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:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01067859
First received: February 11, 2010
Last updated: February 18, 2014
Last verified: February 2014
  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 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 ] [ 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 (after 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: 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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067859

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01067859     History of Changes
Other Study ID Numbers: 14663, 2009-014378-16
Study First Received: February 11, 2010
Last Updated: February 18, 2014
Health Authority: Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Philippines: Department of Health
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Ireland: Irish Medicines Board
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Mexico: Federal Commission for Sanitary Risks Protection
United States: Food and Drug Administration

Keywords provided by Bayer:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014