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).

Completed · Phase 3

Conditions studied: Venous Thromboembolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Thromboembolism, Venous Thrombosis

In brief

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.

Key facts

Study ID

NCT00986154

Run by

Daiichi Sankyo

People needed

8292

Starts

2009-10-01

Expected to finish

2013-04-01

Last updated by the study team

2019-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigational Site 7132 — Montgomery, Alabama, United States
• Investigational Site 7126 — Phoenix, Arizona, United States
• Investigational Site 7139 — Little Rock, Arkansas, United States
• Investigational Site 1070 — Anaheim, California, United States
• Investigational Site 7125 — Los Alamitos, California, United States
• Investigational Site 1093 — Monterey, California, United States
• Investigational Site 1069 — Palm Springs, California, United States
• Investigational Site 7150 — San Diego, California, United States
• Investigational Site 1089 — Vista, California, United States
• Investigational Site 1012 — Aurora, Colorado, United States
• Investigational Site 1013 — Boulder, Colorado, United States
• Investigational Site 1017 — Denver, Colorado, United States
• Investigational Site 1018 — Lakewood, Colorado, United States
• Investigational Site 1019 — Littleton, Colorado, United States
• Investigational Site 1022 — Thornton, Colorado, United States
• Investigational Site 1023 — Thornton, Colorado, United States
• Study site — Brandon, Florida, United States
• Investigational Site 1071 — Clearwater, Florida, United States
• Investigational Site 7117 — Fort Myers, Florida, United States
• Investigational Site 7106 — Gainesville, Florida, United States
• Investigational Site 1005 — Ocoee, Florida, United States
• Investigational Site 1006 — Orlando, Florida, United States
• Investigational Site 7144 — Sarasota, Florida, United States
• Investigational Site 7127 — St. Petersburg, Florida, United States
• Investigational Site 7103 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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