A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of Low Dose BAY58-2667 (25 µg/h, 10 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

TerminadoFase 2ClinicalTrials.gov

ID: NCT01067859Tipo: INTERVENTIONALInicio: 1 de mar de 2010Fin estimado: 1 de nov de 2010

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Cinaciguat (BAY58-2667)

Infusion of 25 µg/h during 48 hours

drug

Cinaciguat (BAY58-2667)

Infusion of 10 µg/h during 48 hours

drug

Placebo

Infusion of placebo during 48 hours

Ubicaciones

Quilmes, Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Patrocinadores

PrincipalBayer

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