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BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00779064
First Posted: October 24, 2008
Last Update Posted: December 25, 2014
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.
Information provided by (Responsible Party):
Bayer
October 17, 2008
October 24, 2008
December 25, 2014
July 2004
June 2005   (Final data collection date for primary outcome measure)
Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R) [ Time Frame: Day 14 and 28 ]
Same as current
Complete list of historical versions of study NCT00779064 on ClinicalTrials.gov Archive Site
Each category of bleeding events and adverse event [ Time Frame: Throughout treatment and followup period ]
Same as current
Not Provided
Not Provided
 
BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status
BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status
This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Atrial Fibrillation
  • Drug: Rivaroxaban (BAY59-7939)
    10mg BID, Semi-sequential, dose escalation.
  • Drug: Rivaroxaban (BAY59-7939)
    20mg BID, Semi-sequential, dose escalation.
  • Experimental: Arm 1
    Intervention: Drug: Rivaroxaban (BAY59-7939)
  • Experimental: Arm 2
    Intervention: Drug: Rivaroxaban (BAY59-7939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2005
June 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 20 years or older
  • Japanese male or female
  • Non- valvular atrial fibrillation documented by ECG
  • Patients aged 60 years and older or with a risk of stroke

Exclusion Criteria:

  • Prior stroke and TIA
  • Patients in whom anticoagulants are contraindicated
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00779064
11390
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2014

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