Primary Completion Date

January 14, 2021

Study Completion Date

August 5, 2022

Conditions
Hypercholesterolaemia
Interventions
DRUG

Alirocumab SAR236553 (REGN727)

Pharmaceutical form:solution Route of administration: subcutaneous injection

DRUG

Rosuvastatin

Pharmaceutical form:tablet Route of administration: oral

DRUG

Atorvastatin

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Simvastatin

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Pravastatin

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Lovastatin

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Fluvastatin

Pharmaceutical form:Capsule Route of administration: Oral

DRUG

Ezetimibe

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Cholestyramine

Pharmaceutical form:oral suspension Route of administration: oral

DRUG

Nicotinic acid

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Fenofibrate

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Omega-3 fatty acids

Pharmaceutical form:capsule Route of administration: oral

DRUG

Placebo

Pharmaceutical form:solution Route of administration: subcutaneous injection

Trial Locations (43)

112

Investigational Site Number :1580001, Taipei

1000

Investigational Site Number :7050001, Ljubljana

1090

Investigational Site Number :0400001, Vienna

1094

Investigational Site Number :3480001, Budapest

2100

Investigational Site Number :2080001, Copenhagen

4002

Investigational Site Number :1000002, Plovdiv

7500

Investigational Site Number :7100002, Parow

15001

Investigational Site Number :7240002, A Coruña

15006

Investigational Site Number :2030001, Praha 5 - Motol

20142

Investigational Site Number :3800003, Milan

28204

Presbyterian Novant Heart & Wellness-Site Number:8400002, Charlotte

31008

Investigational Site Number :7240003, Pamplona

33434

Excel Medical Clinical Trials, LLC-Site Number:8400001, Boca Raton

35040

Investigational Site Number :7920001, Izmir

37232

Vanderbilt University-Site Number:8400003, Nashville

44093

Investigational Site Number :2500002, Nantes

44100

Investigational Site Number :4840008, Guadalajara

45229

Cincinnati Children's Hospital Medical Center-Site Number:8400005, Cincinnati

62500

Investigational Site Number :2030002, Brno

63110

Washington University School of Medicine-Site Number:8400006, St Louis

68000

Investigational Site Number :4840007, Oaxaca City

69500

Investigational Site Number :2500001, Bron

90127

Investigational Site Number :3800001, Palermo

115446

Investigational Site Number :6430004, Moscow

420138

Investigational Site Number :6430006, Kazan'

450083

Investigational Site Number :6430002, Ufa

650002

Investigational Site Number :6430001, Kemerovo

C1245AAM

Investigational Site Number :0320001, Buenos Aires

91350-200

Investigational Site Number :0760004, Porto Alegre

05403-900

Investigational Site Number :0760001, São Paulo

G1V 4W2

Investigational Site Number :1240001, Québec

00029

Investigational Site Number :2460001, HUS

Unknown

Investigational Site Number :3800002, Roma

Investigational Site Number :4220001, Beirut

Investigational Site Number :5780001, Oslo

Investigational Site Number :6160002, Gdansk

00000

Investigational Site Number :4220003, Room Hospital Street, Achrafie

1105AZ

Investigational Site Number :5280001, Amsterdam

93-338

Investigational Site Number :6160001, Lodz

08916

Investigational Site Number :7240004, Badalona

08208

Investigational Site Number :7240001, Barcelona

171 76

Investigational Site Number :7520001, Stockholm

06500

Investigational Site Number :7920002, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY