Placebo Controlled, Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Tolerability of BAY58-2667
NCT ID: NCT00559650
Last Updated: 2017-04-18
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
150 participants
INTERVENTIONAL
2007-12-31
2009-03-31
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
BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
NCT01065077
Study to Assess the Safety of BAY1067197 in Stable Heart Failure Patients on Standard Therapy Including ß-blocker
NCT01945606
Study to Evaluate the Effects of Oral Administration of Lixivaptan in Patients With Congestive Heart Failure
NCT01055912
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
Placebo
Will be standard therapy and placebo versus, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
Arm 2
Cinaciguat (BAY58-2667)
Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Will be standard therapy and placebo versus, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
Cinaciguat (BAY58-2667)
Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must have the clinical diagnosis of CHF made at least 3 month prior to enrollment.
* Male or female patients, age 18 years or more.
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.
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.
San Diego, California, United States
Washington D.C., District of Columbia, United States
Boston, Massachusetts, United States
Cincinnati, Ohio, United States
Fairfield, Ohio, United States
Dallas, Texas, United States
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Ste-Foy, Quebec, Canada
Split, , Croatia
Zagreb, , Croatia
Brno, , Czechia
Brno, , Czechia
Hradec Králové, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Prague, , Czechia
Tallinn, , Estonia
Tartu, , Estonia
Heidelberg, Baden-Wurttemberg, Germany
Würzburg, Bavaria, Germany
Bad Nauheim, Hesse, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Bad Oeynhausen, North Rhine-Westphalia, Germany
Bonn, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Homburg, Saarland, Germany
Halle, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Erfurt, Thuringia, Germany
Jena, Thuringia, Germany
Budapest, , Hungary
Debrecen, , Hungary
Vác, , Hungary
Zalaegerszeg, , Hungary
Haifa, Israel, Israel
Jerusalem, , Israel
Ramat Gan, , Israel
Safed, , Israel
Bologna, Emilia-Romagna, Italy
Ferrara, Emilia-Romagna, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Perugia, Umbria, Italy
Bergamo, , Italy
Kaunas, , Lithuania
Vilnius, , Lithuania
Gdansk, , Poland
Krakow, , Poland
Szczecin, , Poland
Wroclaw, , Poland
Zabrze, , Poland
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Belgrade, , Serbia
Kamenitz, , Serbia
Celje, , Slovenia
Golnik, , Slovenia
Ljubljana, , Slovenia
Murska Sobota, , Slovenia
Santiago de Compostela, A Coruña, Spain
Barcelona, Barcelona, Spain
Sabadell, Barcelona, Spain
Girona, Girona, Spain
Majadahonda, Madrid, Spain
Gothenburg, , Sweden
Uppsala, , Sweden
Chesterfield, Derbyshire, United Kingdom
Barnet, Hertfordshire, United Kingdom
Harrow, Middlesex, United Kingdom
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.
Erdmann E, Semigran MJ, Nieminen MS, Gheorghiade M, Agrawal R, Mitrovic V, Mebazaa A. Cinaciguat, a soluble guanylate cyclase activator, unloads the heart but also causes hypotension in acute decompensated heart failure. Eur Heart J. 2013 Jan;34(1):57-67. doi: 10.1093/eurheartj/ehs196. Epub 2012 Jul 9.
Related Links
Access external resources that provide additional context or updates about the study.
Click here and search for Bayer product information provided by EMA
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007-003059-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12480
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.