Pediatric heart failure : Patients (= 13 months) with HF due to systemic left ventricular systolic dysfunction. [Note: All patients per protocol for the core study CLCZ696B2319 (PANORAMA-HF) are to be <18 yrs at screening (enrollment). Patients will be 1 yr older when they are potentially eligible for entry in the OLE Study CLCZ696B2319E1]. Subjects who turned 18 yrs old during the PANORAMA-HF study, and who qualify, are eligible to participate in the OLE study. Ref section F.1.2 MedD
Conditions
Interventions
Product Name: LCZ696 12.5 mg film-coated granules in capsule (4 x 3.125 mg film-coated granules)
Product Code: LCZ696
Pharmaceutical Form: Granules
INN or Proposed INN: sacubitril/valsartan
Other desc
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed informed consent - On study drug at PANORAMA-HF Part 2 End of Study visit. Does not have any significant safety issue Are the trial subjects under 18? yes Number of subjects for this age range: 240 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to further evaluate long-term safety and tolerability data of sacubitril/valsartan in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.;Secondary Objective: Not applicable;Primary end point(s): Number of participants with Adverse Events (AEs), Serious Adverse Events, as a measure of safety and tolerability;Timepoint(s) of evaluation of this end point: to end of study, up to 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Argentina, Austria, Belgium, Bulgaria, Canada, China, Croatia, Czech Republic, Egypt, Finland, France, Germany, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Republic of, Lebanon, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactInformation&Communication Médicale
Novartis Pharma S.A.S
Outcome results
None listed