Pradaxa (Dabigatran Etexilate) VTE Prevention After Elective Total Hip or Knee Replacement Surgery
Terminated
Boehringer Ingelheim
2010-08-01
an open, prospective, observational study to collect data on safety (major bleeding events)
and efficacy (symptomatic venous thromboembolism(VTE)) of a switch from Enoxaparin to
dabigatran etexilate in patients with total knee replacement (TKR) and total hip replacement
(THR)
Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate
Completed
Boehringer Ingelheim
Phase 4
2010-08-01
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 in Healthy Volunteers of the Reversion by Haemostatic Drugs of the Anticoagulant Effect of New Anti-thrombotics
Completed
University Hospital, Grenoble
Phase 4
2010-11-01
The purpose of this study is to evaluate whether the effect of the two new anticoagulants,
Dabigatran and Rivaroxaban, can be reversed by non-specific and specific inhibitors. For
Dabigatran the investigators will test the non-specific inhibitors: prothrombin complex
concentrate (PCC), recombinant activated coagulation factor VII, and activated
prothrombin-complex (FEIBA). For Rivaroxaban the investigators will test a specific
Rivaroxaban decoy (FXa-GLAless). This will be done in a laboratory using blood plasma from
healthy male volunteers.
Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis
Completed
Boehringer Ingelheim
Phase 1
2010-11-01
The current study will allow the assessment of pharmacokinetics, pharmacodynamics,
elimination rate and clearance of dabigatran etexilate during and following haemodialysis in
ESRD patients.
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