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Completed

NCT Number: NCT00779064

BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (BAY59-7939)

Drug

10mg BID, Semi-sequential, dose escalation.

Primary outcomes

  1. Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)

    Time frame: Day 14 and 28

Secondary outcomes

  1. Each category of bleeding events and adverse event

    Time frame: Throughout treatment and followup period

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Oct 24, 2008
Registry last updated
Dec 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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