BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

Phase 2

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (BAY59-7939)

• Registration Number: NCT00779064
• Lead Sponsor: Bayer

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2008-10-17
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2014-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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Exclusion Criteria

• Prior stroke and TIA
• Patients in whom anticoagulants are contraindicated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Rivaroxaban (BAY59-7939)	-
Arm 2	Rivaroxaban (BAY59-7939)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Each category of bleeding events and adverse event	Throughout treatment and followup period