CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failure
- Conditions
- Pediatric 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]
- Registration Number
- EUCTR2018-004154-25-PT
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 215
- 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: 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to evaluate long-term safety and tolerability<br>and to provide post trial access to sacubitril/valsartan to eligible<br>CLCZ696B2319 (PANORAMA-HF) patients.;Secondary Objective: Not applicable;Primary end point(s): Number of participants with Adverse Events (AEs), Serious Adverse Events, as a measure of safety and tolerability;Timepoint(s) of evaluation of this end point: to end of study, up to 3 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable