Conditions: Atrial Fibrillation Atrial Flutter
Keywords: Betrixaban MK-4448 nonvalvular atrial fibrillation
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 189
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to optimize drug exposure in the target population.

Detailed description:

Arms:
arm 1: Participants on betrixaban 30 mg and concomitant baseline amiodarone arm 2: Participants with lower weights arm 3: Participants with higher weights

Interventions: intervention 1: Amiodarone intervention 2: Betrixaban 60 mg intervention 3: Betrixaban 90 mg intervention 4: Betrixaban 30 mg
Intervention descriptions: intervention 1: Patients on Amiodarone intervention 2: Betrixaban 60 mg once a day with food on Day 0 through Day 25 intervention 3: Betrixaban 90 mg once a day with food on Day 0 through Day 25 intervention 4: Betrixaban 30 mg once a day with food on Day 0 through Day 25 with concomitant amiodarone treatment.

Protocol document: