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Therapeutic Areas: Cardiology/Vascular Diseases | Hematology
Disease Category: Venous Thromboembolism
Location: United States, WA
Clinical Trial Details
Research Study Summary
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.
Patient 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
Patient Exclusion Criteria:
- Age 18 years and older.
- 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 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
To Learn more
Both Male and Female
Date Last Changed:
July 16, 2013
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