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


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.

Full Title of Study: “A Multicenter Study to Evaluate Long-term Safety and Tolerability of Open Label Sacubitril/Valsartan in Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed Study CLCZ696B2319”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 29, 2023


  • Drug: sacubitril/valsartan
    • Target dose 3.1 mg/kg bid Formulations: Tablets (50, 100, 200 mg) Granules [12.5 mg (4 granules), 31.25 mg (10 granules), in capsules] Liquid (1 mg/ml, 4 mg/ml, prepared from tablets)

Arms, Groups and Cohorts

  • Experimental: sacubitril/valsartan
    • single arm, open label sacubitril/valsartan

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
    • Time Frame: to end of study, up to 3 years
    • Safety. Assessments include: Adverse Events (AEs)
  • Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability
    • Time Frame: to end of study, up to 3 years
    • Safety. Assessments include: Serious Adverse Events (SAEs)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.