Open Label, Randomised Exploratory Dose Response Study in Pharmacodynamics and Safety of BIBR 1048 (110 mg Twice Daily (b.i.d.) and 150 mg b.i.d.) for 12 Weeks in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin

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.

本研究的核心目标为，以华法林（warfarin）为对照，评估针对阵发性、持续性或永久性非瓣膜性心房颤动（non-valvular atrial fibrillation）患者，口服给予110mg及150mg剂量、每日两次的达比加群酯（dabigatran etexilate, BIBR 1048）连续给药12周的安全性。