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Placebo controlled, randomized, double-blind, multi-center, multinational Phase IIb study to investigate the efficacy and tolerability of BAY 58-2667 given intravenously in patients with decompensated...

Update Il y a 4 ans
Reference: EUCTR2007-003059-36

Placebo controlled, randomized, double-blind, multi-center, multinational Phase IIb study to investigate the efficacy and tolerability of BAY 58-2667 given intravenously in patients with decompensated chronic congestive heart failure

Woman and Man

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Extract

Primary objective of the study is to investigate the safety and efficacy of a titration phase (8 hours) and a maintenance phase (maximum 40 hours) of intravenous BAY 58-2667 in patients with acute decompensated chronic congestive heart failure with the need for parenteral pharmacotherapy and invasive haemodynamic monitoring (i.e. indwelling Swan-Ganz pulmonary artery catheter) and PCWP ≥ 18mmHg.

Inclusion criteria

  • Patients with acute decompensated chronic congested heart failure

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