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.

Trial Profile

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.

Completed
Phase of Trial: Phase IV

Latest Information Update: 01 Aug 2016

At a glance

  • Drugs Dabigatran etexilate (Primary)
  • Indications Thrombosis
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 01 Apr 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 06 Mar 2013 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
    • 06 Mar 2013 Planned end date changed from 1 Jul 2013 to 1 Apr 2013 as reported by ClinicalTrials.gov.
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