Clinical Trials Logo
  1. Home
  2. Deep Vein Thrombosis (DVT)
  3. NCT02798471

Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)

Pulmonary Embolism Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

The objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors) in the treatment and secondary prevention of VTE in pediatric subjects with regard to the composite efficacy endpoint (ie, symptomatic recurrent VTE, death as result of VTE, and no change or extension of thrombotic burden) during the first 3-month treatment period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02798471
Study type Interventional
Source Daiichi Sankyo, Inc.
Contact
Status Completed
Phase Phase 3
Start date March 27, 2017
Completion date May 24, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05050617 - Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism
Terminated NCT04558125 - Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism Phase 4
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Completed NCT03915925 - Short-term Clinical Deterioration After Acute Pulmonary Embolism
Completed NCT02502396 - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
Recruiting NCT05171075 - A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE Phase 3
Completed NCT04454554 - Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)
Completed NCT03173066 - Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography Phase 1
Terminated NCT03002467 - Impact Analysis of Prognostic Stratification for Pulmonary Embolism N/A
Completed NCT02334007 - Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery Phase 1/Phase 2
Completed NCT02611115 - Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography. N/A
Completed NCT01975090 - The SENTRY Clinical Study N/A
Not yet recruiting NCT01357941 - Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE) N/A
Completed NCT01326507 - Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism N/A
Completed NCT00773448 - Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism N/A
Completed NCT00780767 - Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism Phase 2
Completed NCT00720915 - D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months N/A
Completed NCT00771303 - Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
Completed NCT02476526 - Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease Phase 4
Completed NCT00244725 - Odiparcil For The Prevention Of Venous Thromboembolism Phase 2