At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 142 enrolled
Drug / intervention
Dabigatran etexilatedrug
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.
An Open Label, Non-comparative, Pharmacokinetic and Pharmacodynamic Study to Evaluate the Effect of Dabigatran Etexilate on Coagulation Parameters Including a Calibrated Thrombin Time Test in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Primary Unilateral Elective Total Knee or Hip Replacement Surgery
In Brief
A Phase 4 clinical trial evaluating Dabigatran etexilate for Arthroplasty, Replacement and 2 related conditions. Completed, enrolled 142 participants across 10 sites in 6 countries.
Detailed Summary
To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with moderate renal impairment undergoing elective total hip- or knee-replacement surgery, this PK/PD study will be conducted.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthroplasty, Replacement, Prevention of Venous Thromboembolism, Moderate Renal Impairment (CrCl 30-50 mL/Min)
CountriesAustria, Canada, Czechia, Finland, Netherlands, Sweden
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
First PostedAug 2010
Primary CompletionApr 2013
TodayJul 2026
First PostedAug 19, 2010
Enrollment StartAug 1, 2010
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.9 years ago
Interventions
Dabigatran etexilatedrug
once daily approved dose by EMEA and Health Canada