Trial Condition(s):

Acute Heart Failure

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) (COMPOSE 2)

Bayer Identifier:

14663

ClinicalTrials.gov Identifier:

NCT01067859

EudraCT Number:

2009-014378-16

Terminated/Withdrawn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 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 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
5
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

University of Cincinnati

Cincinnati, United States, 45267-0542

Status
Terminated
 
Locations

Hôpital de Rangueil - Toulouse

TOULOUSE, France, 31403

Status
Terminated
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Terminated
 
Locations

Sanatorio Mitre

Buenos Aires, Argentina, C1039AAO

Status
Terminated
 
Locations

Beaumont Hospital

Dublin, Ireland, DUBLIN 9

Status
Terminated
 
Locations

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, Germany, 32545

Status
Completed
 
Locations

Herzzentrum Bad Krozingen

Bad Krozingen, Germany, 79189

Status
Terminated
 
Locations

DRK Kliniken Berlin - Köpenick

Berlin, Germany, 12559

Status
Terminated
 
Locations

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany, 61231

Status
Completed
 
Locations

Medizinische Einrichtungen der Heinrich-Heine-Universität

Düsseldorf, Germany, 40225

Status
Terminated
 
Locations

Hopital LARIBOISIERE

PARIS cedex 10, France, 75475

Status
Terminated
 
Locations

Centre Hospitalier Regional Henri Mondor

Creteil, France, 94010

Status
Terminated
 
Locations

OL Vrouwziekenhuis - Campus Aalst

AALST, Belgium, 9300

Status
Terminated
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Terminated
 
Locations

Fundación Favaloro

Buenos Aires, Argentina, 1078

Status
Terminated
 
Locations

LKH Graz West

Graz, Austria, 8020

Status
Terminated
 
Locations

Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

Status
Terminated
 
Locations

Massachusetts General Hospital

Boston, United States, 02114

Status
Terminated
 
Locations

Albert Einstein Health Network

Philadelphia, United States, 19141

Status
Terminated
 
Locations

University of Alabama at Birmingham

Birmingham, United States, 35294

Status
Terminated
 
Locations

Shands Jacksonville Medical Center

Jacksonville, United States, 32209

Status
Terminated
 
Locations

Ohio State University Medical Center

Columbus, United States, 43210

Status
Terminated
 
Locations

Hospital General “Dr Gustavo Baz Prada”

Mexico D.F., Mexico, 57000

Status
Terminated
 
Locations

Pulmocritic

Guadalajara, Mexico, 44670

Status
Terminated
 
Locations

Instituto Nacional de Cardiología "Ignacio Chávez"

México D.F., Mexico

Status
Terminated
 
Locations

Instituto Cardiovascular de Buenos Aires

Buenos Aires, Argentina, C1428DCO

Status
Terminated
 
Locations

Philippine Heart Centre

Quezon City, Philippines, 1102

Status
Terminated
 
Locations

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Mexico, 44280

Status
Terminated
 
Locations

Sanatorio Modelo Quilmes

Quilmes, Argentina

Status
Terminated
 
Locations

Hospital Italiano Buenos Aires

Buenos Aires, Argentina, C1181ACH

Status
Terminated
 

Trial Design