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

Completed · Phase 3

Conditions studied: Heart Failure

In brief

The purpose of this study was to evaluate long-term safety and tolerability and to provide post-trial access to sacubitril/valsartan to eligible participants who successfully completed CLCZ696B2319 (PANORAMA-HF) core study Part 2 as per protocol.

Key facts

Study ID

NCT03785405

Run by

Novartis Pharmaceuticals

People needed

216

Starts

2019-05-02

Expected to finish

2023-12-29

Last updated by the study team

2025-05-16

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Palo Alto, California, United States
• Novartis Investigative Site — St. Petersburg, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Salta, Salta Province, Argentina
• Novartis Investigative Site — Innsbruck, Austria
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Zagreb, Croatia
• Novartis Investigative Site — Prague, Czechia
• Novartis Investigative Site — Helsinki, Finland
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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