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

PHASE3CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 31, 2018

Primary Completion Date

February 17, 2020

Study Completion Date

February 17, 2020

Conditions
Hypercholesterolemia
Interventions
DRUG

Alirocumab SAR236553 (REGN727)

"Pharmaceutical form: solution for injection in pre-filled syringe,~Route of administration: subcutaneous (SC)"

DRUG

Atorvastatin

"Pharmaceutical form: tablet,~Route of administration: oral"

DRUG

Simvastatin

"Pharmaceutical form: tablet,~Route of administration: oral"

DRUG

Fluvastatin

"Pharmaceutical form: capsule,~Route of administration: oral"

DRUG

Pravastatin

"Pharmaceutical form: tablet,~Route of administration: oral"

DRUG

Lovastatin

"Pharmaceutical form: tablet,~Route of administration: oral"

DRUG

Rosuvastatin

"Pharmaceutical form: tablet,~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"

Trial Locations (10)

112

Investigational Site Number 1580001, Taipei

1000

Investigational Site Number 7050001, Ljubljana

8800

Investigational Site Number 2080001, Viborg

15001

Investigational Site Number 7240001, A Coruña

35040

Investigational Site Number 7920001, Izmir

68000

Investigational Site Number 4840006, Oaxaca City

650002

Investigational Site Number 6430002, Kemerovo

05403-000

Investigational Site Number 0760001, São Paulo

G1V 4W2

Investigational Site Number 1240001, Québec

1105AZ

Investigational Site Number 5280001, Amsterdam

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY