NCT04659863View on ClinicalTrials.gov

Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia

PHASE3CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

February 16, 2021

Primary Completion Date

October 30, 2023

Study Completion Date

November 18, 2024

Conditions
Familial Hypercholesterolemia - Homozygous
Interventions
DRUG

Inclisiran

Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL solution for subcutaneous injection

DRUG

Placebo

Sterile normal saline (0.9% sodium chloride in water for injection) for subcutaneous injection

Trial Locations (11)

18547

Metropolitan Hospital, Athens

33434

Excel Medical Clinical Trials LLC, Boca Raton

34098

Novartis Investigative Site, Istanbul

35100

Novartis Investigative Site, Izmir

59100

Novartis Investigative Site, Kuala Lumpur

69677

Novartis Investigative Site, Bron

166830

Hotel Dieu de France Hospital, El Achrafiyé

G1V 4W2

Novartis Investigative Site, Québec

455 00

University General Hospital of Ioannina, Ioannina

1107 2020

American University of Beirut Medical Center, Beirut

1105 AZ

Novartis Investigative Site, Amsterdam

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY