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)



Status:Terminated
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2010
End Date:March 2011

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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)

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.


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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