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The purpose of this study was to determine the efficacy and safety of intravenous RSD1235 in terminating recent onset atrial fibrillation(AF). Anti-arrhythmic drugs currently available to terminate AF have limited efficacy and safety. RSD1235 is a novel atrial selective anti-arrhythmic drug. This was a phase II, multi-centered, randomized, double-blinded, step-dose, placebo-controlled, parallel group study. Fifty-six patients from 15 U.S. and Canadian sites with AF of 3 to 72 h duration were randomized to one of two RSD1235 dose groups or to placebo. The two RSD1235 groups were RSD-1(0.5 mg/kg followed by 1 mg/kg)or RSD-2(2 mg/kg followed by 3 mg/kg), by intravenous infusion over 10 min; a second dose was given only if AF was present. The primary end point was termination of AF during infusion or within 30-min after the last infusion. Secondary end points included the number of patients in sinus rhythmat 0.5, 1, and 24 h post-last infusion and time to conversion to sinus rhythm. The RSD-2 dose showed significant differences over placebo in: 1)termination of AF(61%vs. 5%, p< 0.0005); 2)patients in sinus rhythm at 30 min(56%vs. 5%, p< 0.001); 3)sinus rhythmat 1 h(53%vs. 5%, p=0.0014); and 4)median time to conversion to SR(14 vs. 162 min, p=0.016). There were no serious adverse events related to RSD1235. RSD1235, a new atrial-selective anti-arrhyth-mic agent, appears to be efficacious and safe for converting recent onset AF to sinus rhythm.