A PHASE III PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, TOLERANCE AND EFFICACY STUDY OF RSD1235 IN SUBJECTS WITH ATRIAL FIBRILLATION OR ATRIAL FLUTTER

Update Il y a 4 ans
Reference: EUCTR2004-000984-81

Woman and Man

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Extract

To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of AF or AFL to SR. Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to SR for a minimum of 1-minute within Hour 1.5 from the start of the first infusion (Time 0).


Inclusion criteria

  • Arrhythmias are abnormal rhythms of the heart. The term arrhythmia refers to a deviation from the normal sequence of initiation and conduction of electrical impulses, which cause the heart to beat. Arrhythmias may occur in the atria or the ventricles. Atrial arrhythmias are widespread and relatively benign