A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) (COMPOSE EARLY)

This study has been terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01064037
First received: February 4, 2010
Last updated: May 13, 2013
Last verified: May 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
Heart Failure
Heart Decompensation
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 BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Dyspnea VAS (using a visual analogue scale) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dyspnea assessment (Likert Scale) [ Time Frame: up to follow-up (30 - 35 days) ] [ Designated as safety issue: No ]
  • Overall health status assessment (EQ-5D) [ Time Frame: up to follow-up (30 - 35 days) ] [ Designated as safety issue: No ]
  • Changes in the dyspnea VAS at other time points [ Time Frame: Up to follow up visit ] [ Designated as safety issue: No ]
  • Dyspnea assessment through Likert scale [ Time Frame: Up to follow up visit ] [ Designated as safety issue: No ]
  • Overall health status assessment through EQ-5D Health Questionnaire [ Time Frame: Up to the follow-up visit ] [ Designated as safety issue: No ]
  • Global clinical assessment by the physician [ Time Frame: At 8, 24, and 48 hours ] [ Designated as safety issue: No ]
  • Change in concomitant medications [ Time Frame: During the treatment ] [ Designated as safety issue: No ]
  • Safety variables [ Time Frame: Up to end of study ] [ Designated as safety issue: Yes ]
    Frequency of TEAEs (AEs were considered to be treatment emergent if they started after the start of sthe study drug infusion to up to 2 calendar days after the end of the study drug infusion); treatment-emergent serious adverse events (SAEs); deaths; evaluation of renal and cardiac function; Change in heart rate; Change in systolic and diastolic blood pressure; Laboratory parameters (including parameters related to hematology, clinical chemistry, urinalysis, and biomarkers); ECG assessment


Enrollment: 62
Study Start Date: April 2010
Study Completion Date: March 2011
Primary Completion Date: February 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 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 ovarectomy, 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: NCT01064037

  Show 70 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01064037     History of Changes
Other Study ID Numbers: 14836, 2009-017082-39
Study First Received: February 4, 2010
Last Updated: May 13, 2013
Health Authority: Finland: Finnish Medicines Agency
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: National Institute of Health Sciences
Korea: Food and Drug Administration
Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
South Africa: Human Research Ethics Committee
Poland: Ministry of Health
Czech Republic: State Institute for Drug Control
Ireland: Irish Medicines Board
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