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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	sacubitril/valsartan	sacubiril/valsartan

Timeline

• Start date: 2023-12-04
• Primary completion: 2024-08-14
• Completion: 2024-08-14
• First posted: 2023-11-28
• Last updated: 2025-10-14
• Results posted: 2025-02-18

Locations

6 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study