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BAY59-7939 Japanese in Atrial Fibrillation (2nd)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00973323
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 7, 2009
First Posted Date  ICMJE September 9, 2009
Last Update Posted Date December 30, 2014
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
  • (Safety) Incidence of bleeding [ Time Frame: Throughout treatment and followup period ]
  • (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST [ Time Frame: Day 14 and Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BAY59-7939 Japanese in Atrial Fibrillation (2nd)
Official Title  ICMJE BAY 59-7939 (Factor Xa Inhibitor) Phase II Low Dose Study in Patients With Atrial Fibrillation
Brief Summary This study was a randomized, parallel group, open label trial using warfarin as comparator. Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups (originally described in Japanese).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: Xarelto (Rivaroxaban, BAY59-7939)
    2.5mg bid
  • Drug: Xarelto (Rivaroxaban, BAY59-7939)
    5mg bid
  • Drug: Xarelto (Rivaroxaban, BAY59-7939)
    10mg bid
  • Drug: Warfarin
    Dose-adjusted warfarin based on target INR values
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Xarelto (Rivaroxaban, BAY59-7939)
  • Experimental: Arm 2
    Intervention: Drug: Xarelto (Rivaroxaban, BAY59-7939)
  • Experimental: Arm 3
    Intervention: Drug: Xarelto (Rivaroxaban, BAY59-7939)
  • Active Comparator: Arm 4
    Intervention: Drug: Warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2014)
100
Original Actual Enrollment  ICMJE
 (submitted: September 8, 2009)
121
Actual Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese subjects with non-valvular AF who met all of the following criteria:

    • Persistent or paroxysmal non-valvular AF with >/=2 episodes before enrollment, at least 1 of which had been verified by ECG recording within 4 weeks before randomization
    • Male subjects aged 20 years or older and postmenopausal female subjects
    • Subjects with at least one risk factor for thromboembolism or aged 60 years or older (Risk factor for thromboembolism: hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).

Exclusion Criteria:

  • History or presence of stroke or transient ischemic attack.
  • History of intracerebral hemorrhage.
  • History or presence of bleeding at randomization; intraocular or gastrointestinal bleeding within the last 6 months prior to randomization.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00973323
Other Study ID Numbers  ICMJE 12024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP