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

CW ID: 183319
Date Last Changed: July 16, 2013

Clinical Trial Snapshot

Both Male and Female
Overall Status
Facility Type


Christine Goetz, BA; CCRC
MultiCare Health System
314 Martin Luther King, Jr. Way, Suite 402
Tacoma, WA 98405
Phone: 253-403-7193

View Map

Research Center Information:

MultiCare Health System

Volunteer for this Trial

If you would like to learn more about participating in this research study, please email the trial contact using the form below. We value your privacy and your information will only be used by the research center to contact you regarding this study.

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.