drugset / Trial / NCT01136408
A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin
RandomizedParallel-groupOpen-labelPrevention
Summary
The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with warfarin.
Timeline
- Start
- 2005-11
- Primary completion
- 2006-09
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabigatran etexilate | Unknown | 110 mg | Oral |
| Subject | Dabigatran etexilate | Unknown | 150 mg | Oral |
| Comparator | Warfarin | Small molecule | — | — |