Phase 3
N=216
Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03785405 ↗Enrolled (actual)
216
Serious AEs
39.1%
Results posted
Jul 2024
Primary outcome: Primary: Number of Participants With Adverse Events — 111; 78 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sacubitril/valsartan (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
111; 78 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
59; 25 | — |
| PRIMARY Duration of Drug Exposure |
894; 951 | — |
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 (PANORAMA-HF) core study Part 2 as per protocol.
Eligibility Criteria
Inclusion 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 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
Data sourced from ClinicalTrials.gov (NCT03785405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.