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) - NCT01064037-48201(Clinical Trial 592542)
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Detroit |
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State:
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MI |
| Zip Code: |
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48201 |
| Conditions: |
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Heart Failure - Heart Decompensation |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 18, 2011 |
Modifications to
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above to view all information about this clinical trial. |
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