Clinical Trials List
2019-05-03 - 2023-12-28
Phase III
Not yet recruiting1
Recruiting2
ICD-10I50.9
Heart failure, unspecified
ICD-9428.9
Heart failure, unspecified
A Multicenter Study to Evaluate Long-term Safety and Tolerability of Open Label Sacubitril/Valsartan in Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed Study CLCZ696B2319
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 謝旻玲 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jou Kou Wang Division of Pediatrics
- 陳俊安 Division of Pediatrics
- 黃書健 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Number of participants with Adverse Events (AEs) as a measure of safety and tolerability [ Time Frame: to end of study, up to 3 years ]
Safety. Assessments include: Adverse Events (AEs)
Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability [ Time Frame: to end of study, up to 3 years ]
Safety. Assessments include: Serious Adverse Events (SAEs)
Inclution Criteria
Signed informed consent
On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue
Exclusion Criteria
Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or permanently discontinued study drug in PANORMA-HF Part 2
Use of investigational drugs within 5 half-lives of enrollment or within 30 days (longer duration); with the exception of PANORAMA-HF study drug (requires >/=36-hour washout before baseline visit)
History of hypersensitivity or allergy to study treatment, its excipients or drugs of similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected contraindications to sacubitril/valsartan
Renal vascular hypertension (including renal artery stenosis)
Significant renal estimated glomerular filtration rate disorder (eGFR calculated using modified Schwartz formula <30% mean GFR for age); hepatic disorder (serum aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal); gastrointestinal disorder or biliary disorder
History of angioedema
Parents or legal guardians of subject who do not give consent or allow the child to give assent, or inability of patient or 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
Other protocol defined inclusion/exclusion criteria may apply
The Estimated Number of Participants
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Taiwan
6 participants
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Global
218 participants
