Phase 3 N=8 Treatment

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

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT06149104 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Feb 2025

Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 6; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: sacubitril/valsartan (Drug)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	6; 1	—

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.

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

View full record on ClinicalTrials.gov →

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.