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

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Drug: sacubitril/valsartan

• Registration Number: NCT06149104
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-28
• Study Start: 2023-12-04
• Primary Completion: 2024-08-14
• Study Completion: 2024-08-14
• Status Verified: 2025-01
• Results First Submitted: 2025-01-27
• Results First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Results First Posted: 2025-02-18
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sacubitril/valsartan	sacubitril/valsartan	The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Toyama, Japan