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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)

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ClinicalTrials.gov Identifier: NCT01064037
Recruitment Status : Terminated
First Posted : February 8, 2010
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Heart Failure Heart Decompensation Drug: Cinaciguat (BAY58-2667) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
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 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)
Study Start Date : April 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Dyspnea VAS (using a visual analogue scale) [ Time Frame: 8 hours ]

Secondary Outcome Measures :
  1. Dyspnea assessment (Likert Scale) [ Time Frame: up to follow-up (30 - 35 days) ]
  2. Overall health status assessment (EQ-5D) [ Time Frame: up to follow-up (30 - 35 days) ]
  3. Changes in the dyspnea VAS at other time points [ Time Frame: Up to follow up visit ]
  4. Dyspnea assessment through Likert scale [ Time Frame: Up to follow up visit ]
  5. Overall health status assessment through EQ-5D Health Questionnaire [ Time Frame: Up to the follow-up visit ]
  6. Global clinical assessment by the physician [ Time Frame: At 8, 24, and 48 hours ]
  7. Change in concomitant medications [ Time Frame: During the treatment ]
  8. Safety variables [ Time Frame: Up to end of study ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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

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): NCT01064037


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01064037    
Other Study ID Numbers: 14836
2009-017082-39 ( EudraCT Number )
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2014
Keywords provided by Bayer:
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases