AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: Bristol-Myers Squibb
• Treatments: Apixaban; Calcium heparin; Heparin; Warfarin

Criteria

Inclusion Criteria:

• Acute symptomatic proximal DVT with evidence of proximal thrombosis

• Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches

Exclusion Criteria:

• Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA.

• Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg

• Subjects requiring dual anti-platelet therapy