NCT00973323

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_2 atrial-fibrillation

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2 atrial-fibrillation

Geographic Reach
1 country

10 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

September 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2009

Completed
2 days 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 7, 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 3

EXPERIMENTAL
Drug: Xarelto (Rivaroxaban, BAY59-7939)

Arm 4

ACTIVE COMPARATOR
Drug: Warfarin

Interventions

Xarelto (Rivaroxaban, BAY59-7939)DRUG

2.5mg bid

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:
  • 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).

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 (10)

Unknown Facility

Fukui-shi, Fukui, 910-0005, Japan

Location

Unknown Facility

Kurume, Fukuoka, 830-8577, Japan

Location

Unknown Facility

Maebaru-chūō, Fukuoka, 819-1104, Japan

Location

Unknown Facility

Kitahiroshima, Hokkaido, 061-1134, Japan

Location

Unknown Facility

Kushiro, Hokkaido, 085-0831, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 064-0807, Japan

Location

Unknown Facility

Nomi, Ishikawa-ken, 923-1100, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 227-0046, Japan

Location

Unknown Facility

Ōita, Oita Prefecture, 870-0192, Japan

Location

Unknown Facility

Tokorozawa, Saitama, 359-1141, 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 7, 2009

First Posted

September 9, 2009

Study Start

September 1, 2005

Study Completion

March 1, 2006

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

JP(10)