check_circleStudy Completed

Pulmonary embolism

Bayer Identifier:

15960

ClinicalTrials.gov Identifier:

NCT01516814

EudraCT Number:

Not Available

EU CT Number:

Not Available
Venous thromboembolism (VTE) treatment study in Japanese pulmonary embolism (PE) patients

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.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - Men and women >/= 20 years of age in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT)
  • - 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
February 2012 - November 2013
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Sapporo, 006-8555, Japan
Completed
Itabashi-ku, 173-8610, Japan
Completed
Meguro-ku, 152-8902, Japan
Completed
Yokohama, 245-8575, Japan
Terminated
Toyoake, 470-1192, Japan
Terminated
Osakasayama, 589-8511, 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
Terminated
Tsu, 514-8507, Japan
Terminated
Osaka, 530-8480, Japan
Completed
Kumamoto, 862-8505, Japan
Completed
Bunkyo-ku, 113-8519, Japan
Completed
Matsumoto, 390-8510, Japan
Completed
Suwa, 392-8510, Japan
Completed
Osaka, 553-0003, Japan
Completed
Saga, 840-8571, Japan
Completed
Kurume, 830-8543, Japan
Completed
Aomori, 030-8553, Japan
Terminated
Suita, 565-8565, Japan
Completed
Chiba, 260-8677, Japan
Completed
Shinagawa, 141-8625, Japan
Completed
Shimotsuke, 329-0498, Japan
Completed
Sakura, 285-8741, Japan
Completed
Chuoku, 104-8560, Japan
Completed
Shinjuku-ku, 162-8655, Japan
Completed
Shizuoka, 424-8636, Japan
Terminated
Nagoya, 457-8510, Japan
Completed
Osaka, 537-8511, 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
    enhanced_encryption
    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, 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

Additional Information

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