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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 (50 μg/h, 100 μg/h, 150 μg/h) Given Intravenously t...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-017082-39

A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 μg/h, 100 μg/h, 150 μg/h) Given Intravenously to Subjects with Acute Decompensated Chronic Congestive Heart Failure (ADHF) within 12 hours after hospital admission (Pulmonary Artery Catheter eg, Swan-Ganz not required

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Extrait

To investigate the safety and efficacy of a fixed dose of intravenous BAY 58-2667 (50 μg/h, 100 μg/h, or 150 μg/h) over at least 24 hours and up to 48 hours in subjects with ADHF needing parenteral pharmacotherapy. The focus of the study will be to evaluate the subjects well-being based on the subjects symptoms and reported outcomes ie, Dyspnea VAS, Likert score, and EQ-5D at baseline, 8 hours, 24 hours, 48 hours, at discharge (or at Day 7), and at the follow-up visit, and the global clinical assessment by the physician at 8 hours, 24 hours and 48 hours. The primary efficacy endpoint will be the change from baseline to 8 hours (or Last Observation Carried Forward [LOCF]) on the Dyspnea VAS

Critère d'inclusion

  • Acute Decompensated Chronic Congestive Heart Failure (ADHF)

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