Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Failure
Eligibility:
All Genders
3-18 years
Phase:
PHASE3
Brief 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 wh...
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 comple...
Eligibility Criteria
Inclusion
- Signed informed consent
- \<18 years of age (at the time of signing informed consent)
- Completed CLCZ696B2319E1 study and safely enrolled
Exclusion
- 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
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06149104
Start Date
December 4 2023
End Date
August 14 2024
Last Update
October 14 2025
Active Locations (6)
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1
Novartis Investigative Site
Ōbu, Aichi-ken, Japan, 474 8710
2
Novartis Investigative Site
Ōmura, Nagasaki, Japan, 856-8562
3
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan, 113 8655
4
Novartis Investigative Site
Setagaya-ku, Tokyo, Japan, 157-8535