Atrial Fibrillation
Conditions
Keywords
AFib, AF
Brief summary
This study is designed to evaluate the safety, tolerability and preliminary efficacy of vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration
Interventions
DRUGPlacebo comparator
Sponsors
Advanz Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
(partial list): * Subjects must have sustained, symptomatic atrial fibrillation for greater than 72 hours and less than 6 months duration * Subjects must have adequate anticoagulant therapy
Exclusion criteria
(partial list): * Subjects may not have Class III or Class IV congestive heart failure * Subjects may not have uncorrected electrolyte imbalance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All subjects who were exposed to the investigational medication were evaluated for safety. | Subjects were assessed for safety within Day 58 of dosing |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence of AF/AFL or withdrawal | Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing |
| Improvement in AF symptoms | Time to improvement in AF symptoms within Day 28 of dosing |
Countries
Canada, Denmark, Netherlands, United States
Outcome results
None listed