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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Acute Heart Failure

In brief

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.

Key facts

Study ID

NCT01065077

Run by

Bayer

People needed

12

Starts

2010-03-01

Expected to finish

2011-02-01

Last updated by the study team

2015-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Winston-Salem, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Fairfield, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Vienna, State of Vienna, Austria
• Study site — Linz, Upper Austria, Austria
• Study site — Zagreb, Croatia
• Study site — Helsinki, Finland
• Study site — Oulu, Finland
• Study site — Greifswald, Mecklenburg-Vorpommern, Germany
• Study site — Cologne, North Rhine-Westphalia, Germany
• Study site — Homburg, Saarland, Germany
• Study site — Erfurt, Thuringia, Germany
• Study site — Jena, Thuringia, Germany
• Study site — Haifa, Israel, Israel
• Study site — Jerusalem, Israel, Israel
• Study site — Tiberias, Israel, Israel
• Study site — San Fermo della Battaglia, Como, Italy
• Study site — Brescia, Italy
• Study site — Ferrara, Italy
• Study site — Mantua, Italy
• Study site — Torino, Italy
• Study site — Nagoya, Aichi-ken, Japan
• Study site — Ridgewood, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.