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Completed

NCT Number: NCT01028950

YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness

To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chugoku, 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

  • Patient is hospitalized within 2 days before the study and has more than 1 basic VTE risks
  • Complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization
  • Written informed consent obtained

Exclusion criteria

  • Subject has history of deep vein thrombosis and/or pulmonary embolism
  • Subject has a hemorrhagic disorder and/or coagulation disorder
  • Subject has had clinically important bleeding occurred within 90 days prior to obtaining informed consent
  • Subject has an acute bacterial endocarditis
  • Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke
  • Subject is receiving anticoagulants/antiplatelet agents
  • Subject has a body weight less than 40 kg
  • Major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods

Treatment and study plan

YM150

Drug

oral

Primary outcomes

  1. Composite assessment of VTE events and all cause death

    Time frame: Until day 28

Secondary outcomes

  1. Incidence of bleeding events

    Time frame: Until day 28

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Multi-center, Open Label Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2009
Registry last updated
Jun 16, 2010

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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