Status:
COMPLETED
Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Scientific Affairs, LLC
Conditions:
Deep Vein Thrombosis
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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) ...
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...
Eligibility Criteria
Inclusion
- Men and women \>/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE)
Exclusion
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
- More than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of DVT to randomization
- Calculated creatinine clearance (CLCR) \< 30 mL/min
- Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- Active bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin
- Systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01516840
Start Date
March 1 2012
End Date
January 1 2014
Last Update
January 18 2017
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
Toyoake, Aichi-ken, Japan, 470-1192
2
Aomori, Aomori, Japan, 030-8553
3
Sakura, Chiba, Japan, 285-8741
4
Fukuoka, Fukuoka, Japan, 810-0001