To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration \> 72 hours and \< 6 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
735
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Time to first documented recurrence of symptomatic sustained AF.
Time frame: Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing
Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events
Time frame: Safety assessments within Day 120 of dosing
Time to first documented recurrence of symptomatic or asymptomatic sustained AF
Time frame: Time to first documented recurrence of symptomatic or asymptomatic sustained AF within 90 days of dosing
Time to first documented recurrence of symptomatic AF
Time frame: Time to first documented recurrence of symptomatic AF within 90 days of dosing
Time to first documented recurrence of symptomatic or asymptomatic AF
Time frame: Time to first documented recurrence of symptomatic or asymptomatic AF within 90 days of dosing
Proportion of subjects in sinus rhythm on Day 90.
Time frame: Proportion of subjects in sinus rhythm on Day 90 of dosing
Improvement in AF symptoms as assessed by an AF symptom checklist.
Time frame: Improvement in AF symptoms as assessed by an AF symptom checklist within Day 90 of dosing
Improvement in QOL as measured by SF-36
Time frame: Improvement in QOL as measured by SF-36 within Day 90 of dosing
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