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)
NCT ID: NCT01067859
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
5 participants
INTERVENTIONAL
2010-03-31
2010-11-30
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 25 µg/h during 48 hours
Arm 2
Cinaciguat (BAY58-2667)
Infusion of 10 µg/h during 48 hours
Arm 3
Placebo
Infusion of placebo during 48 hours
Interventions
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Cinaciguat (BAY58-2667)
Infusion of 25 µg/h during 48 hours
Cinaciguat (BAY58-2667)
Infusion of 10 µg/h during 48 hours
Placebo
Infusion of placebo during 48 hours
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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Birmingham, Alabama, United States
Jacksonville, Florida, United States
Boston, Massachusetts, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Quilmes, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Graz, Styria, Austria
Innsbruck, Tyrol, Austria
Aalst, , Belgium
Bruxelles - Brussel, , Belgium
Leuven, , Belgium
Créteil, , France
Paris, , France
Toulouse, , France
Bad Krozingen, Baden-Wurttemberg, Germany
Bad Nauheim, Hesse, Germany
Bad Oeynhausen, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Berlin, State of Berlin, Germany
Dublin, , Ireland
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Mexico City, Mexico City, Mexico
México D.F., , Mexico
Quezon City, , Philippines
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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2009-014378-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14663
Identifier Type: -
Identifier Source: org_study_id
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