CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8,292 enrolled
Drug / intervention
edoxaban tosylate(DU-176b) +2 moredrug
Likely dose
edoxaban tosylate(DU-176b) 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00986154
NCT00986154Phase 3Completed
CompareCT.gov

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).

Daiichi Sankyo·interventional·Posted Sep 29, 2009·Updated Mar 5, 2019

In Brief

A Phase 3 clinical trial evaluating edoxaban tosylate(DU-176b), low molecular weight heparin/unfractionated heparin, and 1 other intervention for Venous Thromboembolism and 4 related conditions. Completed, enrolled 8,292 participants across 454 sites in 38 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Thromboembolism, Venous Thrombosis
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 29, 2009
Enrollment StartOct 1, 2009
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 16.8 years ago

Interventions

edoxaban tosylate(DU-176b)drug

edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment

low molecular weight heparin/unfractionated heparindrug

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

warfarindrug

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