Trial Condition(s):

Deep Vein Thrombosis

Venous thromboembolism (VTE) treatment study in Japanese deep vein thrombosis (DVT) patients

Bayer Identifier:

14568

ClinicalTrials.gov Identifier:

NCT01516840

EudraCT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal
60
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Sapporo, Japan, 006-8555

Status
Completed
 
Locations

Investigative Site

Itabashi-ku, Japan, 173-8610

Status
Completed
 
Locations

Investigative Site

Meguro-ku, Japan, 152-8902

Status
Completed
 
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Investigative Site

Yokohama, Japan, 245-8575

Status
Completed
 
Locations

Investigative Site

Toyoake, Japan, 470-1192

Status
Completed
 
Locations

Investigative Site

Osakasayama, Japan, 589-8511

Status
Completed
 
Locations

Investigative Site

Otake, Japan, 739-0696

Status
Completed
 
Locations

Investigative Site

Maebashi, Japan, 371-8511

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
Locations

Investigative Site

Niigata, Japan, 951-8520

Status
Completed
 
Locations

Investigative Site

Kanazawa, Japan, 920-8650

Status
Completed
 
Locations

Investigative Site

Kahoku-gun, Japan, 920-0293

Status
Completed
 
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Investigative Site

Tsu, Japan, 514-8507

Status
Completed
 
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Investigative Site

Osaka, Japan, 530-8480

Status
Completed
 
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Investigative Site

Kumamoto, Japan, 862-8505

Status
Completed
 
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Investigative Site

Aomori, Japan, 030-8553

Status
Completed
 
Locations

Investigative Site

Suita, Japan, 565-8565

Status
Terminated
 
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Investigative Site

Shinagawa, Japan, 141-8625

Status
Terminated
 
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Investigative Site

Sakura, Japan, 285-8741

Status
Completed
 
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Investigative Site

Chuoku, Japan, 104-8560

Status
Completed
 
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Investigative Site

Shinjuku-ku, Japan, 162-8655

Status
Completed
 
Locations

Investigative Site

Shizuoka, Japan, 424-8636

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 537-8511

Status
Completed
 
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Investigative Site

Tokushima, Japan, 770-8503

Status
Completed
 
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Investigative Site

Wakayama, Japan, 640-8158

Status
Completed
 
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Investigative Site

Sasebo, Japan, 857-8511

Status
Completed
 
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Investigative Site

Fukuoka, Japan, 810-0001

Status
Completed
 
Locations

Investigative Site

Takarazuka, Japan, 665-0827

Status
Completed
 
Locations

Investigative Site

Okayama, Japan, 701-1192

Status
Completed
 

Trial Design