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

• Status: Active, not recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Sacubitril and valsartan sodium hydrate drug combination; Valsartan

Criteria

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