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

February 8, 2010
November 4, 2013
March 2010
January 2011   (final data collection date for primary outcome measure)
Pulmonary Capillary Wedge Pressure [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01065077 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Heart Failure
  • Drug: Cinaciguat (BAY58-2667)
    Infusion of 150 µg/h during 48h
  • Drug: Cinaciguat (BAY58-2667)
    Infusion of 100 µg/h during 48h
  • Drug: Cinaciguat (BAY58-2667)
    Infusion of 50 µg/h during 48h
  • Drug: Placebo
    Infusion of placebo during 48h
  • Experimental: Arm 1
    Intervention: Drug: Cinaciguat (BAY58-2667)
  • Experimental: Arm 2
    Intervention: Drug: Cinaciguat (BAY58-2667)
  • Experimental: Arm 3
    Intervention: Drug: Cinaciguat (BAY58-2667)
  • Placebo Comparator: Arm 4
    Intervention: Drug: Placebo
Gheorghiade M, Greene SJ, Filippatos G, Erdmann E, Ferrari R, Levy PD, Maggioni A, Nowack C, Mebazaa A; COMPOSE Investigators and Coordinators. Cinaciguat, a soluble guanylate cyclase activator: results from the randomized, controlled, phase IIb COMPOSE programme in acute heart failure syndromes. Eur J Heart Fail. 2012 Sep;14(9):1056-66. Epub 2012 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
February 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland,   United States,   Austria,   Croatia,   Finland,   Germany,   Israel,   Italy,   Japan,   Thailand,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Sweden,   Switzerland
 
NCT01065077
14560, 2009-014377-40
Yes
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP