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A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously t...

Mise à jour : Il y a 5 ans
Référence : EUCTR2009-014377-40

A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects with Acute Decompensated Chronic Congestive Heart Failure (ADHF)

Femme et Homme

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Extrait

The primary objective of this study is to investigate the safety and efficacy of a fixed dose (150 µg/h, 100 µg/h, or 50 µg/h) over at least 24 hours and up to 48 hours of intravenous BAY 58-2667 in subjects with acute decompensated chronic congestive heart failure needing parenteral pharmacotherapy and invasive hemodynamic monitoring (ie, indwelling pulmonary artery catheter [Swan-Ganz]) and pulmonary capillary wedge pressure (PCWP) ≥ 20 mmHg with CI ≤ 2.5. The primary endpoint will be to evaluate the PCWP reduction at eight hours.

Critère d'inclusion

  • Acute Decompensated Chronic Congestive Heart Failure (ADHF)

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