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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


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

EXCLUSION CRITERIA

Exclusion Criteria:


  1. 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
  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)
  3. 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
  4. Renal vascular hypertension (including renal artery stenosis)
  5. 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
  6. History of angioedema
  7. 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
  8. 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
  9. * Other protocol defined inclusion/exclusion criteria may apply


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study Details


Contition
Heart Failure
Age (in years)
1 - 18
Phase
PHASE3
Participants Needed
216
Est. Completion Date
Dec 29, 2023
Treatment Type
INTERVENTIONAL

Sponsor
Novartis
ClinicalTrials.gov NCT Identifier
NCT03785405
Study Number
CLCZ696B2319E1

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