Heart Failure Clinical Trial
CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF
Summary
The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.
Eligibility Criteria
Inclusion Criteria:
Signed informed consent
On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue
Exclusion Criteria:
Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or permanently 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-hour washout before baseline visit)
History of hypersensitivity or allergy to study treatment, its excipients or drugs of similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected contraindications to sacubitril/valsartan
Renal vascular hypertension (including renal artery stenosis)
Significant renal estimated glomerular filtration rate disorder (eGFR calculated using modified Schwartz formula <30% mean GFR for age); hepatic disorder (serum aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal); gastrointestinal disorder or biliary disorder
History of angioedema
Parents or legal guardians of subject who do not give consent or allow the child to give assent, or inability of patient or parents/legal guardians to follow instructions or comply with follow-up procedures
Any medical condition(s) that may put the patient at risk in the investigator's opinion or that the investigator deems unsuitable for the study
Other protocol defined inclusion/exclusion criteria may apply
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There are 79 Locations for this study
Loma Linda California, 92354, United States
Los Angeles California, 90095, United States
Palo Alto California, 94304, United States
Saint Petersburg Florida, 33701, United States
Atlanta Georgia, 30322, United States
Indianapolis Indiana, 46202, United States
Boston Massachusetts, 02115, United States
Ann Arbor Michigan, 48109, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
New York New York, 10032, United States
Charlotte North Carolina, 28203, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15224, United States
Ciudad de Salta Provincia De Salta, A4406, Argentina
Innsbruck , 6020, Austria
Sofia , 1309, Bulgaria
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G 1, Canada
Zagreb , 10000, Croatia
Praha 5 , 150 0, Czechia
Helsinki , 00290, Finland
Paris , 75015, France
Berlin , 13353, Germany
Erlangen , 91054, Germany
Freiburg , 79106, Germany
Heidelberg , 69120, Germany
Stuttgart , 70174, Germany
Budapest , H 109, Hungary
New Delhi Delhi, 11007, India
Ahmedabad Gujarat, 380 0, India
Kochi Kerala, 68204, India
New Delhi , 11002, India
Be'er-Sheva , 84101, Israel
Bergamo BG, 24127, Italy
Bologna BO, 40138, Italy
Firenze FI, 50132, Italy
Milano MI, 20162, Italy
Roma RM, 00165, Italy
Torino TO, 10126, Italy
Napoli , 80131, Italy
Obu Aichi, 474 8, Japan
Sapporo city Hokkaido, 060 8, Japan
Omura Nagasaki, 856-8, Japan
Bunkyo ku Tokyo, 113 8, Japan
Setagaya-ku Tokyo, 157-8, Japan
Shinjuku ku Tokyo, 162 8, Japan
Toyama-city Toyama, 930-0, Japan
Saitama , 330 8, Japan
Yangsan Si Gyeongsangnam Do, 50612, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Ashrafieh , 16683, Lebanon
Beirut , 10999, Lebanon
Warszawa , 04 73, Poland
Wroclaw , 51-12, Poland
Carnaxide Lisboa, 2799 , Portugal
Coimbra , 3000 , Portugal
Lisboa , 1169 , Portugal
Moscow , 12541, Russian Federation
Saint Petersburg , 19734, Russian Federation
Singapore , 11926, Singapore
Singapore , 22989, Singapore
Soweto Gauteng, 2013, South Africa
Cordoba Andalucia, 14004, Spain
Barcelona Cataluna, 08950, Spain
Barcelona Catalunya, 08035, Spain
Madrid , 28009, Spain
Madrid , 28046, Spain
Lausanne , 1011, Switzerland
Tainan , 70403, Taiwan
Taipei , 10041, Taiwan
Bangkoknoi Bangkok, 10700, Thailand
Bangkok , 10400, Thailand
Ankara , 06490, Turkey
Izmir , 35040, Turkey
Konak-Izmir , 35210, Turkey
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