Trial Condition(s):

Acute Heart Failure

BAY58-2667 dose finding trial investigating fixed doses in patients with acute decompensated chronic congestive heart failure (ADHF) (COMPOSE 1)

Bayer Identifier:

14560

ClinicalTrials.gov Identifier:

NCT01065077

EudraCT Number:

2009-014377-40

Terminated/Withdrawn

Trial Purpose

A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.

Inclusion Criteria
- Male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
 - 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 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
 - 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

Trial Summary

Enrollment Goal
12
Trial Dates
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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

HELIOS Klinikum Erfurt GmbH

Erfurt, Germany, 99089

Status
Completed
 
Locations

Universitätskliniken des Saarlandes

Homburg, Germany, 66424

Status
Completed
 
Locations

CSK MSWiA

Warszawa, Poland, 02-507

Status
Terminated
 
Locations

St. Marianna University of School Medicine Hospital

Kawasaki, Japan, 216-8511

Status
Terminated
 
Locations

Kure Medical Center

Kure, Japan, 737-0023

Status
Terminated
 
Locations

Nagasaki Medical Center

Omura, Japan, 856-8562

Status
Terminated
 
Locations

A.O.U. di Ferrara

Ferrara, Italy, 44100

Status
Completed
 
Locations

A.O. Spedali Civili di Brescia

Brescia, Italy, 25100

Status
Completed
 
Locations

A.O. Carlo Poma

Mantova, Italy, 46100

Status
Terminated
 
Locations

Hadassah University Hospital Ein Kerem

Jerusalem, Israel, 91120

Status
Terminated
 
Locations

Poria Hospital

Tiberias, Israel, 31905

Status
Terminated
 
Locations

Krankenhaus der Elisabethinen Linz

Linz, Austria, 4010

Status
Terminated
 
Locations

1st Moscow Medical Academy named after I.M. Sechenov

Moscow, Russia, 119881

Status
Terminated
 
Locations

Regional State Medical Institution

Krasnoyarsk, Russia, 660022

Status
Terminated
 
Locations

Vseobecna nemocnica s poliklinikou Lucenec

Lucenec, Slovakia, 984 39

Status
Terminated
 
Locations

Medizinische Einrichtungen der Universität zu Köln

Köln, Germany, 50924

Status
Terminated
 
Locations

Klinikum der Friedrich-Schiller-Universität Jena

Jena, Germany, 07740

Status
Completed
 
Locations

Klinikum der Ernst-Moritz-Arndt-Universität

Greifswald, Germany, 17475

Status
Completed
 
Locations

Instytut Kardiologii

Warszawa, Poland, 04-628

Status
Terminated
 
Locations

IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ

Wroclaw, Poland, 50-981

Status
Completed
 
Locations

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80-211

Status
Terminated
 
Locations

Wielospecjalistyczny Szpital SP ZOZ

Zgorzelec, Poland, 59-900

Status
Terminated
 
Locations

Mito Medical Center

Higashiibaraki, Japan, 311-3193

Status
Terminated
 
Locations

Showa University Hospital

Shinagawa, Japan, 142-8666

Status
Terminated
 
Locations

Nippon Medical School Hospital

Bunkyo-ku, Japan, 113-8603

Status
Terminated
 
Locations

Nagoya Medical Center

Nagoya, Japan, 460-0001

Status
Terminated
 
Locations

A.O. Sant' Anna

San Fermo della Battaglia, Italy, 22020

Status
Terminated
 
Locations

A.O.U. S.G.Battista-Molinette

Torino, Italy, 10126

Status
Terminated
 
Locations

Akademiska Sjukhuset

Uppsala, Sweden, 751 85

Status
Terminated
 
Locations

Universitätsspital Zürich

Zürich, Switzerland, 8091

Status
Terminated
 
Locations

Ramathibodhi Hospital

Bangkok, Thailand, 10400

Status
Terminated
 
Locations

General Hospital Celje

Celje, Slovenia, 3000

Status
Terminated
 
Locations

Emergency Institute for Cardiovascular Diseases

Bucharest, Romania, 022328

Status
Terminated
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Status
Terminated
 
Locations

Lady Davis Carmel Medical Center

Haifa, Israel, 34362

Status
Terminated
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Terminated
 
Locations

Municipal Hospital N 4

Moscow, Russia, 115093

Status
Terminated
 
Locations

Municipal Hospital N 68

Moscow, Russia, 109263

Status
Terminated
 
Locations

Univerzitna nemocnica Martin

Martin, Slovakia, 036 59

Status
Terminated
 
Locations

Ospedale regionale di Lugano

Lugano, Switzerland, 6900

Status
Terminated
 
Locations

HUS, Meilahden sairaala

Helsinki, Finland, 00029

Status
Terminated
 
Locations

Oulun yliopistollinen sairaala

Oulu, Finland, 90220

Status
Terminated
 
Locations

Pramongkutklao Hospital

Bangkok, Thailand, 10400

Status
Terminated
 
Locations

Klinicni center

Ljubljana, Slovenia, 1000

Status
Terminated
 
Locations

Hospital Golnik

Golnik, Slovenia, 4204

Status
Terminated
 
Locations

Mercy Hospital Fairfield

Fairfield, United States, 45014

Status
Terminated
 
Locations

Slaskie Centrum Chorob Serca

Zabrze, Poland, 41-800

Status
Terminated
 
Locations

Wojewodzki Szpital Specjalistyczny im. Bieganskiego

Lodz, Poland, 91-347

Status
Terminated
 
Locations

Osaka Police Hospital

Osaka, Japan, 543-0035

Status
Terminated
 
Locations

Klinicka Bolnica Sestre Milosrdnice

Zagreb, Croatia, 10000

Status
Terminated
 
Locations

Klinicki Bolnicki Centar Zagreb

Zagreb, Croatia, 10000

Status
Terminated
 
Locations

Opca bolnica Sveti Duh

Zagreb, Croatia, 10000

Status
Terminated
 
Locations

Klinicki Centar Nis

Nis, Serbia, 18000

Status
Terminated
 
Locations

Institut za kardiovaskularne bolesti Dedinje

Beograd, Serbia, 11000

Status
Terminated
 
Locations

Klinicki centar Srbije

Beograd, Serbia, 11000

Status
Terminated
 
Locations

Institute za kardiovaskularne bolesti Vojvodine

Sremska Kamenica, Serbia, 21204

Status
Terminated
 
Locations

Louis Stokes VA Medical Center

Cleveland, United States, 44106

Status
Terminated
 
Locations

Drexel University College of Medicine

Philadelphia, United States, 19102

Status
Terminated
 
Locations

Valley Hospital

Ridgewood, United States, 07450

Status
Terminated
 
Locations

Jefferson Heart Institute

Philadelphia, United States, 19107

Status
Terminated
 
Locations

Wake Forest University School of Medicine

Winston-Salem, United States, 27157

Status
Terminated
 
Locations

Institutul Inimii de Urgenta pentru Boli Cardiovasculare

Cluj-Napoca, Romania, 400001

Status
Terminated
 

Trial Design