Trial Condition(s):

Heart Failure, Heart Decompensation

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) (COMPOSE EARLY)

Bayer Identifier:

14836

ClinicalTrials.gov Identifier:

NCT01064037

EudraCT Number:

2009-017082-39

Terminated/Withdrawn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 ovarectomy, 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
62
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

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Terminated
 
Locations

Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

Status
Terminated
 
Locations

Northampton General Hospital

Northampton, United Kingdom, NN1 5BD

Status
Terminated
 
Locations

Dorrington Medical Associates

Houston, United States, 77030

Status
Terminated
 
Locations

Northwestern Memorial Hospital

Chicago, United States, 60610

Status
Terminated
 
Locations

Chigasaki Tokushukai General Hospital

Chigasaki, Japan, 253-8558

Status
Terminated
 
Locations

Shizuoka Tokushukai Hospital

Shizuoka, Japan, 421-0193

Status
Terminated
 
Locations

Minamiwakayama Medical Center

Tanabe, Japan, 646-8558

Status
Completed
 
Locations

Kagoshima Medical Center

Kagoshima, Japan, 892-0853

Status
Terminated
 
Locations

Kanazawa Medical Center

Kanazawa, Japan, 920-8650

Status
Terminated
 
Locations

A.O.U. di Ferrara

Ferrara, Italy, 44100

Status
Completed
 
Locations

IRCCS San Raffaele Pisana

Roma, Italy, 00192

Status
Terminated
 
Locations

ASL 3 Genovese - Liguria

Pontedecimo, Italy, 16164

Status
Terminated
 
Locations

AUSL Lecce - Puglia

Casarano, Italy, 73042

Status
Terminated
 
Locations

HELIOS Klinikum Erfurt GmbH

Erfurt, Germany, 99089

Status
Completed
 
Locations

Asklepios Klinikum Melsungen

Melsungen, Germany, 34212

Status
Completed
 
Locations

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany, 41063

Status
Completed
 
Locations

Northwick Park Hospital

Harrow, United Kingdom, HA1 3UJ

Status
Terminated
 
Locations

University of Cincinnati Hospital Health Alliance

Cincinnati, United States, 45267

Status
Terminated
 
Locations

Wayne State University

Detroit, United States, 48201

Status
Completed
 
Locations

Vanderbilt University Medical Center

Nashville, United States, 37232-7240

Status
Terminated
 
Locations

The Cleveland Clinic

Cleveland, United States, 44195

Status
Terminated
 
Locations

Hôpital Jeanne d'Arc - Dommartin-les-toul

DOMMARTIN-LES-TOUL, France, 54201

Status
Completed
 
Locations

Centre Hospitalier Universitaire - Poitiers

POITIERS Cedex, France, 86021

Status
Terminated
 
Locations

Institut de cardiologie/Salpétrière

Paris cedex 13, France, 75013

Status
Terminated
 
Locations

10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Bydgoszcz, Poland, 85-681

Status
Completed
 
Locations

Szpital Specjalistyczny im. J. Dietla

Krakow, Poland, 31-121

Status
Completed
 
Locations

Maria Cecilia Hospital SpA

Cotignola, Italy, 48010

Status
Terminated
 
Locations

Hospital de Torrevieja

Torrevieja, Spain, 03186

Status
Terminated
 
Locations

Hospital Universitario "Virgen de la Arrixaca"

El Palmar, Spain, 30120

Status
Terminated
 
Locations

Kuils River Hospital

Kuils River, South Africa, 7580

Status
Completed
 
Locations

Clinical Projects Research SA

Worcester, South Africa, 6850

Status
Terminated
 
Locations

Union Hospital

Johannesburg, South Africa, 1449

Status
Completed
 
Locations

Facultni nemocnice Brno

Brno, Czech Republic, 625 00

Status
Completed
 
Locations

Kaplan Medical Center

Rehovot, Israel, 76100

Status
Terminated
 
Locations

Ziv Medical Center

Safed, Israel, 13100

Status
Completed
 
Locations

Western Galille Hospital Nahariya

Nahariya, Israel

Status
Terminated
 
Locations

Rambam Medical Center

Haifa, Israel, 31096

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Terminated
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-744

Status
Terminated
 
Locations

Portiuncula Hospital

Ballinasloe, Ireland

Status
Terminated
 
Locations

St Vincents University Hospital

Dublin, Ireland, DUBLIN 4

Status
Terminated
 
Locations

ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

Olsztyn, Poland, 10-228

Status
Completed
 
Locations

109 Szpital Wojskowy z przychodnia SPZOZ

Szczecin, Poland, 70-965

Status
Completed
 
Locations

National Hospital Organization Shizuoka Medical Center

Sunto, Japan, 411-8611

Status
Terminated
 
Locations

Matsumoto Medical Center Matsumoto Hospital

Matsumoto, Japan, 399-8701

Status
Terminated
 
Locations

A.O.U. Policlinico Consorziale

Bari, Italy, 70124

Status
Terminated
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Terminated
 
Locations

A.O.U. Policlinico Umberto I

Roma, Italy, 00161

Status
Terminated
 
Locations

Hospital Universitario Clinica Puerta de Hierro

Majadahonda, Spain, 28222

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Terminated
 
Locations

Olivedale Clinic

Johannesburg, South Africa, 2194

Status
Terminated
 
Locations

Fakultni nemocnice Motol

Praha 5, Czech Republic, 15006

Status
Terminated
 
Locations

Fakultni nemocnice Kralovske Vinohrady

Praha 10, Czech Republic, 10034

Status
Terminated
 
Locations

Nemocnice na Homolce

Praha 5, Czech Republic, 15030

Status
Completed
 
Locations

Regional Hospital Pardubice

Pardubice, Czech Republic, 532 03

Status
Terminated
 
Locations

St James' Hospital

Dublin, Ireland, 8

Status
Completed
 
Locations

Hopital Laval

Quebec, Canada, G1V 4G5

Status
Terminated
 
Locations

University of Calgary

Calgary, Canada, T2N 4Z6

Status
Terminated
 
Locations

Vancouver General Hospital

Vancouver, Canada, V5Z 1M9

Status
Terminated
 
Locations

Szent Istvan Hospital

Budapest, Hungary, H-1096

Status
Completed
 
Locations

Gottsegen Gyorgy National Cardiology Institute

Budapest, Hungary, 1096

Status
Completed
 
Locations

Bacs-Kiskun Country Hospital

Kecskemet, Hungary, 6000

Status
Terminated
 
Locations

Fejer megyei Szent Gyorgy Korhaz

Szekesfehervar, Hungary, 8000

Status
Terminated
 
Locations

Budai Irgalmasrendi Hospital

Budapest, Hungary, 1027

Status
Completed
 
Locations

Investigative Site

Jyväskylä, Finland

Status
Completed
 
Locations

Investigative Site

Turku, Finland

Status
Completed
 
Locations

Hôtel Dieu

Paris Cedex 04, France, 75181

Status
Terminated
 
Locations

Kliniken Nord und Süd

Nürnberg, Germany, 90471

Status
Terminated
 
Locations

Hôpital Lariboisière - Paris

PARIS, France, 75475

Status
Terminated
 

Trial Design