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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01516840
Other study ID # 14568
Secondary ID
Status Completed
Phase Phase 3
First received January 20, 2012
Last updated January 17, 2017
Start date March 2012
Est. completion date January 2014

Study information

Verified date January 2017
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Bayer Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

Japan, 

Outcome

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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