Status:
COMPLETED
Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Failure
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate long-term safety and tolerability and to provide post-trial access to sacubitril/valsartan to eligible participants who successfully completed CLCZ696B2319 (P...
Detailed Description
This was a multicenter, open-label long-term extension study for participants who successfully completed PANORAMA-HF core study Part 2 of the trial or who discontinued study drug treatment early in Pa...
Eligibility Criteria
Inclusion
- Signed informed consent
- On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue
Exclusion
- 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
Key Trial Info
Start Date :
May 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2023
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT03785405
Start Date
May 2 2019
End Date
December 29 2023
Last Update
May 16 2025
Active Locations (79)
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1
Novartis Investigative Site
Loma Linda, California, United States, 92354
2
Novartis Investigative Site
Los Angeles, California, United States, 90095
3
Novartis Investigative Site
Palo Alto, California, United States, 94304
4
Novartis Investigative Site
St. Petersburg, Florida, United States, 33701