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
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Calcium heparin; Dalteparin; Edoxaban; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Warfarin

Criteria

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