A Phase 2 interventional study of Placebo and Vernakalant (oral) in Atrial Fibrillation, sponsored by Advanz Pharma. Completed at 152 sites in 24 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2008-12-18.
Sponsored by Advanz Pharma · Phase 2, Interventional, and Prevention
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).
3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's enrollment of 735 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Advanz Pharma is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo (b.i.d.)
Drug: Placebo
Vernakalant (oral), 150 mg (b.i.d.)
Drug: Vernakalant (oral)
Vernakalant (oral), 300 mg (b.i.d.)
Drug: Vernakalant (oral)
Vernakalant (oral), 500 mg (b.i.d.)
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Also known as: RSD1235-SR
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
Showing the first 100 of 152 sites across 24 countries.
This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Advanz Pharma