At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 174 enrolled
Drug / intervention
Dabigatran etexilate +2 moredrug
Likely dose
Dabigatran etexilate 110 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Dabigatran etexilate and Warfarin for Atrial Fibrillation. Completed, enrolled 174 participants across 28 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2005
Primary CompletionSep 2006
First PostedJun 2010
TodayJul 2026
First PostedJun 3, 2010
Enrollment StartNov 1, 2005
Primary CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.1 years ago
Interventions
Dabigatran etexilatedrug
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilatedrug
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Warfarindrug
Dose-adjusted warfarin based on target INR values