BAY59-7939 Japanese in Atrial Fibrillation (2nd) | NCT00973323

Studies
BAY59-7939 Japanese in Atrial Fibrillation (2nd)

NCT00973323

Sponsor

Bayer

Status

Completed

Last Update Posted

Dec 30, 2014Estimated

Enrollment

100Actual

Phase

Phase 2

Conditions

Atrial Fibrillation

Interventions

Xarelto (Rivaroxaban, BAY59-7939)
Xarelto (Rivaroxaban, BAY59-7939)
Xarelto (Rivaroxaban, BAY59-7939)
Warfarin

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Mar 2006Actual

First Submitted Date

Sep 7, 2009

First Submission Date that Met QC Criteria

Sep 8, 2009

First Posted Date

Sep 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2014

Last Update Posted Date

Dec 30, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arm 1	Experimental	Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 2	Experimental	Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 3	Experimental	Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 4	Active Comparator	Drug: Warfarin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xarelto (Rivaroxaban, BAY59-7939)	Drug	2.5mg bid	Arm 1
Xarelto (Rivaroxaban, BAY59-7939)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
(Safety) Incidence of bleeding		Throughout treatment and followup period
(PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST		Day 14 and Day 28

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069552	Rivaroxaban
D014859	Warfarin

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Fukui-shi	Fukui	910-0005	Japan