A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Intravenous Tedisamil Sesquifumarate in the Rapid Conversion to Normal Sinus Rhythm in Female Subjects With Recent Onset Atrial Fibrillation

CompletadoFase 3ClinicalTrials.gov

ID: NCT00126022Tipo: INTERVENTIONALInicio: 1 de dic de 2004Fin estimado: 1 de mar de 2006

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Willing to sign informed consent before screening examinations are performed and before the study drug is administered
Females \> 18 years of age
Subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration \> 3 hours and \< 45 days) at the time of randomization
Subjects who are in no distress and hemodynamically stable (supine systolic blood pressure \> 90 mmHg and diastolic blood pressure \< 105 mmHg)

Criterios de exclusión

Pregnancy and lactation
Acute myocardial infarction and cerebrovascular accidents
Coronary syndromes and congestive heart failure (CHF) New York Heart Association (NYHA) IV
Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
Concurrent antiarrhythmic treatments

Intervenciones

drug

Tedisamil sesquifumarate

Ubicaciones

Site 2

Buenos Aires, Argentina

Site 3

Buenos Aires, Argentina

Site 5

Munro, Argentina

Site 4

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalSolvay Pharmaceuticals

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