Trial Condition(s):
Pulmonary Embolism
Venous thromboembolism (VTE) treatment study in Japanese pulmonary embolism (PE) patients
Bayer Identifier:
15960
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Sapporo, Japan, 006-8555 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Itabashi-ku, Japan, 173-8610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Meguro-ku, Japan, 152-8902 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 245-8575 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toyoake, Japan, 470-1192 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osakasayama, Japan, 589-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Maebashi, Japan, 371-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Niigata, Japan, 951-8520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kanazawa, Japan, 920-8650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kahoku-gun, Japan, 920-0293 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tsu, Japan, 514-8507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 530-8480 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kumamoto, Japan, 862-8505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8519 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsumoto, Japan, 390-8510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suwa, Japan, 392-8510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 553-0003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saga, Japan, 840-8571 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kurume, Japan, 830-8543 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aomori, Japan, 030-8553 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suita, Japan, 565-8565 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chiba, Japan, 260-8677 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinagawa, Japan, 141-8625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shimotsuke, Japan, 329-0498 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sakura, Japan, 285-8741 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chuoku, Japan, 104-8560 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 162-8655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shizuoka, Japan, 424-8636 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 457-8510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 537-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Randomized, open-label, parallel-group, active-controlled study of rivaroxaban in patients with acute symptomatic pulmonary embolism, with or without symptomatic deep vein thrombosis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Number of participants with newly onset of symptomatic venous thromboembolism (VTE)Timeframe: Up to 12 months
- Number of clinically relevant bleedingsTimeframe: Up to 2 days after last dose
Secondary Outcome
- Number of participants with improvement in thrombotic burdenTimeframe: At week 3
- Number of participants with deterioration in thrombotic burdenTimeframe: Up to 12 months
- Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombusTimeframe: Up to 12 months
Additional Information
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