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Clinical Trials/EUCTR2018-004154-25-ES
EUCTR2018-004154-25-ES
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 (PANORAMA-HF)

ovartis Farmacéutica, S.A.0 sites240 target enrollmentDecember 2, 2019
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ovartis Farmacéutica, S.A.
Enrollment
240
Status
Active, Not Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 2, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
ovartis Farmacéutica, S.A.

Eligibility Criteria

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

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 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 failure
EUCTR2018-004154-25-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
Completed
Phase 3
CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failure
JPRN-jRCT2080224897ovartis Pharma. K.K.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 failure
EUCTR2018-004154-25-FIovartis Pharma AG240