An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

September 15, 2016

Primary Completion Date

September 13, 2018

Study Completion Date

February 22, 2019

Conditions
Hypercholesterolaemia
Interventions
DRUG

alirocumab SAR236553 (REGN727)

Pharmaceutical form: solution Route of administration: subcutaneous injection

DRUG

statins

Pharmaceutical form: tablet Route of administration: oral

DRUG

ezetimibe

Pharmaceutical form:tablet Route of administration: oral

DRUG

cholestyramine

Pharmaceutical form:tablet Route of administration: oral

DRUG

fenofibrate

Pharmaceutical form: tablet Route of administration: oral

DRUG

omega-3 fatty acids

Pharmaceutical form: tablet Route of administration: oral

DRUG

nicotinic acid

Pharmaceutical form: tablet Route of administration: oral

Trial Locations (16)

7500

Investigational Site Number 7100001, Parow

15001

Investigational Site Number 7240004, A Coruña

15006

Investigational Site Number 2030003, Praha 5 - Motol

28009

Investigational Site Number 7240001, Madrid

28204

Investigational Site Number 8400005, Charlotte

45229

Investigational Site Number 8400001, Cincinnati

62500

Investigational Site Number 2030001, Brno

63110

Investigational Site Number 8400002, St Louis

69677

Investigational Site Number 2500001, Bron

76275

Investigational Site Number 2030002, Zlín

194100

Investigational Site Number 6430004, Saint Petersburg

650002

Investigational Site Number 6430001, Kemerovo

G1V 4W2

Investigational Site Number 1240001, Québec

1105AZ

Investigational Site Number 5280001, Amsterdam

Unknown

Investigational Site Number 5780001, Oslo

171 76

Investigational Site Number 7520001, Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT02890992 - An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia | Biotech Hunter | Biotech Hunter