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Population Pharmacokinetics of Edoxaban in Chinese Patients With Non-Valvular Atrial Fibrillation

NCT05320627 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-23

No results posted yet for this study

Summary

Based on the population pharmacokinetic data of Chinese patients with atrial fibrillation, the study will evaluate the suitability of the ENGAGE Population Pharmacokinetics model of edoxaban in patients with atrial fibrillation in China, and build a predictive dose model of edoxaban that meets the characteristics of Chinese people. It can provide perfect individualized dosing plan improves clinical efficacy and reduces adverse drug reactions.

Conditions

  • Non-Valvular Atrial Fibrillation

Interventions

DRUG

Edoxaban

Eligible patients will receive Edoxaban tablet once a day for 12 weeks

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Principal Investigators

  • Lu Hua, 1 · Chinese Academy of Medical Sciences, Fuwai Hospital

  • Lei Tian, 2 · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2024-08-30
Completion
2024-10-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05320627 on ClinicalTrials.gov