drugset / Trial / NCT00808067

RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

NCT00808067 ↗

Phase 3 Completed 5897 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

The purposes of this study are: 1. To evaluate the long-term safety of dabigatran etexilate 2. To assess the effect of a knowledge translation intervention on patient outcomes

Timeline

Start
2008-11
Primary completion
2012-12
Completion
2012-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Dabigatran 110 mg vs Dabigatran 150 mg; p = 0.0055; Hazard Ratio (HR) 0.77 (95% CI 0.64 to 0.93); Regression, Cox NCT00808067 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran Unknown 110 mg —
Subject Dabigatran Unknown 150 mg —

Indications