BAY59-7939, Japanese Phase II in Atrial FibrillationTrial... | NCT00779064

Studies
BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

NCT00779064

Sponsor

Bayer

Status

Completed

Last Update Posted

Dec 25, 2014Estimated

Enrollment

36Actual

Phase

Phase 2

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban (BAY59-7939)
Rivaroxaban (BAY59-7939)

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

Jul 2004

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Oct 17, 2008

First Submission Date that Met QC Criteria

Oct 23, 2008

First Posted Date

Oct 24, 2008Estimated

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 23, 2014

Last Update Posted Date

Dec 25, 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 is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (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

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Rivaroxaban (BAY59-7939)
Arm 2	Experimental		Drug: Rivaroxaban (BAY59-7939)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban (BAY59-7939)	Drug	10mg BID, Semi-sequential, dose escalation.	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)		Day 14 and 28

Secondary Outcomes

Measure	Description	Time Frame
Each category of bleeding events and adverse event		Throughout treatment and followup period

Other Outcomes

Not provided

Eligibility Module

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

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

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
		Fukuoka	Fukuoka	811-0213	Japan