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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06149104

Collaborator

(none)

Enrollment

Arm

8.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this open-label study is 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 study until marketed product of pediatric formulation, film-coated granules in capsule, is available in Japan.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: sacubitril/valsartan	Phase 3

Detailed Description

This trial (CLCZ696B2319E2) is a multicenter, open-label extension study for Japanese patients who have successfully completed the CLCZ696B2319E1 (PANORAMA-HF OLE) study. Only Japanese patients who successfully completed PANORAMA-HF OLE study and fulfill protocol requirements are eligible to participate in this study.

The first visit (Visit Day1) is the same day as the End of Study visit (Visit 599) of PANORAMA-HF OLE study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Anticipated Study Start Date :

Dec 15, 2023

Anticipated Primary Completion Date :

Aug 29, 2024

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sacubitril/valsartan single arm, open label sacubitril/valsartan	Drug: sacubitril/valsartan sacubiril/valsartan

Arm

Intervention/Treatment

Experimental: sacubitril/valsartan

single arm, open label sacubitril/valsartan

Drug: sacubitril/valsartan

sacubiril/valsartan

Outcome Measures

Primary Outcome Measures

Adverse events (AEs) [Up to 9 months]
Additional safety information of sacubitril/valsartan will be collected with Adverse events (AEs).

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent
Completed PANORAMA-HF OLE study and safely enrolled

Exclusion Criteria:

Permanently discontinued the study treatment during PANORAMA-HF OLE 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