A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Tolerability of Intravenous Tonapofylline in Subjects With Acute Decompensated Heart Failure and Renal Insufficiency

CompletadoFase 3ClinicalTrials.gov

ID: NCT00709865Tipo: INTERVENTIONALInicio: 31 de jul de 2008Fin estimado: 31 de dic de 2009

Cardiología Nefrología

Traducción no disponible, mostrando original

Resumen

The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Previous diagnosis of heart failure.
Must have ADHF, requiring hospitalization, with clinical evidence for volume overload

Criterios de exclusión

History of an allergic reaction to any xanthine-containing substance.
History of seizure
History of stroke
Myocardial infarction
Uncorrected hemodynamically significant primary valvular disease or known Obstructive or restrictive cardiomyopathy.
Serious systemic infection
Major surgical procedures within 30 days
Acute coronary syndrome
Cardiogenic shock
Baseline body weight \>150 kg
Participation in any other investigational study of drugs or devices within 30 days prior to Screening
Nursing mothers, pregnant women, or women planning on becoming pregnant during the study
Presence of any clinically significant condition that might interfere with optimal safe participation in this study

Intervenciones

drug

tonapofylline

drug

Placebo

Ubicaciones

Buenos Aires, BUE, Argentina

Capital Federal, CBA, Argentina

Corrientes, COR, Argentina

Córdoba, CRD, Argentina

Villa Cabrera, CRD, Argentina

Santa Fe, SFE, Argentina

San Luis, SLS, Argentina

San Miguel de Tucumán, TUC, Argentina

Capital Federal, Argentina

Patrocinadores

PrincipalBiogen

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