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Completed

NCT Number: NCT00973245

BAY59-7939 in Atrial Fibrillation Once Daily (OD)

This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subjects with non-valvular atrial fibrillation (originally described in Japanese).

Completed

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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

Chikushino-shi, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Japanese subjects with non-valvular AF who met all of the following criteria:

  • Male subjects aged 20 years or older and postmenopausal female subjects
  • Subjects with 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
  • Subjects who were at risk for stroke as follows:
  • Subjects with at least one risk factor for thromboembolism (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).
  • Subjects aged 60 years old and above regardless of the existence of above risk factors.

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.

Treatment and study plan

Xarelto (Rivaroxaban, BAY59-7939)

Drug

10mg od

Warfarin

Drug

Dose-adjusted warfarin based on target INR values

Primary outcomes

  1. (Safety) Incidence of bleeding

    Time frame: Throughout treatment and followup period

  2. (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST

    Time frame: Day 14 and Day 28

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

BAY 59-7939 (Factor Xa Inhibitor) Phase II Once Daily Dose Study in Patients With Atrial Fibrillation

Important dates

Study start
2006
Study completion
2007
First posted
Sep 9, 2009
Registry last updated
Dec 30, 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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