Phase 3
Completed N=8
A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study
Source: ClinicalTrials.gov NCT06149104 ↗Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Feb 2025
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 6; 1 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
6; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- <18 years of age (at the time of signing informed consent)
- Completed CLCZ696B2319E1 study and safely enrolled
Exclusion Criteria
- Permanently discontinued the study treatment during CLCZ696B2319E1 study
- Renal vascular hypertension (including renal artery stenosis)
- History of angioedema
- Having parents or legal guardians who do not give consent or allow the child to give assent, or inability of patient or the 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
Data sourced from ClinicalTrials.gov (NCT06149104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.