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Completed

NCT Number: NCT06149104

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Ōbu, Aichi-ken, Japan

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About this study

This trial (CLCZ696B2319E2) was a multicenter, open-label extension study for Japanese patients who have successfully completed the CLCZ696B2319E1 study. Only Japanese patients who successfully completed CLCZ696B2319E1 study and fulfilled protocol requirements were eligible to participate in this study.

The first visit (Visit Day1) was the same day as the End of Study visit of CLCZ696B2319E1 study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sacubitril/valsartan

Drug

sacubiril/valsartan

Primary outcomes

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

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

    Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2023
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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