drugset / Trial / NCT02964949

Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

NCT02964949

Completed 607 enrolled Daiichi Sankyo Quintiles, Inc. · collab
RandomizedParallel-groupTriple-blindBasic science

Summary

Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart. This can lead to blood clots forming in the heart chamber. Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for up to 12 months, with a 2-4 week follow-up, after which their participation is complete. Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30, 90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).

Timeline

Start
2017-01-24
Primary completion
2018-10-09
Completion
2018-10-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Edoxaban Small molecule 60 mg Oral
Subject Edoxaban Small molecule 75 mg Oral

Indications