Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Pati… (NCT03785405) | Clinical Trial Compass
CompletedPhase 3
Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF
United States216 participantsStarted 2019-05-02
Plain-language summary
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.
Who can participate
Age range1 Year – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 m…
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: to end of study, up to 4,5 years
2
Number of Participants With Serious Adverse Events