BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

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 ovariectomy, and women with a hysterectomy

• Subjects must have the clinical diagnosis of 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