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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937820
• Other study ID #: 150-CL-104
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2009
• Last updated: January 5, 2011
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, 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	Joint incidence of deep vein thromboembolism or pulmonary thromboembolism		52 weeks	No
Secondary	Incidence of each thromboembolism		52 weeks	No
Secondary	All cause mortality		52 weeks	Yes
Secondary	Incidence of bleeding event		52 weeks	Yes