drugset / Trial / 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

NCT06149104 ↗

Phase 3 Completed 8 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-12-04
Primary completion
2024-08-14
Completion
2024-08-14

Drugs

EvaluationDrugModalityDoseRoute
Subject sacubitril/valsartan Unknown — —

Indications