Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate

Arthroplasty, Replacement Clinical Trial

Official 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Arthroplasty, Replacement
Moderate Renal Impairment (CrCl 30-50 mL/Min)
Prevention of Venous Thromboembolism
Renal Insufficiency
Thromboembolism
Venous Thromboembolism

Clinical Trial Details

NCT number	NCT01184989
Study type	Interventional
Source	Boehringer Ingelheim
Contact
Status	Completed
Phase	Phase 4
Start date	August 2010
Completion date	April 2013

View Details

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