Clinical Trial: Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein
Brief Summary: The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome:
- Number of participants with newly onset of symptomatic venous thromboembolism (VTE) [ Time Frame: Up to 12 months ]
- Number of clinically relevant bleedings [ Time Frame: Up to 2 days after last dose ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of participants with improvement in thrombotic burden [ Time Frame: At week 3 ]
- Number of participants with deterioration in thrombotic burden [ Time Frame: Up to 12 months ]
- Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus [ Time Frame: Up to 12 months ]
Original Secondary Outcome: Same as current
Information By: Bayer
Dates:
Date Received: January 20, 2012
Date Started: February 2012
Date Completion:
Last Updated: January 19, 2017
Last Verified: January 2017
