For Healthcare Professionals

CLCZ696B2319E1 OL 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 is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.
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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’s details


Contition

Heart Failure

Age (in years)

1 - 18

Phase

Phase 3

Participants needed

216

Est. Completion Date

Dec 29, 2023

Treatment type

Interventional


Sponsor

Novartis

ClinicalTrials.gov identifier

NCT03785405

Study number

CLCZ696B2319E1

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