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NCT06149104 Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data
NCT number NCT06149104
Other study ID # CLCZ696B2319E2
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 4, 2023
Est. completion date August 30, 2024

Study information
Verified date March 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 8
Est. completion date August 30, 2024
Est. primary completion date August 29, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• sacubitril/valsartan
sacubiril/valsartan

Locations
Country Name City State
Japan Novartis Investigative Site Bunkyo ku Tokyo
Japan Novartis Investigative Site Obu Aichi
Japan Novartis Investigative Site Omura Nagasaki
Japan Novartis Investigative Site Saitama
Japan Novartis Investigative Site Setagaya-ku Tokyo
Japan Novartis Investigative Site Toyama-city Toyama

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events (AEs) Additional safety information of sacubitril/valsartan will be collected with Adverse events (AEs). Up to 9 months
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