Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).
Status: | Completed |
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Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | October 2009 |
End Date: | April 2013 |
A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing
recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the
legs and/or blood clots in the lungs.
recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the
legs and/or blood clots in the lungs.
Inclusion Criteria:
- Male or female subjects older than the minimum legal adult age (country specific);
- Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by
appropriate diagnostic imaging;
- Able to provide written informed consent
Exclusion Criteria:
- thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the
current episode of DVT and/or PE;
- More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
- Calculated Creatinine clearance (CrCL) < 30 mL/min;
- significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis)
or alanine transaminase (ALT) >\= 2 times the upper limit of normal (ULN), or total
bilirubin (TBL) x 1.5 times the ULN;
- patients with active cancer for whom long term treatment with (LMW) heparin is
anticipated;
- active bleeding or high risk for bleeding contraindicating treatment with (LMW)
heparin or warfarin;
- chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
- treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet
therapy;
- concurrent treatment with potent P-gp inhibitors;
- subjects with any condition that, as judged by the investigator, would place the
subject at increased risk of harm if he/she participated in the study
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