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

Novartis Pharmaceuticals8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

sacubitril/valsartanDRUG

sacubiril/valsartan

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent * \<18 years of age (at the time of signing informed consent) * Completed CLCZ696B2319E1 study and safely enrolled Exclusion Criteria: * Permanently discontinued the study treatment during CLCZ696B2319E1 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

Locations (6)

Novartis Investigative Site

Ōbu, Aichi-ken, Japan

Novartis Investigative Site

Ōmura, Nagasaki, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Setagaya-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.

Time frame: Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.

Data from ClinicalTrials.gov

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