At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 8 enrolled
Drug / intervention
sacubitril/valsartandrug
Likely dose
Not stated in 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, Open-label Study to Collect the Safety Information of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study
In Brief
A Phase 3 clinical trial evaluating sacubitril/valsartan for Heart Failure. Completed, enrolled 8 participants across 6 sites.
Detailed Summary
The purpose of this open-label study was to collect additional safety information of sacubitril/valsartan and to provide post-trial access to sacubitril/valsartan for the eligible Japanese patients who completed CLCZ696B2319E1(NCT03785405) study until marketed product of pediatric formulation, film-coated granules in capsule, is available in Japan.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
202420252026
First PostedNov 2023
Enrollment StartDec 2023
Primary CompletionAug 2024
TodayJul 2026
First PostedNov 28, 2023
Enrollment StartDec 4, 2023
Primary CompletionAug 14, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.6 years ago
Interventions
sacubitril/valsartandrug
sacubiril/valsartan