CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 290 enrolled
Drug / intervention
Edoxaban +1 moredrug
Likely dose
Edoxaban 15-30 mg tablets (ages 12-17 years) or 60 mg suspension (ages <12 years), dose-adjusted by age and weightAI-extracted
Key inclusion· 4
  • ✓Pediatric subjects from birth (≥38 weeks gestational age) to <18 years old
  • ✓Documented VTE (pulmonary embolism or deep vein thrombosis) confirmed by imaging and requiring ≥90 days anticoagulation
  • ✓At least 5 days of prior heparin therapy for the index VTE before randomization
  • ✓If initially on vitamin K antagonist, INR should be <2.0 before randomization
Key exclusion· 9
  • ✕Active bleeding or high risk of bleeding contraindicating anticoagulation
  • ✕Prior thrombolytic therapy, thrombectomy, or caval filter insertion for index VTE
  • ✕Concurrent use of rifampin
  • ✕Hepatic disease with coagulopathy: aPTT >50 seconds or INR >2.0 (not anticoagulation-related), ALT >5× ULN, or total bilirubin >2× ULN with direct >20%

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

Search/NCT02798471
NCT02798471Phase 3Completed
CompareCT.gov

A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)

Daiichi Sankyo·interventional·Posted Jun 14, 2016·Updated Feb 28, 2025

In Brief

A Phase 3 clinical trial evaluating Edoxaban and Standard of Care for Venous Thromboembolism (VTE) and 2 related conditions. Completed, enrolled 290 participants across 140 sites in 34 countries.

Detailed Summary

This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
CountriesArgentina, Brazil, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, El Salvador, France, Germany, Guatemala, Hungary, India, Israel, Kenya, Lebanon, Malaysia, Netherlands, Norway, Panama, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 14, 2016
Enrollment StartMar 27, 2017
Primary CompletionMay 24, 2022
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.0 years ago

Interventions

Edoxabandrug

15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age

Standard of Caredrug

Standard of care could include low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.