NCT01229254

Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Portola Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Atrial Fibrillation
• Atrial Flutter

Interventions

Type	Name	Description
DRUG	Amiodarone	Patients on Amiodarone
DRUG	Betrixaban 60 mg	Betrixaban 60 mg once a day with food on Day 0 through Day 25
DRUG	Betrixaban 90 mg	Betrixaban 90 mg once a day with food on Day 0 through Day 25
DRUG	Betrixaban 30 mg	Betrixaban 30 mg once a day with food on Day 0 through Day 25 with concomitant amiodarone treatment.

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-12-01
• Completion: 2011-04-01
• First posted: 2010-10-27
• Last updated: 2023-08-07
• Results posted: 2017-09-18