BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
NCT ID: NCT01065077
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2010-03-31
2011-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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)
NCT01067859
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)
NCT01064037
Placebo Controlled, Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Tolerability of BAY58-2667
NCT00559650
Study to Assess the Safety of BAY1067197 in Stable Heart Failure Patients on Standard Therapy Including ß-blocker
NCT01945606
Multiple Dose Study in Heart Failure of BAY 1067197
NCT02040233
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 of placebo during 48h
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 of placebo during 48h
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects must have the clinical diagnosis of 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
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ridgewood, New Jersey, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Fairfield, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Linz, Upper Austria, Austria
Vienna, Vienna, Austria
Zagreb, , Croatia
Helsinki, , Finland
Oulu, , Finland
Greifswald, Mecklenburg-Vorpommern, Germany
Cologne, North Rhine-Westphalia, Germany
Homburg, Saarland, Germany
Erfurt, Thuringia, Germany
Jena, Thuringia, Germany
Haifa, Israel, Israel
Jerusalem, Israel, Israel
Tiberias, Israel, Israel
San Fermo della Battaglia, Como, Italy
Brescia, , Italy
Ferrara, , Italy
Mantova, , Italy
Torino, , Italy
Nagoya, Aichi-ken, Japan
Kure, Hiroshima, Japan
Higashiibaraki, Ibaraki, Japan
Kawasaki, Kanagawa, Japan
Ōmura, Nagasaki, Japan
Osaka, Osaka, Japan
Bunkyo-ku, Tokyo, Japan
Shinagawa, Tokyo, Japan
Gdansk, , Poland
Lodz, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Zabrze, , Poland
Zgorzelec, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Krasnoyarsk, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Belgrade, , Serbia
Kamenitz, , Serbia
Niš, , Serbia
Lučenec, , Slovakia
Martin, , Slovakia
Celje, , Slovenia
Golnik, , Slovenia
Ljubljana, , Slovenia
Gothenburg, , Sweden
Uppsala, , Sweden
Zurich, Canton of Zurich, Switzerland
Lugano, Canton Ticino, Switzerland
Bangkok, Thailand, Thailand
Bangkok, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gheorghiade M, Greene SJ, Filippatos G, Erdmann E, Ferrari R, Levy PD, Maggioni A, Nowack C, Mebazaa A; COMPOSE Investigators and Coordinators. Cinaciguat, a soluble guanylate cyclase activator: results from the randomized, controlled, phase IIb COMPOSE programme in acute heart failure syndromes. Eur J Heart Fail. 2012 Sep;14(9):1056-66. doi: 10.1093/eurjhf/hfs093. Epub 2012 Jun 19.
Related Links
Access external resources that provide additional context or updates about the study.
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-014377-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14560
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.