Trial · NCT01229254

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

NCT01229254, Phase 2, Completed, Portola Pharmaceuticals; results first posted 2017-09-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter. Trials, record NCT01229254. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01229254

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter
NCT number: NCT01229254
Status: Completed
Phases: Phase 2
Enrollment: 189 participants, actual
Lead sponsor: Portola Pharmaceuticals
Conditions: Atrial Fibrillation, Atrial Flutter
Interventions: Amiodarone, Betrixaban 60 mg, Betrixaban 90 mg, Betrixaban 30 mg
First posted: 2010-10-27
Last updated: 2023-08-07
Results first posted: 2017-09-18

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Steady-state C12 hr on Days 14, 18, and 21 After Weight-based Dosing	Days 14, 18, and 21 of the PK period	Betrixaban PK concentration at 12 hr on Days 14, 18, and 21 in low and high weight groups
Secondary	Steady-state C12 hr on Days 14, 18, and 21 After Weight and Amiodarone-based Dosing	Days 14, 18, and 21 of the PK period	Betrixaban PK concentration at 12 hr on Days 14, 18, and 21 in amiodarone, low and high weight groups

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Steady-state C12 hr on Days 14, 18, and 21 After Weight-based Dosing	Days 14, 18, and 21 of the PK period	Per protocol analysis set, which includes all allocated patients who received at least one dose of study treatment and who were ≥ 90% compliant with study treatment, took study treatment within 24 hours prior to steadystate blood sampling, had at least two post steady-state blood samples collected, and not on amiodarone.	ng/mL	GEOMETRIC_LEAST_SQUARES_MEAN
SECONDARY	Steady-state C12 hr on Days 14, 18, and 21 After Weight and Amiodarone-based Dosing	Days 14, 18, and 21 of the PK period	Full Analysis Set population, which includes all patients who received at least one dose of study treatment within 24 hours prior to steady-state (SS) blood sampling, were ≥ 90% compliant with treatment, and had at least one post SS sample. The endpoint was to summarize the SS C12 hr concentration across treatments and time points as a single arm.	ng/mL	GEOMETRIC_LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Steady-state C12 hr on Days 14, 18, and 21 After Weight-based Dosing	Betrixaban 60 mg (<80 kg)	7.870	90% Confidence Interval 6.654 to 9.307	ng/mL
Steady-state C12 hr on Days 14, 18, and 21 After Weight-based Dosing	Betrixaban 90 mg (≥80 kg)	10.517	90% Confidence Interval 8.903 to 12.423	ng/mL
Steady-state C12 hr on Days 14, 18, and 21 After Weight and Amiodarone-based Dosing	Betrixaban	9.498	90% Confidence Interval 8.586 to 10.507	ng/mL

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Betrixaban 30 mg (+Amiodarone)	42
Overall Study	STARTED	Betrixaban 60 mg (<80 kg)	74
Overall Study	STARTED	Betrixaban 90 mg (≥80 kg)	73
Overall Study	COMPLETED	Betrixaban 30 mg (+Amiodarone)	27
Overall Study	COMPLETED	Betrixaban 60 mg (<80 kg)	58
Overall Study	COMPLETED	Betrixaban 90 mg (≥80 kg)	61
Overall Study	NOT COMPLETED	Betrixaban 30 mg (+Amiodarone)	15
Overall Study	NOT COMPLETED	Betrixaban 60 mg (<80 kg)	16
Overall Study	NOT COMPLETED	Betrixaban 90 mg (≥80 kg)	12

Source ClinicalTrials.gov

Adverse events111

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Betrixaban 30 mg (+Amiodarone)	2	42
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Betrixaban 60 mg (<80 kg)	3	74
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Betrixaban 90 mg (≥80 kg)	6	73
other	Upper respiratory tract infection	Infections and infestations	Betrixaban 30 mg (+Amiodarone)	3	42
other	Upper respiratory tract infection	Infections and infestations	Betrixaban 60 mg (<80 kg)	1	74
other	Upper respiratory tract infection	Infections and infestations	Betrixaban 90 mg (≥80 kg)	6	73
other	Dizziness	Nervous system disorders	Betrixaban 30 mg (+Amiodarone)	0	42
other	Dizziness	Nervous system disorders	Betrixaban 60 mg (<80 kg)	9	74
other	Dizziness	Nervous system disorders	Betrixaban 90 mg (≥80 kg)	5	73
other	Fatigue	General disorders	Betrixaban 30 mg (+Amiodarone)	3	42

1 to 10 of 111Source ClinicalTrials.gov

See all 111 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Betrixaban 30 mg (+Amiodarone)
Total, all-cause mortality	Betrixaban 60 mg (<80 kg)
Total, all-cause mortality	Betrixaban 90 mg (≥80 kg)
Total, other adverse events	Betrixaban 30 mg (+Amiodarone)	18	42
Total, other adverse events	Betrixaban 60 mg (<80 kg)	34	74
Total, other adverse events	Betrixaban 90 mg (≥80 kg)	35	73
Total, serious adverse events	Betrixaban 30 mg (+Amiodarone)	6	42
Total, serious adverse events	Betrixaban 60 mg (<80 kg)	13	74
Total, serious adverse events	Betrixaban 90 mg (≥80 kg)	6	73

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01229254

GET https://conductscience.org/api/trials/v1/NCT01229254/events?page=2

API reference For AI assistants