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

Update Il y a 4 ans
Reference: EUCTR2016-004062-26

Woman and Man

  • | Country :
  • -
  • | organs :
  • -
  • | Specialty :
  • -

Extract

Find the optimal dose of neladenoson bialanate for the Phase III trial by detecting and characterizing a significant dose-response relationship in the primary efficacy endpoint, absolute change from baseline in 6-minute walking distance (6MWD) at 20 weeks, in patients with chronic heart failure with preserved ejection fraction (HFpEF), and by characterizing the safety, tolerability, pharmacokinetic and pharmacodynamic effects of the compound when given in addition to appropriate therapy for specific co-morbidities


Inclusion criteria

  • chronic heart failure with preserved ejection fraction (LVEF equal or above 45%)