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Clinical trial

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

NCT01184989 is registered in ClinicalTrials.gov with Boehringer Ingelheim as lead sponsor.

NCT NCT01184989
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Boehringer Ingelheim
Phase
Phase 4
Overall status
Completed
Start date
August 31, 2010
Completion date
April 30, 2013
Enrollment
142 (actual)
Sites
10

Conditions

As the registry lists them; a condition with its own page is linked.

arthroplasty, replacement, moderate renal impairment (crcl 30-50 ml/min), prevention of venous thromboembolism