check_circleStudy Completed

Deep vein thrombosis

Bayer Identifier:

14568

ClinicalTrials.gov Identifier:

NCT01516840

EudraCT Number:

Not Available

EU CT Number:

Not Available
Venous thromboembolism (VTE) treatment study in Japanese deep vein thrombosis (DVT) patients

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - Men and women >/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE)
  • - 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

Trial summary

Enrollment Goal
60
Trial Dates
March 2012 - January 2014
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sapporo, 006-8555, Japan
Completed
Itabashi-ku, 173-8610, Japan
Completed
Meguro-ku, 152-8902, Japan
Completed
Yokohama, 245-8575, Japan
Completed
Toyoake, 470-1192, Japan
Completed
Osakasayama, 589-8511, Japan
Completed
Otake, 739-0696, Japan
Completed
Maebashi, 371-8511, Japan
Completed
Bunkyo-ku, 113-8655, Japan
Completed
Niigata, 951-8520, Japan
Completed
Kanazawa, 920-8650, Japan
Completed
Kahoku-gun, 920-0293, Japan
Completed
Tsu, 514-8507, Japan
Completed
Osaka, 530-8480, Japan
Completed
Kumamoto, 862-8505, Japan
Completed
Aomori, 030-8553, Japan
Terminated
Suita, 565-8565, Japan
Terminated
Shinagawa, 141-8625, Japan
Completed
Sakura, 285-8741, Japan
Completed
Chuoku, 104-8560, Japan
Completed
Shinjuku-ku, 162-8655, Japan
Completed
Shizuoka, 424-8636, Japan
Completed
Osaka, 537-8511, Japan
Completed
Tokushima, 770-8503, Japan
Completed
Wakayama, 640-8158, Japan
Completed
Sasebo, 857-8511, Japan
Completed
Fukuoka, 810-0001, Japan
Completed
Takarazuka, 665-0827, Japan
Completed
Okayama, 701-1192, Japan

Primary Outcome

  • Number of participants with newly onset of symptomatic venous thromboembolism (VTE)
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of clinically relevant bleedings
    date_rangeTime Frame:
    Up to 2 days after last dose
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    Safety Issue:
    Yes

Secondary Outcome

  • Number of participants with improvement in thrombotic burden
    date_rangeTime Frame:
    At week 3
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with deterioration in thrombotic burden
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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