Clinical Trials Directory

Trials / Completed

CompletedNCT02073682

Cancer Venous Thromboembolism (VTE)

A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
1,046 (actual)
Sponsor
Daiichi Sankyo · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.

Conditions

Interventions

TypeNameDescription
DRUGEdoxabanAfter the 5 day treatment with LMWH, patients receive edoxaban 60 mg once daily (QD) as 2 × 30 mg tablets (or 1 x 30 mg tablet QD for patients requiring dose adjustment) for the remainder of the treatment period.
DRUGDalteparinDalteparin was administered via subcutaneous injection at a dose of 200 IU/kg (maximum daily dose 18,000 IU) for 30 days, and at a dose of 150 IU/kg from Day 31 to the end of treatment.
DRUGLow molecular weight heparinTherapeutic doses of subcutaneous LMWH were administered for at least 5 days (to patients in the edoxaban group); this 5-day period may have included the pre-randomization LMWH (if applicable). The choice of parenteral LMWH was up to the treating physician.

Timeline

Start date
2015-07-16
Primary completion
2017-09-15
Completion
2017-09-15
First posted
2014-02-27
Last updated
2019-03-06
Results posted
2018-10-24

Locations

9 sites across 6 countries: United States, Belgium, France, Hungary, Italy, Netherlands

Source: ClinicalTrials.gov record NCT02073682. Inclusion in this directory is not an endorsement.