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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01229254
First received: September 9, 2010
Last updated: September 13, 2017
Last verified: July 2017
Results First Received: July 21, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Atrial Fibrillation
Atrial Flutter
Interventions: Drug: Amiodarone
Drug: Betrixaban 60 mg
Drug: Betrixaban 90 mg
Drug: Betrixaban 30 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between 9Sep10 & 22Apr11, 189 patients were enrolled by 68 study centers in 2 countries (USA, Canada). Patients were enrolled to 1 of 3 treatment groups (betrixaban once daily 30, 60 or 90 mg) based on weight or use of amiodarone at screening. The study had an initial pharmacokinetics (PK) phase of 4 weeks and a safety extension phase of 20 weeks.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients weighing < 80 kg received daily betrixaban 60 mg, patients weighing ≥ 80 kg received daily betrixaban 90 mg, and patients on amiodarone at screening, regardless of weight, received daily betrixaban 30 mg. 241 patients were screened for study participation. Of these patients, 189 were enrolled and received at least 1 dose of study drug.

Reporting Groups
  Description
Betrixaban 30 mg (+Amiodarone) Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone
Betrixaban 60 mg (<80 kg) Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks
Betrixaban 90 mg (≥80 kg) Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks

Participant Flow:   Overall Study
    Betrixaban 30 mg (+Amiodarone)   Betrixaban 60 mg (<80 kg)   Betrixaban 90 mg (≥80 kg)
STARTED   42   74   73 
COMPLETED   27   58   61 
NOT COMPLETED   15   16   12 
Not Continuing Into Safety Extension                3                1                1 
Adverse Event                4                5                3 
Lost to Follow-up                3                0                1 
Physician Decision                0                3                0 
Protocol Violation                4                6                5 
Withdrawal by Subject                1                0                1 
Non-compliance with Study Drug                0                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled patients who took at least 1 dose of study medication

Reporting Groups
  Description
Betrixaban 30 mg (+Amiodarone) Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone
Betrixaban 60 mg (<80 kg) Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks
Betrixaban 90 mg (≥80 kg) Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks
Total Total of all reporting groups

Baseline Measures
   Betrixaban 30 mg (+Amiodarone)   Betrixaban 60 mg (<80 kg)   Betrixaban 90 mg (≥80 kg)   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   74   73   189 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.4  (9.87)   77.1  (7.12)   71.2  (9.21)   73.8  (8.98) 
Age, Customized 
[Units: Participants]
Count of Participants
       
<75 years   23   24   46   93 
>=75 years   19   50   27   96 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      19  45.2%      46  62.2%      16  21.9%      81  42.9% 
Male      23  54.8%      28  37.8%      57  78.1%      108  57.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Steady-state C12 hr on Days 14, 18, and 21 After Weight-based Dosing   [ Time Frame: Days 14, 18, and 21 of the PK period ]

2.  Secondary:   Steady-state C12 hr on Days 14, 18, and 21 After Weight and Amiodarone-based Dosing   [ Time Frame: Days 14, 18, and 21 of the PK period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Head of Clinical Development
Organization: Portola Pharmaceuticals, Inc.
phone: 650-246-7000



Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01229254     History of Changes
Other Study ID Numbers: 006-00
Study First Received: September 9, 2010
Results First Received: July 21, 2017
Last Updated: September 13, 2017