drugset / Trial / NCT00700895

Assessing the Clinical Benefits of a Pharmacogenetics-Guided Dosing Regiment for Calculating Warfarin Maintenance Dose

NCT00700895 ↗

Phase 3 Unknown 320 enrolled National University Hospital, Singapore
RandomizedParallel-groupOpen-labelTreatment

Summary

Interethnic differences in warfarin dose requirements in the Asian population have been well described. Our previous studies showed that warfarin maintenance doses in our multi-ethnic population were closely related to patient demographics and genetic polymorphisms in cytochrome(CYP)P4502C9 and vitamin K epoxide reductase complex subunit 1(VKORC1). A retrospective regression model combining these predictors accounts for 57.8% of the variability in warfarin dose.

Timeline

Start
2006-08
Primary completion
2016-08
Completion
2017-08

Outcome

Met primary endpoint

paper fewer dose titrations during the first 2 weeks (1.77 vs. 2.93, difference -1.16, 90% CI -1.48 to -0.84, P < 0.001 for both non-inferiority and superiority). PMID 29986700 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Warfarin Small molecule — Oral

Indications

No indication recorded.