Heart Failure Clinical Trial
A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to 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 Congestive Heart Failure (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 28 Locations for this study
Birmingham Alabama, 35294, United States
Jacksonville Florida, 32209, United States
Boston Massachusetts, 02114, United States
Cincinnati Ohio, 45267, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19141, United States
Quilmes Buenos Aires, , Argentina
Buenos Aires Ciudad Auton. de Buenos Aires, 1078, Argentina
Buenos Aires Ciudad Auton. de Buenos Aires, C1039, Argentina
Buenos Aires Ciudad Auton. de Buenos Aires, C1181, Argentina
Buenos Aires Ciudad Auton. de Buenos Aires, C1428, Argentina
Graz Steiermark, 8020, Austria
Innsbruck Tirol, 6020, Austria
Aalst , 9300, Belgium
Bruxelles - Brussel , 1070, Belgium
Leuven , 3000, Belgium
Creteil , 94010, France
PARIS cedex 10 , 75475, France
Toulouse , 31403, France
Bad Krozingen Baden-Württemberg, 79189, Germany
Bad Nauheim Hessen, 61231, Germany
Bad Oeynhausen Nordrhein-Westfalen, 32545, Germany
Düsseldorf Nordrhein-Westfalen, 40225, Germany
Berlin , 12559, Germany
Dublin , DUBLI, Ireland
Guadalajara Jalisco, 44280, Mexico
Guadalajara Jalisco, 44670, Mexico
Mexico D.F. México, 57000, Mexico
México D.F. , , Mexico
Quezon City , 1102, Philippines
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