Deep Vein Thrombosis Clinical Trial
Official title:
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
Verified date | January 2017 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Men and women >/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer | Janssen Scientific Affairs, LLC |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with newly onset of symptomatic venous thromboembolism (VTE) | Up to 12 months | ||
Primary | Number of clinically relevant bleedings | Up to 2 days after last dose | ||
Secondary | Number of participants with improvement in thrombotic burden | At week 3 | ||
Secondary | Number of participants with deterioration in thrombotic burden | Up to 12 months | ||
Secondary | Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus | Up to 12 months |
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