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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)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01067859
First Posted: February 12, 2010
Last Update Posted: October 8, 2015
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.
Information provided by (Responsible Party):
Bayer
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Low Dose BAY58-2667 (25 µg/h, 10 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Cinaciguat (BAY58-2667)
Infusion of 25 µg/h during 48 hours
Experimental: Arm 2 Drug: Cinaciguat (BAY58-2667)
Infusion of 10 µg/h during 48 hours
Placebo Comparator: Arm 3 Drug: Placebo
Infusion of placebo during 48 hours

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067859


  Show 30 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01067859     History of Changes
Other Study ID Numbers: 14663
2009-014378-16 ( EudraCT Number )
First Submitted: February 11, 2010
First Posted: February 12, 2010
Last Update Posted: October 8, 2015
Last Verified: November 2014

Keywords provided by Bayer:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases