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)

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

NCT01067859

Run by

Bayer

People needed

5

Starts

2010-03-01

Expected to finish

2010-11-01

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 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

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 — Birmingham, Alabama, United States
• Study site — Jacksonville, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Quilmes, Buenos Aires, Argentina
• Study site — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Study site — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Study site — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Study site — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Study site — Graz, Styria, Austria
• Study site — Innsbruck, Tyrol, Austria
• Study site — Aalst, Belgium
• Study site — Bruxelles - Brussel, Belgium
• Study site — Leuven, Belgium
• Study site — Créteil, France
• Study site — Paris, France
• Study site — Toulouse, France
• Study site — Bad Krozingen, Baden-Wurttemberg, Germany
• Study site — Bad Nauheim, Hesse, Germany
• Study site — Bad Oeynhausen, North Rhine-Westphalia, Germany
• Study site — Düsseldorf, North Rhine-Westphalia, Germany
• Study site — Berlin, State of Berlin, Germany
• Study site — Dublin, Ireland

Full record on ClinicalTrials.gov

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