EUCTR2018-004154-25-HUActive, not recruitingPhase 1
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 (PANORAMA-HF)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma AG
- Enrollment
- 240
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Signed informed consent
- •- On study drug at PANORAMA-HF Part 2 End of Study visit. Does not have any significant safety issue
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 240
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- Subject only participated in PANORAMA-HF Part 1 or was a Screen Failure 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
Investigators
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