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OpenTrials
Completed

NCT Number: NCT00937820

Prevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous Thromboembolism

The study objective is to evaluate the efficacy and safety of oral YM150 for 52 weeks in patients with a history of venous thromboembolism.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chugoku, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject has symptomatic VTE and/or asymptomatic deep vein thrombosis
  • Written informed consent obtained before screening

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 the screening visit
  • 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

Treatment and study plan

YM150

Drug

oral

Primary outcomes

  1. Joint incidence of deep vein thromboembolism or pulmonary thromboembolism

    Time frame: 52 weeks

Secondary outcomes

  1. Incidence of each thromboembolism

    Time frame: 52 weeks

  2. All cause mortality

    Time frame: 52 weeks

  3. Incidence of bleeding event

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

YM150 Long Term Study - Long-term Study in Patients With a History of Venous Thromboembolism

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 13, 2009
Registry last updated
Jan 6, 2011

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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