Trial Condition(s):

Congestive Heart Failure

Placebo controlled, randomized, double-blind, multi-center study to investigate the efficacy and tolerability of BAY58-2667

Bayer Identifier:

12480

ClinicalTrials.gov Identifier:

NCT00559650

EudraCT Number:

2007-003059-36

Terminated/Withdrawn

Trial Purpose

The purpose of this study is to assess a dose titration scheme, of a new drug (BAY58-2667) given intravenously, to evaluate if this is safe and can help to improve the well-being, symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with chronic heart failure have a risk of increased number of hospitalisations because of worsening of their condition (decompensated heart failure). The current treatment of acute heart failure consists of oxygen and medical treatment with vasodilators and positive inotropic agents (drugs, which should strengthen the pump function of the heart) which have their limitations. Therefore there is a need for new drugs in treatment of acute heat failure.

Inclusion Criteria
- Patients with decompensated chronic congestive heart failure, NYHA functional class III-IV, either ischemic or non-ischemic, requiring hospitalization, and with clinical indication for parenteral pharmacotherapy and invasive hemodynamic monitoring (i.e indwelling Swan-Ganz pulmonary artery catheter) and PCWP >/= 18 mmHg.
 - 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
- Females of child-bearing potential.
 - 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.

Trial Summary

Enrollment Goal
150
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Cinaciguat (BAY58-2667)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Halle, Germany, 06120

Status
Terminated
 
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Investigative Site

Erfurt, Germany, 99089

Status
Completed
 
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Investigative Site

Bad Oeynhausen, Germany, 32545

Status
Terminated
 
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Investigative Site

Harrow, United Kingdom, HA1 3UJ

Status
Terminated
 
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Investigative Site

Chesterfield, United Kingdom, S44 5BL

Status
Terminated
 
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Investigative Site

Washington, United States, 20010

Status
Terminated
 
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Investigative Site

Krakow, Poland, 31-202

Status
Terminated
 
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Investigative Site

Wroclaw, Poland, 50-981

Status
Completed
 
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Investigative Site

Pavia, Italy, 27100

Status
Completed
 
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Investigative Site

Perugia, Italy, 06156

Status
Terminated
 
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Investigative Site

Ferrara, Italy, 44100

Status
Completed
 
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Investigative Site

Bologna, Italy, 40138

Status
Completed
 
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Investigative Site

Bergamo, Italy, 24128

Status
Completed
 
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Investigative Site

Milano, Italy, 20162

Status
Terminated
 
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Investigative Site

Santiago de Compostela, Spain, 15706

Status
Terminated
 
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Investigative Site

Köln, Germany, 50924

Status
Completed
 
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Bad Nauheim, Germany, 61231

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Completed
 
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Homburg, Germany, 66424

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Completed
 
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Heidelberg, Germany, 69120

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Terminated
 
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Bonn, Germany, 53105

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Completed
 
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Würzburg, Germany, 97080

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Terminated
 
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Greifswald, Germany, 17475

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Completed
 
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Jena, Germany, 07740

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Completed
 
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Berlin, Germany, 12200

Status
Terminated
 
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Barnet, United Kingdom, EN5 3DJ

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Terminated
 
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Cincinnati, United States, 45219-2316

Status
Terminated
 
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Boston, United States, 02114

Status
Completed
 
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Fairfield, United States, 45014

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Completed
 
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San Diego, United States, 92103-8765

Status
Terminated
 
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Investigative Site

Girona, Spain, 17007

Status
Terminated
 
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Sabadell, Spain, 08208

Status
Terminated
 
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Investigative Site

Plzen, Czech Republic, 301 00

Status
Terminated
 
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Investigative Site

Brno, Czech Republic, 656 91

Status
Terminated
 
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Investigative Site

Hradec kralove, Czech Republic, 500 05

Status
Terminated
 
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Investigative Site

Praha 2, Czech Republic, 128 08

Status
Terminated
 
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Investigative Site

Praha 2, Czech Republic, 12808

Status
Terminated
 
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Investigative Site

Haifa, Israel, 34362

Status
Completed
 
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Investigative Site

Jerusalem, Israel, 9112001

Status
Terminated
 
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Investigative Site

Zalaegerszeg, Hungary, 8900

Status
Terminated
 
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Moscow, Russia, 119435

Status
Completed
 
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Investigative Site

Moscow, Russia, 115093

Status
Completed
 
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Kaunas, Lithuania, 50009

Status
Completed
 
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Vilnius, Lithuania, 08661

Status
Completed
 
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Tallin, Estonia, 13419

Status
Terminated
 
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Investigative Site

Murska Sobota, Slovenia, 9000

Status
Terminated
 
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Investigative Site

Dallas, United States, 75216-7167

Status
Terminated
 
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Investigative Site

Zabrze, Poland, 41-800

Status
Completed
 
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Investigative Site

Szczecin, Poland, 70-111

Status
Completed
 
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Investigative Site

Gdansk, Poland, 80-211

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08036

Status
Terminated
 
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Investigative Site

Majadahonda, Spain, 28222

Status
Completed
 
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Investigative Site

Halifax, Canada, B3H 3A7

Status
Terminated
 
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Investigative Site

Ste-Foy, Canada, G1V 4G5

Status
Completed
 
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Investigative Site

Toronto, Canada, M5B 1W8

Status
Terminated
 
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Investigative Site

Uppsala, Sweden, 751 85

Status
Terminated
 
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Investigative Site

Göteborg, Sweden, 413 45

Status
Terminated
 
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Investigative Site

Brno, Czech Republic, 625 00

Status
Terminated
 
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Investigative Site

Zefat, Israel, 1311001

Status
Completed
 
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Investigative Site

Ramat Gan, Israel, 5262000

Status
Terminated
 
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Investigative Site

Budapest, Hungary, H-1096

Status
Completed
 
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Investigative Site

Debrecen, Hungary, 4032

Status
Terminated
 
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Investigative Site

Vac, Hungary, 2600

Status
Terminated
 
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Investigative Site

Moscow, Russia, 109263

Status
Terminated
 
Locations

Investigative Site

Moscow, Russia, 129010

Status
Terminated
 
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Investigative Site

Tartu, Estonia, 51014

Status
Terminated
 
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Investigative Site

Ljubljana, Slovenia, 1000

Status
Completed
 
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Investigative Site

Golnik, Slovenia, 4204

Status
Terminated
 
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Investigative Site

Zagreb, Croatia, 10000

Status
Terminated
 
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Investigative Site

Split, Croatia, 21000

Status
Terminated
 
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Investigative Site

Beograd, Serbia, 11000

Status
Completed
 
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Investigative Site

Sremska Kamenica, Serbia, 21204

Status
Completed
 
Locations

Investigative Site

Celje, Slovenia, 3000

Status
Terminated
 
Locations

Investigative Site

Zagreb, Croatia, 10000

Status
Completed
 

Trial Design