BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF) (COMPOSE 1)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01065077
First received: February 8, 2010
Last updated: November 4, 2013
Last verified: November 2013
  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.


Condition Intervention Phase
Acute Heart Failure
Drug: Cinaciguat (BAY58-2667)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY58-2667 (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pulmonary Capillary Wedge Pressure [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac index (CI) [ Time Frame: 8 hours and 48 hours ] [ Designated as safety issue: No ]
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Follow up (30 + 5 days) ] [ Designated as safety issue: No ]
  • Right atrial pressure (RAP) [ Time Frame: 8 hours and 48 hours ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Cinaciguat (BAY58-2667)
Infusion of 150 µg/h during 48h
Experimental: Arm 2 Drug: Cinaciguat (BAY58-2667)
Infusion of 100 µg/h during 48h
Experimental: Arm 3 Drug: Cinaciguat (BAY58-2667)
Infusion of 50 µg/h during 48h
Placebo Comparator: Arm 4 Drug: Placebo
Infusion of placebo during 48h

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065077

  Hide Study Locations
Locations
United States, New Jersey
Ridgewood, New Jersey, United States, 07450
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland, Ohio, United States, 44106
Fairfield, Ohio, United States, 45014
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19102
Philadelphia, Pennsylvania, United States, 19107
Austria
Linz, Oberösterreich, Austria, 4010
Wien, Austria, 1090
Croatia
Zagreb, Croatia, 10000
Finland
Helsinki, Finland, 00029
Oulu, Finland, 90220
Germany
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Köln, Nordrhein-Westfalen, Germany, 50924
Homburg, Saarland, Germany, 66424
Erfurt, Thüringen, Germany, 99089
Jena, Thüringen, Germany, 07740
Israel
Haifa, Israel, 34362
Jerusalem, Israel, 91120
Tiberias, Israel, 31905
Italy
San Fermo della Battaglia, Como, Italy, 22020
Brescia, Italy, 25100
Ferrara, Italy, 44100
Mantova, Italy, 46100
Torino, Italy, 10126
Japan
Nagoya, Aichi, Japan, 460-0001
Kure, Hiroshima, Japan, 737-0023
Higashiibaraki, Ibaraki, Japan, 311-3193
Kawasaki, Kanagawa, Japan, 216-8511
Omura, Nagasaki, Japan, 856-8562
Bunkyo-ku, Tokyo, Japan, 113-8603
Shinagawa, Tokyo, Japan, 142-8666
Osaka, Japan, 543-0035
Poland
Gdansk, Poland, 80-211
Lodz, Poland, 91-347
Warszawa, Poland, 02-507
Warszawa, Poland, 04-628
Wroclaw, Poland, 50-981
Zabrze, Poland, 41-800
Zgorzelec, Poland, 59-900
Romania
Bucharest, Romania, 022328
Cluj-Napoca, Romania, 400001
Russian Federation
Krasnoyarsk, Russian Federation, 660022
Moscow, Russian Federation, 119881
Moscow, Russian Federation, 115093
Moscow, Russian Federation, 109263
Serbia
Beograd, Serbia, 11000
Nis, Serbia, 18000
Sremska Kamenica, Serbia, 21204
Slovakia
Lucenec, Slovakia, 984 39
Martin, Slovakia, 036 59
Slovenia
Celje, Slovenia, 3000
Golnik, Slovenia, 4204
Ljubljana, Slovenia, 1000
Sweden
Göteborg, Sweden, 413 45
Uppsala, Sweden, 751 85
Switzerland
Lugano, Ticino, Switzerland, 6900
Zürich, Switzerland, 8091
Thailand
Bangkok, Thailand, 10400
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01065077     History of Changes
Other Study ID Numbers: 14560, 2009-014377-40
Study First Received: February 8, 2010
Last Updated: November 4, 2013
Health Authority: Austria: Agency for Health and Food Safety
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Croatia: Agency for Medicinal Product and Medical Devices
Russia: FSI Scientific Center of Expertise of Medical Application
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovenia: Agency for Medicinal Products - Ministry of Health
Thailand: Food and Drug Administration
United States: Food and Drug Administration
Italy: The Italian Medicines Agency
Romania: National Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Switzerland: Swissmedic
Sweden: Medical Products Agency

Keywords provided by Bayer:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014