Heart Failure Clinical Trial

A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects 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 ovarectomy, 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:

62

Study ID:

NCT01064037

Recruitment Status:

Terminated

Sponsor:

Bayer

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There are 66 Locations for this study

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Chicago Illinois, 60610, United States

Detroit Michigan, 48201, United States

Cincinnati Ohio, 45267, United States

Cleveland Ohio, 44195, United States

Nashville Tennessee, 37232, United States

Houston Texas, 77030, United States

Calgary Alberta, T2N 4, Canada

Vancouver British Columbia, V5Z 1, Canada

Quebec , G1V 4, Canada

Brno , 625 0, Czech Republic

Pardubice , 532 0, Czech Republic

Praha 10 , 10034, Czech Republic

Praha 5 , 15006, Czech Republic

Praha 5 , 15030, Czech Republic

Jyväskylä , , Finland

Turku , , Finland

Dommartin-les-toul , 54201, France

Paris Cedex 04 , 75181, France

Paris cedex 13 , 75013, France

Paris , 75475, France

POITIERS Cedex , 86021, France

Nürnberg Bayern, 90471, Germany

Melsungen Hessen, 34212, Germany

Mönchengladbach Nordrhein-Westfalen, 41063, Germany

Kiel Schleswig-Holstein, 24105, Germany

Erfurt Thüringen, 99089, Germany

Berlin , 12200, Germany

Budapest , 1027, Hungary

Budapest , 1096, Hungary

Budapest , H-109, Hungary

Kecskemet , 6000, Hungary

Szekesfehervar , 8000, Hungary

Ballinasloe Co. Galway, , Ireland

Dublin , 8, Ireland

Dublin , DUBLI, Ireland

Haifa , 31096, Israel

Nahariya , , Israel

Rehovot , 76100, Israel

Safed , 13100, Israel

Pontedecimo Genova, 16164, Italy

Casarano Lecce, 73042, Italy

Cotignola Ravenna, 48010, Italy

Bari , 70124, Italy

Ferrara , 44100, Italy

Padova , 35128, Italy

Roma , 00161, Italy

Roma , 00192, Italy

Kanazawa Ishikawa, 920-8, Japan

Chigasaki Kanagawa, 253-8, Japan

Matsumoto Nagano, 399-8, Japan

Sunto Shizuoka, 411-8, Japan

Tanabe Wakayama, 646-8, Japan

Kagoshima , 892-0, Japan

Shizuoka , 421-0, Japan

Seoul Jongno-gu,, 110-7, Korea, Republic of

Seoul Songpa-gu, 138-7, Korea, Republic of

Bydgoszcz , 85-68, Poland

Krakow , 31-12, Poland

Olsztyn , 10-22, Poland

Szczecin , 70-96, Poland

Johannesburg Gauteng, 1449, South Africa

Johannesburg Gauteng, 2194, South Africa

Kuils River Western Cape, 7580, South Africa

Worcester Western Cape, 6850, South Africa

Torrevieja Alicante, 03186, Spain

Majadahonda Madrid, 28222, Spain

El Palmar Murcia, 30120, Spain

Barcelona , 08035, Spain

Harrow London, HA1 3, United Kingdom

Northampton Northamptonshire, NN1 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

62

Study ID:

NCT01064037

Recruitment Status:

Terminated

Sponsor:


Bayer

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