Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

393

Participants

Timeline

Start Date

November 3, 2016

Primary Completion Date

January 3, 2022

Study Completion Date

January 3, 2022

Conditions
Pediatric Heart Failure
Interventions
DRUG

LCZ696

LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules)

DRUG

Enalapril

Enalapril tablets: 2.5 mg, 5 mg, 10 mg dosage strengths

DRUG

Placebo of LCZ696

DRUG

Placebo of Enalapril

DRUG

LCZ696

LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules), tablets: 50 mg, 100 mg, 200 mg dosage strengths

Trial Locations (98)

1011

Novartis Investigative Site, Lausanne

1309

Novartis Investigative Site, Sofia

6020

Novartis Investigative Site, Innsbruck

10000

Novartis Investigative Site, Zagreb

10029

Novartis Investigative Site, New York

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

11183

Novartis Investigative Site, Amman

11211

Novartis Investigative Site, Riyadh

13353

Novartis Investigative Site, Berlin

14004

Novartis Investigative Site, Córdoba

15224

Novartis Investigative Site, Pittsburgh

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

32610

Novartis Investigative Site, Gainesville

33136

Novartis Investigative Site, Miami

33600

Novartis Investigative Site, Pessac

33701

Novartis Investigative Site, St. Petersburg

35040

Novartis Investigative Site, Izmir

35128

Novartis Investigative Site, Padua

35210

Novartis Investigative Site, Konak

40138

Novartis Investigative Site, Bologna

44195

Novartis Investigative Site, Cleveland

46202

Novartis Investigative Site, Indianapolis

50132

Novartis Investigative Site, Florence

50612

Novartis Investigative Site, Yangsan

55455

Novartis Investigative Site, Minneapolis

55905

Novartis Investigative Site, Rochester

63110

Novartis Investigative Site, St Louis

69120

Novartis Investigative Site, Heidelberg

70174

Novartis Investigative Site, Stuttgart

75015

Novartis Investigative Site, Paris

75235

Novartis Investigative Site, Dallas

79106

Novartis Investigative Site, Freiburg im Breisgau

80045

Novartis Investigative Site, Aurora

80131

Novartis Investigative Site, Napoli

83301

Novartis Investigative Site, Kaohsiung City

84101

Novartis Investigative Site, Beersheba

84113

Novartis Investigative Site, Salt Lake City

90027

Novartis Investigative Site, Los Angeles

90095

Novartis Investigative Site, Los Angeles

91054

Novartis Investigative Site, Erlangen

92123

Novartis Investigative Site, San Diego

92354

Novartis Investigative Site, Loma Linda

94304

Novartis Investigative Site, Palo Alto

98105

Novartis Investigative Site, Seattle

100037

Novartis Investigative Site, Beijing

110076

Novartis Investigative Site, New Delhi

125412

Novartis Investigative Site, Moscow

166830

Novartis Investigative Site, El Achrafîyé

197341

Novartis Investigative Site, Saint Petersburg

200062

Novartis Investigative Site, Shanghai

200127

Novartis Investigative Site, Shanghai

229899

Novartis Investigative Site, Singapore

510623

Novartis Investigative Site, Guangzhou

682041

Novartis Investigative Site, Kochi

02115

Novartis Investigative Site, Boston

48109-5238

Novartis Investigative Site, Ann Arbor

19104 4399

Novartis Investigative Site, Philadelphia

B1704ETD

Novartis Investigative Site, Ramos Mejía

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

34295 CEDEX 5

Novartis Investigative Site, Montpellier

04289

Novartis Investigative Site, Leipzig

H 1096

Novartis Investigative Site, Budapest

380 060

Novartis Investigative Site, Ahmedabad

110 060

Novartis Investigative Site, New Delhi

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

Unknown

Novartis Investigative Site, Beirut

80-952

Novartis Investigative Site, Gdansk

04 730

Novartis Investigative Site, Warsaw

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

08035

Novartis Investigative Site, Barcelona

08950

Novartis Investigative Site, Barcelona

06490

Novartis Investigative Site, Ankara

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY