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.
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.
| Condition | Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT) |
|---|---|
| Treatment | Standard of Care, Edoxaban |
| Clinical Study Identifier | NCT02798471 |
| Sponsor | Daiichi Sankyo, Inc. |
| Last Modified on | 28 May 2022 |
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