Open Actively Recruiting

CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
1 Year
Maximum Age
18 Years

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

Join this Trial

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Study Stats
Protocol No.
19-000617
Category
Pediatrics
Contact
Vanessa De Paz
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03785405
For detailed technical eligibility, visit ClinicalTrials.gov.