NCT01516840

Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients

Randomized, Open-label (Double Blind Among Rivaroxaban Groups in the Initial 3 Weeks), Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis Without Symptomatic Pulmonary Embolism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.

Detailed description

The general design of the trial is open label between the Rivaroxaban and the reference arm. However, there are two groups in the Rivaroxaban arm only for the initial 3 weeks. Between these two groups and in this initial period, the study is blinded.

Conditions

• Deep Vein Thrombosis

Interventions

Type	Name	Description
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	10 mg twice daily for 21 days, followed by 15 mg once daily
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	15 mg twice daily for 21 days, followed by 15 mg once daily
DRUG	Unfractionated heparin	To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
DRUG	Warfarin	To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2012-01-25
• Last updated: 2017-01-18

Locations

29 sites across 1 country: Japan