Status:
COMPLETED
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).
Lead Sponsor:
Daiichi Sankyo
Conditions:
Venous Thromboembolism
Deep Vein Thrombosis (DVT)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
8292 Patients enrolled
Trial Details
Trial ID
NCT00986154
Start Date
October 1 2009
End Date
April 1 2013
Last Update
March 5 2019
Active Locations (454)
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1
Investigational Site 7103
Mobile, Alabama, United States, 36608
2
Investigational Site 7132
Montgomery, Alabama, United States, 36116
3
Investigational Site 7126
Phoenix, Arizona, United States, 85006
4
Investigational Site 7139
Little Rock, Arkansas, United States, 72205