Conditions: Symptomatic Atrial Fibrillation Atrial Flutter
Keywords: vanoxerine atrial fibrillation atrial flutter a-fib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 104
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: vanoxerine HCl 200mg single dose (2x 100 mg oral capsule) arm 2: placebo to match vanoxerine oral capsule arm 3: vanoxerine HCl 300 mg single dose (3x 100mg oral capsules) arm 4: vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)

Interventions: intervention 1: Vanoxerine intervention 2: Placebo
Intervention descriptions: intervention 1: single oral dose intervention 2: single oral dose

Protocol document: