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

PHASE3CompletedINTERVENTIONAL
Enrollment

141

Participants

Timeline

Start Date

January 27, 2021

Primary Completion Date

November 9, 2023

Study Completion Date

November 27, 2024

Conditions
Familial Hypercholesterolemia - Heterozygous
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 subcutaneous injection)

Trial Locations (59)

1000

University Medical Centre Ljubljana, Div. of Pediatric Dept. of Endocrinology, Diabetes and Metabolic Diseases, Ljubljana

1211

Novartis Investigative Site, Geneva

7130

Novartis Investigative Site, Somerset West

7623

Novartis Investigative Site, Pécs

7925

Novartis Investigative Site, Cape Town

9301

Novartis Investigative Site, Bloemfontein

10029

Icahn School of Medicine at Mount Sinai, New York

11217

Taipei Veterans General Hospital, Taipei

12808

Novartis Investigative Site, Prague

14004

Hospital Reina Sofia, Córdoba

15001

Hospital Abente y Lago, A Coruña

15224

Childrens Hospital Pittsburgh of UPMC, Pittsburgh

18547

Metropolitan Hospital, Athens

20162

Novartis Investigative Site, Milan

22060

Far Eastern Memorial Hospital, New Taipei City

22110

Novartis Investigative Site, Irbid

25030

Novartis Investigative Site, Besançon

27157

Wake Forest U of Health Sciences, Winston-Salem

29010

Hospital Virgen de la Vcitoria, Málaga

31008

Novartis Investigative Site, Pamplona

31059

Novartis Investigative Site, Toulouse

33011

Hospital Central de Asturias, Oviedo

34098

Novartis Investigative Site, Istanbul

35100

Novartis Investigative Site, Izmir

41124

Novartis Investigative Site, Modena

47000

UiTM Sungai Buloh, Sungai Buloh

52621

Lipids Center Sheba Medical Center, Israel, Ramat Gan

60590

KKIM UK Frankfurt/Main, Frankfurt

68305

Universitaetsmedizin Mannheim, Mannheim

69677

Novartis Investigative Site, Bron

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

84113

Primary Children's Medical Center, Salt Lake City

85712

Tucson Medical Center, Tucson

127412

Novartis Investigative Site, Moscow

166830

Hotel Dieu de France Hospital, El Achrafiyé

630090

Institute of Internal Prev. Med., Novosibirsk

650002

Institute of the complex problems of cardiovascular disease, Kemerovo

9112001

Lipid Research, Jerusalem

60430275

Unidade de pesquisa clinica - Hospital Universitario Walter Cantidio, Fortaleza

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

P3600

Novartis Investigative Site, Formosa

90430-001

Nucleo de Pesquisa Clinica do Rio Grande do Sul, Porto Alegre

04023-900

Setor de Lípides, Aterosclerose e Biologia, São Paulo

05403 000

Heart Institute (InCOr) HCMFUSP, São Paulo

G1V 4W2

Novartis Investigative Site, Québec

150 06

Novartis Investigative Site, Prague

455 00

University General Hospital of Ioannina, Ioannina

115 27

Hippokrateion General Hospital of Athens Greece, Athens

00161

Novartis Investigative Site, Roma

00165

Novartis Investigative Site, Roma

3015 GD

Novartis Investigative Site, Rotterdam

1105 AZ

Novartis Investigative Site, Amsterdam

0514

Novartis Investigative Site, Oslo

80 952

Novartis Investigative Site, Gdansk

93-338

Novartis Investigative Site, Lodz

058 01

Novartis Investigative Site, Poprad

01330

Novartis Investigative Site, Adana

06500

Gazi University Medical Faculty, Ankara

UB9 6JH

Novartis Investigative Site, Middlesex

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY