drugset / Trial / NCT05320627
Population Pharmacokinetics of Edoxaban in Chinese Patients With Non-Valvular Atrial Fibrillation
Phase 4
Completed
150 enrolled
China National Center for Cardiovascular Diseases
Chinese Academy of Medical Sciences, Fuwai Hospital · collab
NaSingle-groupOpen-labelOther
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.
Timeline
- Start
- 2022-03-30
- Primary completion
- 2024-08-30
- Completion
- 2024-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Edoxaban | Small molecule | 15 mg | Oral |
| Subject | Edoxaban | Small molecule | 30 mg | Oral |
| Subject | Edoxaban | Small molecule | 60 mg | Oral |