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

Venous Thromboembolism Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028950
• Other study ID #: 150-CL-044
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2009
• Last updated: June 14, 2010
• Start date: May 2009
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• YM150
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite assessment of VTE events and all cause death		Until day 28	No
Secondary	Incidence of bleeding events		Until day 28	Yes