At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 502 enrolled

Drug / intervention

dabigatran with ASA +9 moredrug

Likely dose

Not stated in 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.

Search/NCT01227629

NCT01227629Phase 2Completed

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Dose Exploration in Patients With Atrial Fibrillation

Boehringer Ingelheim·interventional·Posted Oct 25, 2010·Updated May 5, 2014

In Brief

A Phase 2 clinical trial evaluating dabigatran with ASA, warfarin, and 1 other intervention for Atrial Fibrillation. Completed, enrolled 502 participants across 38 sites in 3 countries.

Detailed Summary

The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone or in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding and other adverse events. A secondary objective of this trial is to evaluate the anticoagulant effect of different doses of BIBR 1048, based on the reduction of plasma concentrations of D-dimer, a laboratory marker for activated coagulation in patients with atrial fibrillation (AF), and to correlate bleeding and other events with pharmacokinetic (PK) and pharmacodynamic (PD) data.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAtrial Fibrillation

CountriesDenmark, Sweden, United States

Collaborators--

Timeline

Phase 2CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2003

Primary CompletionNov 2004

First PostedOct 2010

TodayJul 2026

First PostedOct 25, 2010

Enrollment StartSep 1, 2003

Primary CompletionNov 1, 2004

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 15.7 years ago