Heart Failure With Preserved Ejection Fraction (HFpEF) Clinical Trial
Official title:
A Multicenter, Open-label Study to Evaluate the Safety and Tolerability of LCZ696 Treatment in Japanese Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction After CLCZ696D2301 (PARAGON-HF)
This study evaluated the safety and tolerability of LCZ696 treatment in Japanese heart failure patients (NYHA Class II-IV) with preserved ejection fraction after CLCZ696D2301 (PARAGON-HF).
This study was an open-label extension study following the PARAGON-HF. Patients who have completed the PARAGON-HF were eligible to participate. During the study, open-label LCZ696 was taken in addition to background treatments of comorbidities. All subjects were treated with LCZ696 (sacubitril/valsartan) at maximally tolerated dosed with a target dose of 200 mg b.i.d (twice a day). The subject were to continue to receive LCZ696 until it became commercially available, or for a period up to 24 months from the first patient enrolled in this study whichever came first. However, this study was terminated early based on the pre-defined early termination criteria of "the primary endpoint of PARAGONHF was not met" in the protocol. ;
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