Trials / Completed
CompletedNCT00986154
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).
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).
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 8,292 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Venous Thromboembolism
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism (PE)
- Thromboembolism
- Venous Thrombosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | edoxaban tosylate(DU-176b) | edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment |
| DRUG | low molecular weight heparin/unfractionated heparin | LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily. Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment |
| DRUG | warfarin | tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2009-09-29
- Last updated
- 2019-03-05
- Results posted
- 2015-02-25
Locations
454 sites across 38 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00986154. Inclusion in this directory is not an endorsement.