Heart Failure Clinical Trial
BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
Summary
A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.
Eligibility Criteria
Inclusion Criteria:
Male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
Subjects must have the clinical diagnosis of CHF made at least three months prior to enrollment
Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:
dyspnea and
clinical evidence of volume overload
Exclusion Criteria:
Acute de-novo heart failure
Acute myocardial infarction and/or myocardial infarction within 30 days
Valvular heart disease requiring surgical intervention during the course of the study
Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
Primary hypertrophic cardiomyopathy
Acute inflammatory heart disease, eg, acute myocarditis
Unstable angina requiring angiography
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There are 58 Locations for this study
Ridgewood New Jersey, 07450, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Fairfield Ohio, 45014, United States
Philadelphia Pennsylvania, 19102, United States
Philadelphia Pennsylvania, 19107, United States
Linz Oberösterreich, 4010, Austria
Wien , 1090, Austria
Zagreb , 10000, Croatia
Helsinki , 00029, Finland
Oulu , 90220, Finland
Greifswald Mecklenburg-Vorpommern, 17475, Germany
Köln Nordrhein-Westfalen, 50924, Germany
Homburg Saarland, 66424, Germany
Erfurt Thüringen, 99089, Germany
Jena Thüringen, 07740, Germany
Haifa , 34362, Israel
Jerusalem , 91120, Israel
Tiberias , 31905, Israel
San Fermo della Battaglia Como, 22020, Italy
Brescia , 25100, Italy
Ferrara , 44100, Italy
Mantova , 46100, Italy
Torino , 10126, Italy
Nagoya Aichi, 460-0, Japan
Kure Hiroshima, 737-0, Japan
Higashiibaraki Ibaraki, 311-3, Japan
Kawasaki Kanagawa, 216-8, Japan
Omura Nagasaki, 856-8, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Shinagawa Tokyo, 142-8, Japan
Osaka , 543-0, Japan
Gdansk , 80-21, Poland
Lodz , 91-34, Poland
Warszawa , 02-50, Poland
Warszawa , 04-62, Poland
Wroclaw , 50-98, Poland
Zabrze , 41-80, Poland
Zgorzelec , 59-90, Poland
Bucharest , 02232, Romania
Cluj-Napoca , 40000, Romania
Krasnoyarsk , 66002, Russian Federation
Moscow , 10926, Russian Federation
Moscow , 11509, Russian Federation
Moscow , 11988, Russian Federation
Beograd , 11000, Serbia
Nis , 18000, Serbia
Sremska Kamenica , 21204, Serbia
Lucenec , 984 3, Slovakia
Martin , 036 5, Slovakia
Celje , 3000, Slovenia
Golnik , 4204, Slovenia
Ljubljana , 1000, Slovenia
Göteborg , 413 4, Sweden
Uppsala , 751 8, Sweden
Lugano Ticino, 6900, Switzerland
Zürich , 8091, Switzerland
Bangkok , 10400, Thailand
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