A phase II trial to study neladenoson bialanate over 20 weeks in patients with chronic heart failure with reduced ejection fraction

Update Il y a 4 ans
Reference: EUCTR2016-003839-38

Woman and Man

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Extract

Find the optimal dose of neladenoson bialanate for the Phase III trial by detecting and characterizing a significant dose-response relationship in the two primary efficacy endpoints, absolute change from baseline in LVEF and log-transformed NT-proBNP at 20 weeks, in patients with chronic heart failure with reduced ejection fraction (HFrEF), and by characterizing the safety, tolerability and pharmacodynamic effects of the compound when given in addition to standard therapy for HFrEF.


Inclusion criteria

  • chronic heart failure with reduced ejection fraction (LVEF equal or below 35%)