JPRN-jRCT2080224897
Completed
Phase 3
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
ovartis Pharma. K.K.0 sites240 target enrollmentSeptember 30, 2019
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma. K.K.
- Enrollment
- 240
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •On study drug at PANORAMA\-HF Part 2 EOS visit. Does not have any significant safety issue
Exclusion Criteria
- •\- On study drug at PANORAMA\-HF Part 2 EOS visit. Does not have any significant safety issue
- •\- Renal vascular hypertension (including renal artery stenosis)
- •\- Significant renal estimated glomerular filtration rate disorder, hepatic disorder, gastrointestinal disorder or biliary disorder
- •\- History of angioedema
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
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
Active, not recruiting
Phase 1
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
Active, not recruiting
Phase 1
CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failureEUCTR2018-004154-25-BGovartis Pharma AG240
Active, not recruiting
Phase 1
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
Active, not recruiting
Phase 1
CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failureEUCTR2018-004154-25-FIovartis Pharma AG240