Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or flutter of recent onset to normal sinus rhythm.
Vanoxerine has important antiarrhythmic properties and may prove effective in converting AF/AFL to sinus rhythm in subjects with a history of AF. This is a prospective, randomized, double-blinded, placebo-controlled, dose-modifying study in subjects who have been in symptomatic AF or AFL for more than 3 hours and less than 7 days as dated by symptoms, who have AF/AFL documented on ECG at the time of study drug administration, and who satisfy the inclusion and exclusion criteria. The primary objectives of the trial are to evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo following oral administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
single oral dose
single oral dose
Unnamed facility
Ashkelon, Israel
Unnamed facility
Haifa, Israel
Unnamed facility
Nazareth, Israel
Unnamed facility
Safed, Israel
Unnamed facility
Moscow, Russia
Conversion to Sinus Rhythm
proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug
Time frame: baseline through 4 hours
Conversion to Sinus Rhythm
proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug
Time frame: baseline through 24 hours
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Unnamed facility
Saint Petersburg, Russia