EUCTR2018-004154-25-FI
Active, not recruiting
Phase 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
DrugsEntresto
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma AG
- Enrollment
- 240
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Signed informed consent as well as assent at an appropriate age based on country regulations.
- •\- On study drug at PANORAMA\-HF Part 2 End of Study visit or discontinued from the study drug treatment early due to the implementation of the USM. Does not have any significant safety issue.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 214
- •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 for reasons other than the implementation of the USM.
- •\- 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 initiation of study treatment (Visit 501\).
- •\- 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
Outcomes
Primary Outcomes
Not specified
Similar Trials
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CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failureEUCTR2018-004154-25-ESovartis Farmacéutica, S.A.240
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CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failurePediatric heart failure : Patients (= 13 months) with HF due to systemic left ventricular systolic dysfunction. [Note: All patients per protocol for the core study CLCZ696B2319 (PANORAMA-HF) are to be <18 yrs at screening (enrollment). Patients will be 1 yr older when they are potentially eligible for entry in the OLE Study CLCZ696B2319E1]. Subjects who turned 18 yrs old during the PANORAMA-HF study, and who qualify, are eligible to participate in the OLE study. Ref section F.1.2MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2018-004154-25-FRovartis Pharma AG240
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CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failurePediatric heart failure : Patients (= 13 months) with HF due to systemic left ventricular systolic dysfunction. [Note: All patients per protocol for the core study CLCZ696B2319 (PANORAMA-HF) are to be <18 yrs at screening (enrollment). Patients will be 1 yr older when they are potentially eligible for entry in the OLE Study CLCZ696B2319E1]. Subjects who turned 18 yrs old during the PANORAMA-HF study, and who qualify, are eligible to participate in the OLE study. Ref section F.1.2MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2018-004154-25-HUovartis Pharma AG240
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CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failureJPRN-jRCT2080224897ovartis Pharma. K.K.240