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BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Rivaroxaban (BAY59-7939)
Rivaroxaban (BAY59-7939)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)

Secondary Outcome Measures

Each category of bleeding events and adverse event

Full Information

First Posted
October 17, 2008
Last Updated
December 23, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00779064
Brief Title
BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status
Official Title
BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (BAY59-7939)
Intervention Description
10mg BID, Semi-sequential, dose escalation.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (BAY59-7939)
Intervention Description
20mg BID, Semi-sequential, dose escalation.
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)
Time Frame
Day 14 and 28
Secondary Outcome Measure Information:
Title
Each category of bleeding events and adverse event
Time Frame
Throughout treatment and followup period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
800-0057
Country
Japan
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-8577
Country
Japan
City
Onga
State/Province
Fukuoka
ZIP/Postal Code
807-0051
Country
Japan
City
Kitahiroshima
State/Province
Hokkaido
ZIP/Postal Code
061-1134
Country
Japan
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-8511
Country
Japan
City
Kawachinagano
State/Province
Osaka
ZIP/Postal Code
586-8521
Country
Japan
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
City
Fukuoka
ZIP/Postal Code
811-0213
Country
Japan
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

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