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

NCT01229254 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2023-08-07

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Portola Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-12-31
Completion
2011-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01229254 on ClinicalTrials.gov