Phase
Condition
Congestive Heart Failure
Heart Failure
Chest Pain
Treatment
sacubitril/valsartan
Clinical Study ID
Ages 1-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed informed consent
On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safetyissue
Exclusion
Exclusion Criteria:
Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF orpermanently discontinued study drug in PANORMA-HF Part 2
Use of investigational drugs within 5 half-lives of enrollment or within 30 days (longer duration); with the exception of PANORAMA-HF study drug (requires >/=36-hourwashout before baseline visit)
History of hypersensitivity or allergy to study treatment, its excipients or drugsof similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspectedcontraindications to sacubitril/valsartan
Renal vascular hypertension (including renal artery stenosis)
Significant renal estimated glomerular filtration rate disorder (eGFR calculatedusing modified Schwartz formula <30% mean GFR for age); hepatic disorder (serumaspartate aminotransferase or alanine aminotransferase > 3 times upper limit ofnormal); gastrointestinal disorder or biliary disorder
History of angioedema
Parents or legal guardians of subject who do not give consent or allow the child togive assent, or inability of patient or parents/legal guardians to followinstructions or comply with follow-up procedures
Any medical condition(s) that may put the patient at risk in the investigator'sopinion or that the investigator deems unsuitable for the study
Other protocol defined inclusion/exclusion criteria may apply
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Ciudad de Salta, Provincia De Salta A4406BPF
ArgentinaSite Not Available
Novartis Investigative Site
Innsbruck, 6020
AustriaSite Not Available
Novartis Investigative Site
Sofia, 1309
BulgariaSite Not Available
Novartis Investigative Site
Edmonton, Alberta T6G 1C9
CanadaSite Not Available
Novartis Investigative Site
Toronto, Ontario M5G 1X8
CanadaSite Not Available
Novartis Investigative Site
Zagreb, 10000
CroatiaSite Not Available
Novartis Investigative Site
Praha 5, 150 06
CzechiaSite Not Available
Novartis Investigative Site
Helsinki, 00290
FinlandSite Not Available
Novartis Investigative Site
Paris, 75015
FranceSite Not Available
Novartis Investigative Site
Paris 15, 75015
FranceSite Not Available
Novartis Investigative Site
Paris cedex 15, 75015
FranceSite Not Available
Novartis Investigative Site
Berlin, 13353
GermanySite Not Available
Novartis Investigative Site
Erlangen, 91054
GermanySite Not Available
Novartis Investigative Site
Freiburg, 79106
GermanySite Not Available
Novartis Investigative Site
Heidelberg, 69120
GermanySite Not Available
Novartis Investigative Site
Stuttgart, 70174
GermanySite Not Available
Novartis Investigative Site
Budapest, H 1096
HungarySite Not Available
Novartis Investigative Site
New Delhi, Delhi 110076
IndiaSite Not Available
Novartis Investigative Site
Ahmedabad, Gujarat 380 060
IndiaSite Not Available
Novartis Investigative Site
Kochi, Kerala 682041
IndiaSite Not Available
Novartis Investigative Site
Be'er-Sheva, 84101
IsraelSite Not Available
Novartis Investigative Site
Beer Sheva, 84101
IsraelSite Not Available
Novartis Investigative Site
Bergamo, BG 24127
ItalySite Not Available
Novartis Investigative Site
Bologna, BO 40138
ItalySite Not Available
Novartis Investigative Site
Firenze, FI 50132
ItalySite Not Available
Novartis Investigative Site
Milano, MI 20162
ItalySite Not Available
Novartis Investigative Site
Roma, RM 00165
ItalySite Not Available
Novartis Investigative Site
Torino, TO 10126
ItalySite Not Available
Novartis Investigative Site
Napoli, 80131
ItalySite Not Available
Novartis Investigative Site
Obu, Aichi 474 8710
JapanSite Not Available
Novartis Investigative Site
Sapporo city, Hokkaido 060 8648
JapanSite Not Available
Novartis Investigative Site
Omura, Nagasaki 856-8562
JapanSite Not Available
Novartis Investigative Site
Bunkyo ku, Tokyo 113 8655
JapanSite Not Available
Novartis Investigative Site
Setagaya-ku, Tokyo 157-8535
JapanSite Not Available
Novartis Investigative Site
Shinjuku ku, Tokyo 162 8666
JapanSite Not Available
Novartis Investigative Site
Toyama-city, Toyama 930-0194
JapanSite Not Available
Novartis Investigative Site
Saitama, 330 8777
JapanSite Not Available
Novartis Investigative Site
Yangsan Si, Gyeongsangnam Do 50612
Korea, Republic ofSite Not Available
Novartis Investigative Site
Seoul, 03722
Korea, Republic ofSite Not Available
Novartis Investigative Site
Ashrafieh, 166830
LebanonSite Not Available
Novartis Investigative Site
Beirut, 10999
LebanonSite Not Available
Novartis Investigative Site
Warszawa, 04 730
PolandSite Not Available
Novartis Investigative Site
Wroclaw, 51-124
PolandSite Not Available
Novartis Investigative Site
Carnaxide, Lisboa 2799 523
PortugalSite Not Available
Novartis Investigative Site
Coimbra, 3000 075
PortugalSite Not Available
Novartis Investigative Site
Lisboa, 1169 024
PortugalSite Not Available
Novartis Investigative Site
Moscow, 125412
Russian FederationSite Not Available
Novartis Investigative Site
Saint Petersburg, 197341
Russian FederationSite Not Available
Novartis Investigative Site
Singapore, 229899
SingaporeSite Not Available
Novartis Investigative Site
Soweto, Gauteng 2013
South AfricaSite Not Available
Novartis Investigative Site
Cordoba, Andalucia 14004
SpainSite Not Available
Novartis Investigative Site
Esplugues De Llobregat, Barcelona 08950
SpainSite Not Available
Novartis Investigative Site
Barcelona, Catalunya 08035
SpainSite Not Available
Novartis Investigative Site
Madrid, 28009
SpainSite Not Available
Novartis Investigative Site
Lausanne, 1011
SwitzerlandSite Not Available
Novartis Investigative Site
Tainan, 70403
TaiwanSite Not Available
Novartis Investigative Site
Taipei, 10041
TaiwanSite Not Available
Novartis Investigative Site
Bangkoknoi, Bangkok 10700
ThailandSite Not Available
Novartis Investigative Site
Bangkok, 10400
ThailandSite Not Available
Novartis Investigative Site
Ankara, 06490
TurkeySite Not Available
Novartis Investigative Site
Izmir, 35040
TurkeySite Not Available
Novartis Investigative Site
Konak-Izmir, 35210
TurkeySite Not Available
Novartis Investigative Site
Konak/Izmir, 35210
TurkeySite Not Available
Novartis Investigative Site
Loma Linda, California 92354
United StatesSite Not Available
Novartis Investigative Site
Los Angeles, California 90095
United StatesSite Not Available
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United StatesSite Not Available
Novartis Investigative Site
Palo Alto, California 94304
United StatesSite Not Available
Novartis Investigative Site
Hollywood, Florida 33021
United StatesSite Not Available
All Childrens Hospital
Saint Petersburg, Florida 33701
United StatesSite Not Available
Novartis Investigative Site
Saint Petersburg, Florida 33701
United StatesSite Not Available
Childrens Healthcare Of Atlanta
Atlanta, Georgia 30322
United StatesSite Not Available
Novartis Investigative Site
Atlanta, Georgia 30322
United StatesSite Not Available
Novartis Investigative Site
Indianapolis, Indiana 46202
United StatesSite Not Available
Riley Hospital for Children
Indianapolis, Indiana 46202
United StatesSite Not Available
Childrens Hospital Boston CAFQ056B2252
Boston, Massachusetts 02115
United StatesSite Not Available
Novartis Investigative Site
Boston, Massachusetts 02115
United StatesSite Not Available
CS Mott Children's Hospital CLCZ696B2319
Ann Arbor, Michigan 48109-5238
United StatesSite Not Available
Novartis Investigative Site
Ann Arbor, Michigan 48109-5238
United StatesSite Not Available
Novartis Investigative Site
Minneapolis, Minnesota 55455
United StatesSite Not Available
University of Minnesota Cardiovascular Clinical Trials Ctr CLCZ696B2319
Minneapolis, Minnesota 55455
United StatesSite Not Available
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Novartis Investigative Site
Rochester, Minnesota 55905
United StatesSite Not Available
Novartis Investigative Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Col Uni Med Center New York Presby CDEB025A2306
New York, New York 10032
United StatesSite Not Available
Novartis Investigative Site
New York, New York 10032
United StatesSite Not Available
Novartis Investigative Site
Charlotte, North Carolina 28203
United StatesSite Not Available
Sanger Heart and Vascular Institute
Charlotte, North Carolina 28203
United StatesSite Not Available
Novartis Investigative Site
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Novartis Investigative Site
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
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