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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01067859
Recruitment Status : Terminated
First Posted : February 12, 2010
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE February 11, 2010
First Posted Date  ICMJE February 12, 2010
Last Update Posted Date October 8, 2015
Study Start Date  ICMJE March 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2010)
Pulmonary Capillary Wedge Pressure [ Time Frame: 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2010)
  • Cardiac index (CI) [ Time Frame: 8 hours and 48 hours ]
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Follow up (after 30+5 days) ]
  • Right atrial pressure (RAP) [ Time Frame: 8 hours and 48 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of Low Dose BAY58-2667 (25 µg/h, 10 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Heart Failure
Intervention  ICMJE
  • Drug: Cinaciguat (BAY58-2667)
    Infusion of 25 µg/h during 48 hours
  • Drug: Cinaciguat (BAY58-2667)
    Infusion of 10 µg/h during 48 hours
  • Drug: Placebo
    Infusion of placebo during 48 hours
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Cinaciguat (BAY58-2667)
  • Experimental: Arm 2
    Intervention: Drug: Cinaciguat (BAY58-2667)
  • Placebo Comparator: Arm 3
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 18, 2014)
5
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2010)
60
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   France,   Germany,   Ireland,   Mexico,   Philippines,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01067859
Other Study ID Numbers  ICMJE 14663
2009-014378-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2014

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