Overview

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

Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
LCZ 696
Valsartan
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