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)
Status and phase
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Treatments
Study type
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Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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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
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Subjects must have the clinical diagnosis of Congestive Heart Failure (CHF) made at least three months prior to enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
5 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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