CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failure

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224897

Enrollment

240

Registered

2019-09-30

Start date

2019-10-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Heart Failure

Interventions

Investigational Material(s) Generic Name: sacubitril/valsartan Dosage and Administration: Target dose is 3.1 mg/kg bid Formulations: Select from Tablets, Granules and Liquid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue

Exclusion criteria

Exclusion criteria: - On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue - Renal vascular hypertension (including renal artery stenosis) - Significant renal estimated glomerular filtration rate disorder, hepatic disorder, gastrointestinal disorder or biliary disorder - History of angioedema

Design outcomes

Primary

Measure	Time frame
safety AEs, SAEs	—

Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Contacts

Public ContactHideki Maruyama

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026