At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 189 enrolled
Drug / intervention
Amiodarone +3 moredrug
Likely dose
Betrixaban 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Open-label, Dose Exposure Confirmation Study to Evaluate the Pharmacokinetics and Safety and Tolerability of Betrixaban (MK-4448) in Adult Patients With Nonvalvular Atrial Fibrillation or Atrial Flutter
In Brief
A Phase 2 clinical trial evaluating Amiodarone, Betrixaban 60 mg, and 2 other interventions for Atrial Fibrillation and Atrial Flutter. Completed, enrolled 189 participants.
Detailed Summary
The primary purpose of this study is to optimize drug exposure in the target population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Atrial Flutter
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedOct 2010
Primary CompletionDec 2010
Study CompletionApr 2011
TodayJul 2026
First PostedOct 27, 2010
Enrollment StartSep 1, 2010
Primary CompletionDec 1, 2010
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.7 years ago
Interventions
Amiodaronedrug
Patients on Amiodarone
Betrixaban 60 mgdrug
Betrixaban 60 mg once a day with food on Day 0 through Day 25
Betrixaban 90 mgdrug
Betrixaban 90 mg once a day with food on Day 0 through Day 25
Betrixaban 30 mgdrug
Betrixaban 30 mg once a day with food on Day 0 through Day 25 with concomitant amiodarone treatment.