At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 216 enrolled
Drug / intervention
sacubitril/valsartandrug
Likely dose
sacubitril/valsartan 3.1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating sacubitril/valsartan for Heart Failure. Completed, enrolled 216 participants across 79 sites in 27 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesArgentina, Austria, Bulgaria, Canada, Croatia, Czechia, Finland, France, Germany, Hungary, India, Israel, Italy, Japan, Lebanon, Poland, Portugal, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartMay 2019
Primary CompletionDec 2023
TodayJul 2026
First PostedDec 24, 2018
Enrollment StartMay 2, 2019
Primary CompletionDec 29, 2023
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 7.5 years ago
Interventions
sacubitril/valsartandrug
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)