CLCZ696B2319E1 Open Label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With Heart Failure (HF).
- Conditions
- Heart failure patientsHF
- Registration Number
- LBCTR2019070266
- Lead Sponsor
- ovartis Pharma Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 9
Signed informed consent
On study drug at PANORAMA-HF Part 2 End of Study visit. Does not have any significant safety issue
Subject only participated in PANORAMA-HF Part 1 or was a Screen Failure 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: Number of participants with Adverse Events (AEs) as a measure of safety and tolerability;Timepoints: to end of study, up to 3 years ;Measure: safety and tolerability;Name: .Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability ;Timepoints: to end of study, up to 3 years ;Measure: safety and tolerability
- Secondary Outcome Measures
Name Time Method ame: No secondary objectives ;Timepoints: NA;Measure: NA