BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

Bayer

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Rivaroxaban (BAY59-7939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00779064

11390

Details and patient eligibility

About

This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).

Enrollment: 36 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Rivaroxaban (BAY59-7939)

Drug: Rivaroxaban (BAY59-7939)

Arm 2

Experimental group

Treatment:

Drug: Rivaroxaban (BAY59-7939)

Drug: Rivaroxaban (BAY59-7939)