The purpose of this study was to evaluate long-term safety and tolerability and to provide post-trial access to sacubitril/valsartan to eligible participants who successfully completed CLCZ696B2319 (PANORAMA-HF) core study Part 2 as per protocol.
This was a multicenter, open-label long-term extension study for participants who successfully completed PANORAMA-HF core study Part 2 of the trial or who discontinued study drug treatment early in Part 2 due to the implementation of Urgent safety measure (USM) of PANORAMA-HF core study. Provided that they fulfilled the protocol requirements, these patients were eligible to participate in the OLE. Depending on when and where the participant was enrolled, the duration of the study was of a minimum of 1 year, or until receipt of local marketing authorization and commercial availability, or reaching the maximum limit allowed by local regulations, or until Dec-2023, whichever occurred first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
216
Target dose 3.1 mg/kg bid Formulations: Tablets (50, 100, 200 mg) Granules \[12.5 mg (4 granules), 31.25 mg (10 granules), in capsules\] Liquid (1 mg/ml, 4 mg/ml, prepared from tablets)
Number of Participants With Adverse Events
Number of participants with at least one Adverse Events (AEs)
Time frame: to end of study, up to 4,5 years
Number of Participants With Serious Adverse Events
Number of participants with at least one Serious Adverse Events (SAEs)
Time frame: to end of study, up to 4.5 years
Duration of Drug Exposure
Median duration of exposure to sacubitril/valsartan (including temporary interruptions)
Time frame: Up to 4.5 years
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Novartis Investigative Site
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Rochester, Minnesota, United States
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