Trials / Completed
CompletedNCT02798471
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 290 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 1 Day – 17 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Edoxaban | 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 |
| DRUG | Standard of Care | Standard of care could include low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors. |
Timeline
- Start date
- 2017-03-27
- Primary completion
- 2022-05-24
- Completion
- 2022-05-24
- First posted
- 2016-06-14
- Last updated
- 2025-02-28
- Results posted
- 2023-03-06
Locations
140 sites across 34 countries: United States, Argentina, 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02798471. Inclusion in this directory is not an endorsement.