Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

Summary

To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran exposure (in Part II)

Timeline

Start

2012-11

Primary completion

2013-06

Completion

2013-06

Outcome

Missed primary endpoint

registry p = 0.9456; geometric Mean Ratio 149.38 (90% CI 124.388 to 179.383); ANOVA; note: p-value for ratio outside interval 80% - 125% NCT01734772 ↗

registry p = 0.9841; geometric Mean Ratio 164.74 (90% CI 133.945 to 202.619); ANOVA; note: p-value for ratio outside interval 80% - 125% NCT01734772 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dabigatran etexilate	Unknown	—	—
Subject	Ticagrelor	Small molecule	—	—

Indications

No indication recorded.