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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

216

Study ID:

NCT03785405

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 79 Locations for this study

See Locations Near You

Novartis Investigative Site
Loma Linda California, 92354, United States
Novartis Investigative Site
Los Angeles California, 90095, United States
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Palo Alto California, 94304, United States
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Saint Petersburg Florida, 33701, United States
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Atlanta Georgia, 30322, United States
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Indianapolis Indiana, 46202, United States
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Boston Massachusetts, 02115, United States
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Ann Arbor Michigan, 48109, United States
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Minneapolis Minnesota, 55455, United States
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Rochester Minnesota, 55905, United States
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Saint Louis Missouri, 63110, United States
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New York New York, 10032, United States
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Charlotte North Carolina, 28203, United States
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Philadelphia Pennsylvania, 19104, United States
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Pittsburgh Pennsylvania, 15224, United States
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Ciudad de Salta Provincia De Salta, A4406, Argentina
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Innsbruck , 6020, Austria
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Sofia , 1309, Bulgaria
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Edmonton Alberta, T6G 1, Canada
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Toronto Ontario, M5G 1, Canada
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Zagreb , 10000, Croatia
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Praha 5 , 150 0, Czechia
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Helsinki , 00290, Finland
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Paris , 75015, France
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Berlin , 13353, Germany
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Erlangen , 91054, Germany
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Freiburg , 79106, Germany
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Heidelberg , 69120, Germany
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Stuttgart , 70174, Germany
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Budapest , H 109, Hungary
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New Delhi Delhi, 11007, India
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Ahmedabad Gujarat, 380 0, India
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Kochi Kerala, 68204, India
Novartis Investigative Site
New Delhi , 11002, India
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Be'er-Sheva , 84101, Israel
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Bergamo BG, 24127, Italy
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Bologna BO, 40138, Italy
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Firenze FI, 50132, Italy
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Milano MI, 20162, Italy
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Roma RM, 00165, Italy
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Torino TO, 10126, Italy
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Napoli , 80131, Italy
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Obu Aichi, 474 8, Japan
Novartis Investigative Site
Sapporo city Hokkaido, 060 8, Japan
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Omura Nagasaki, 856-8, Japan
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Bunkyo ku Tokyo, 113 8, Japan
Novartis Investigative Site
Setagaya-ku Tokyo, 157-8, Japan
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Shinjuku ku Tokyo, 162 8, Japan
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Toyama-city Toyama, 930-0, Japan
Novartis Investigative Site
Saitama , 330 8, Japan
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Yangsan Si Gyeongsangnam Do, 50612, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Ashrafieh , 16683, Lebanon
Novartis Investigative Site
Beirut , 10999, Lebanon
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Warszawa , 04 73, Poland
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Wroclaw , 51-12, Poland
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Carnaxide Lisboa, 2799 , Portugal
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Coimbra , 3000 , Portugal
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Lisboa , 1169 , Portugal
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Moscow , 12541, Russian Federation
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Saint Petersburg , 19734, Russian Federation
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Singapore , 11926, Singapore
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Singapore , 22989, Singapore
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Soweto Gauteng, 2013, South Africa
Novartis Investigative Site
Cordoba Andalucia, 14004, Spain
Novartis Investigative Site
Barcelona Cataluna, 08950, Spain
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
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Madrid , 28009, Spain
Novartis Investigative Site
Madrid , 28046, Spain
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Lausanne , 1011, Switzerland
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Tainan , 70403, Taiwan
Novartis Investigative Site
Taipei , 10041, Taiwan
Novartis Investigative Site
Bangkoknoi Bangkok, 10700, Thailand
Novartis Investigative Site
Bangkok , 10400, Thailand
Novartis Investigative Site
Ankara , 06490, Turkey
Novartis Investigative Site
Izmir , 35040, Turkey
Novartis Investigative Site
Konak-Izmir , 35210, Turkey

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

216

Study ID:

NCT03785405

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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