NCT00973245

Brief Summary

This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subjects with non-valvular atrial fibrillation (originally described in Japanese).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_2 atrial-fibrillation

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_2 atrial-fibrillation

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

First QC Date

September 8, 2009

Last Update Submit

December 26, 2014

Conditions

Atrial Fibrillation

Keywords

BAY59-7939RivaroxabanNon-valvular atrial fibrillationJapanese PatientsPhase II

Outcome Measures

Primary Outcomes (2)

  • (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

Study Arms (4)

Arm 1

EXPERIMENTAL
Drug: Xarelto (Rivaroxaban, BAY59-7939)

Arm 2

EXPERIMENTAL
Drug: Xarelto (Rivaroxaban, BAY59-7939)

Arm 4

ACTIVE COMPARATOR
Drug: Warfarin

Arm 3

EXPERIMENTAL
Drug: Xarelto (Rivaroxaban, BAY59-7939)

Interventions

Xarelto (Rivaroxaban, BAY59-7939)DRUG

10mg od

Arm 1
WarfarinDRUG

Dose-adjusted warfarin based on target INR values

Arm 4

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese subjects with non-valvular AF who met all of the following criteria:
  • Male subjects aged 20 years or older and postmenopausal female subjects
  • Subjects with 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
  • Subjects who were at risk for stroke as follows:
  • Subjects with at least one risk factor for thromboembolism (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).
  • Subjects aged 60 years old and above regardless of the existence of above risk factors.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Chikushino-shi, Fukuoka, 818-8516, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 810-8798, Japan

Location

Unknown Facility

Nōgata, Fukuoka, 822-0026, Japan

Location

Unknown Facility

Asahikawa, Hokkaido, 078-8214, Japan

Location

Unknown Facility

Kobe, Hyōgo, 651-0073, Japan

Location

Unknown Facility

Takarazuka, Hyōgo, 665-0022, Japan

Location

Unknown Facility

Kuwana, Mie-ken, 511-0068, Japan

Location

Unknown Facility

Sendai, Miyagi, 980-0803, Japan

Location

Unknown Facility

Sendai, Miyagi, 980-0871, Japan

Location

Unknown Facility

Tokorozawa, Saitama, 359-1141, Japan

Location

Unknown Facility

Shinagawa-ku, Tokyo, 141-0001, Japan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

RivaroxabanWarfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

July 1, 2006

Study Completion

January 1, 2007

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

JP(11)