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)
NCT ID: NCT01064037
Last Updated: 2015-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
62 participants
INTERVENTIONAL
2010-04-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Cinaciguat (BAY58-2667)
Infusion of 150 µg/h during 48h.
Arm 2
Cinaciguat (BAY58-2667)
Infusion of 100 µg/h during 48h
Arm 3
Cinaciguat (BAY58-2667)
Infusion of 50 µg/h during 48h
Arm 4
Placebo
Infusion during 48h
Interventions
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Cinaciguat (BAY58-2667)
Infusion of 150 µg/h during 48h.
Cinaciguat (BAY58-2667)
Infusion of 100 µg/h during 48h
Cinaciguat (BAY58-2667)
Infusion of 50 µg/h during 48h
Placebo
Infusion during 48h
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Chicago, Illinois, United States
Detroit, Michigan, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Québec, Quebec, Canada
Brno, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Jyväskylä, Jyväskylä, Finland
Turku, Turku, Finland
Dommartin-lès-Toul, , France
Paris, , France
Paris, , France
Paris, , France
Poitiers, , France
Nuremberg, Bavaria, Germany
Melsungen, Hesse, Germany
Mönchengladbach, North Rhine-Westphalia, Germany
Kiel, Schleswig-Holstein, Germany
Berlin, State of Berlin, Germany
Erfurt, Thuringia, Germany
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Kecskemét, , Hungary
Székesfehérvár, , Hungary
Ballinasloe, Co. Galway, Ireland
Dublin, Dublin, Ireland
Dublin, , Ireland
Haifa, Israel, Israel
Rehovot, Israel, Israel
Safed, Israel, Israel
Nahariya, , Israel
Pontedecimo, Genova, Italy
Casarano, Lecce, Italy
Cotignola, Ravenna, Italy
Bari, , Italy
Ferrara, , Italy
Padua, , Italy
Roma, , Italy
Roma, , Italy
Kanazawa, Ishikawa-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Chigasaki, Kanagawa, Japan
Matsumoto, Nagano, Japan
Shizuoka, Shizuoka, Japan
Sunto, Shizuoka, Japan
Tanabe, Wakayama, Japan
Bydgoszcz, , Poland
Krakow, , Poland
Olsztyn, , Poland
Szczecin, , Poland
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Kuils River, Western Cape, South Africa
Worcester, Western Cape, South Africa
Seoul, Jongno-gu,, South Korea
Seoul, Songpa-gu, South Korea
Torrevieja, Alicante, Spain
Barcelona, Barcelona, Spain
Majadahonda, Madrid, Spain
El Palmar, Murcia, Spain
Harrow, London, United Kingdom
Northampton, Northamptonshire, United Kingdom
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2009-017082-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14836
Identifier Type: -
Identifier Source: org_study_id
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