CompletedPhase 3

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

Japan8 participantsStarted 2023-12-04

Plain-language 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.

Who can participate

Age range3 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.

Trial details

NCT IDNCT06149104

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-14

Results submitted2025-01-27