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Therapeutic Areas: Cardiology/Vascular Diseases | Hematology
Disease Category: Venous Thromboembolism
Location: United States, WA

Clinical Trial Details

Overview

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).

Purpose

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
Phase

3

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

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

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Research Center Information: MultiCare Health System

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183319

Date Last Changed: July 16, 2013


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