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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 Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06149104
Study type Interventional
Source Novartis
Contact
Status Active, not recruiting
Phase Phase 3
Start date December 4, 2023
Completion date August 30, 2024
View Details
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