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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01516840
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : January 18, 2017
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):

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) 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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Unfractionated heparin Drug: Warfarin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1 Drug: Rivaroxaban (Xarelto, BAY59-7939)
10 mg twice daily for 21 days, followed by 15 mg once daily

Experimental: Arm 2 Drug: Rivaroxaban (Xarelto, BAY59-7939)
15 mg twice daily for 21 days, followed by 15 mg once daily

Active Comparator: Arm 3 Drug: Unfractionated heparin
To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)

Active Comparator: Arm 4 Drug: Warfarin
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)

Primary Outcome Measures :
  1. Number of participants with newly onset of symptomatic venous thromboembolism (VTE) [ Time Frame: Up to 12 months ]
  2. Number of clinically relevant bleedings [ Time Frame: Up to 2 days after last dose ]

Secondary Outcome Measures :
  1. Number of participants with improvement in thrombotic burden [ Time Frame: At week 3 ]
  2. Number of participants with deterioration in thrombotic burden [ Time Frame: Up to 12 months ]
  3. Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus [ Time Frame: Up to 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01516840

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Toyoake, Aichi, Japan, 470-1192
Sakura, Chiba, Japan, 285-8741
Maebashi, Gunma, Japan, 371-8511
Otake, Hiroshima, Japan, 739-0696
Sapporo, Hokkaido, Japan, 006-8555
Takarazuka, Hyogo, Japan, 665-0827
Kahoku-gun, Ishikawa, Japan, 920-0293
Kanazawa, Ishikawa, Japan, 920-8650
Yokohama, Kanagawa, Japan, 245-8575
Tsu, Mie, Japan, 514-8507
Sasebo, Nagasaki, Japan, 857-8511
Osakasayama, Osaka, Japan, 589-8511
Suita, Osaka, Japan, 565-8565
Bunkyo-ku, Tokyo, Japan, 113-8655
Chuoku, Tokyo, Japan, 104-8560
Itabashi-ku, Tokyo, Japan, 173-8610
Meguro-ku, Tokyo, Japan, 152-8902
Shinagawa, Tokyo, Japan, 141-8625
Shinjuku-ku, Tokyo, Japan, 162-8655
Aomori, Japan, 030-8553
Fukuoka, Japan, 810-0001
Kumamoto, Japan, 862-8505
Niigata, Japan, 951-8520
Okayama, Japan, 701-1192
Osaka, Japan, 530-8480
Osaka, Japan, 537-8511
Shizuoka, Japan, 424-8636
Tokushima, Japan, 770-8503
Wakayama, Japan, 640-8158
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
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Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT01516840     History of Changes
Other Study ID Numbers: 14568
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Keywords provided by Bayer:
acute symptomatic deep vein thrombosis
Additional relevant MeSH terms:
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Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors