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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT01067859

Recruitment Status:

Terminated

Sponsor:

Bayer

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There are 28 Locations for this study

See Locations Near You


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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT01067859

Recruitment Status:

Terminated

Sponsor:


Bayer

How clear is this clinincal trial information?

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