Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

PHASE3CompletedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

May 2, 2019

Primary Completion Date

December 29, 2023

Study Completion Date

December 29, 2023

Conditions
Heart Failure
Interventions
DRUG

sacubitril/valsartan

"Target dose 3.1 mg/kg bid~Formulations:~Tablets (50, 100, 200 mg) Granules \[12.5 mg (4 granules), 31.25 mg (10 granules), in capsules\] Liquid (1 mg/ml, 4 mg/ml, prepared from tablets)"

Trial Locations (79)

1011

Novartis Investigative Site, Lausanne

1309

Novartis Investigative Site, Sofia

2013

Novartis Investigative Site, Soweto

6020

Novartis Investigative Site, Innsbruck

10000

Novartis Investigative Site, Zagreb

10032

Novartis Investigative Site, New York

10041

Novartis Investigative Site, Taipei

10126

Novartis Investigative Site, Torino

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkoknoi

10999

Novartis Investigative Site, Beirut

13353

Novartis Investigative Site, Berlin

14004

Novartis Investigative Site, Córdoba

15224

Novartis Investigative Site, Pittsburgh

19104

Novartis Investigative Site, Philadelphia

20162

Novartis Investigative Site, Milan

24127

Novartis Investigative Site, Bergamo

28009

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

28203

Novartis Investigative Site, Charlotte

30322

Novartis Investigative Site, Atlanta

33701

Novartis Investigative Site, St. Petersburg

35040

Novartis Investigative Site, Izmir

35210

Novartis Investigative Site, Konak-Izmir

40138

Novartis Investigative Site, Bologna

46202

Novartis Investigative Site, Indianapolis

50132

Novartis Investigative Site, Florence

50612

Novartis Investigative Site, Yangsan

55455

Novartis Investigative Site, Minneapolis

55905

Mayo Clinic - Rochester, Rochester

63110

Novartis Investigative Site, St Louis

69120

Novartis Investigative Site, Heidelberg

70174

Novartis Investigative Site, Stuttgart

70403

Novartis Investigative Site, Tainan City

75015

Novartis Investigative Site, Paris

79106

Novartis Investigative Site, Freiburg im Breisgau

80131

Novartis Investigative Site, Napoli

84101

Novartis Investigative Site, Beersheba

90095

Novartis Investigative Site, Los Angeles

91054

Novartis Investigative Site, Erlangen

92354

Novartis Investigative Site, Loma Linda

94304

Novartis Investigative Site, Palo Alto

110029

Novartis Investigative Site, New Delhi

110076

Novartis Investigative Site, New Delhi

119260

Novartis Investigative Site, Singapore

125412

Novartis Investigative Site, Moscow

166830

Novartis Investigative Site, El Achrafiyé

197341

Novartis Investigative Site, Saint Petersburg

229899

Novartis Investigative Site, Singapore

682041

Novartis Investigative Site, Kochi

02115

Novartis Investigative Site, Boston

48109-5238

Novartis Investigative Site, Ann Arbor

A4406BPF

Novartis Investigative Site, Salta

T6G 1C9

Novartis Investigative Site, Edmonton

M5G 1X8

Novartis Investigative Site, Toronto

150 06

Novartis Investigative Site, Prague

00290

Novartis Investigative Site, Helsinki

H 1096

Novartis Investigative Site, Budapest

380 060

Novartis Investigative Site, Ahmedabad

00165

Novartis Investigative Site, Roma

474 8710

Novartis Investigative Site, Ōbu

060 8648

Novartis Investigative Site, Sapporo

856-8562

Novartis Investigative Site, Ōmura

113 8655

Novartis Investigative Site, Bunkyo Ku

157-8535

Novartis Investigative Site, Setagaya-ku

162 8666

Novartis Investigative Site, Shinjuku Ku

930-0194

Novartis Investigative Site, Toyama

330 8777

Novartis Investigative Site, Saitama

04 730

Novartis Investigative Site, Warsaw

51-124

Novartis Investigative Site, Wroclaw

2799 523

Novartis Investigative Site, Carnaxide

3000 075

Novartis Investigative Site, Coimbra

1169 024

Novartis Investigative Site, Lisbon

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08950

Novartis Investigative Site, Esplugues de Llobregat

08035

Novartis Investigative Site, Barcelona

06490

Novartis Investigative Site, Ankara

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY