Trial Condition(s):

Pulmonary Embolism

Venous thromboembolism (VTE) treatment study in Japanese pulmonary embolism (PE) patients

Bayer Identifier:

15960

ClinicalTrials.gov Identifier:

NCT01516814

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 rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT.

Inclusion Criteria
- Men and women >/= 20 years of age in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT)
Exclusion Criteria
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
 - 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 PE 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
40
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
Terminated
 
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
Terminated
 
Locations

Investigative Site

Osakasayama, Japan, 589-8511

Status
Terminated
 
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
 
Locations

Investigative Site

Tsu, Japan, 514-8507

Status
Terminated
 
Locations

Investigative Site

Osaka, Japan, 530-8480

Status
Terminated
 
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Investigative Site

Kumamoto, Japan, 862-8505

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8519

Status
Completed
 
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Investigative Site

Matsumoto, Japan, 390-8510

Status
Completed
 
Locations

Investigative Site

Suwa, Japan, 392-8510

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 553-0003

Status
Completed
 
Locations

Investigative Site

Saga, Japan, 840-8571

Status
Completed
 
Locations

Investigative Site

Kurume, Japan, 830-8543

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

Chiba, Japan, 260-8677

Status
Completed
 
Locations

Investigative Site

Shinagawa, Japan, 141-8625

Status
Completed
 
Locations

Investigative Site

Shimotsuke, Japan, 329-0498

Status
Completed
 
Locations

Investigative Site

Sakura, Japan, 285-8741

Status
Completed
 
Locations

Investigative Site

Chuoku, Japan, 104-8560

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 162-8655

Status
Completed
 
Locations

Investigative Site

Shizuoka, Japan, 424-8636

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 457-8510

Status
Terminated
 
Locations

Investigative Site

Osaka, Japan, 537-8511

Status
Completed
 

Trial Design