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BAY59-7939, Japanese Phase II in Atrial Fibrillation Trial Status

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00779064
First received: October 17, 2008
Last updated: October 23, 2008
Last verified: October 2008

October 17, 2008
October 23, 2008
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
BAY59-7939, Japanese Phase II in Atrial Fibrillation Trial Status
BAY59-7939, Japanese Phase II in Atrial Fibrillation Trial 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
57
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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00779064
11390
No
Head Clinical Pharmacology, Bayer Yakuhin LTD
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2008

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