BAY59-7939 Japanese in Atrial Fibrillation (2nd)

Bayer

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Xarelto (Rivaroxaban, BAY59-7939); Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00973323

12024

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Arm 1

Experimental group

Treatment:

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Arm 2

Experimental group

Treatment:

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Arm 3

Experimental group

Treatment:

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Arm 4

Active Comparator group

Treatment:

Drug: Warfarin