Open Label, Non Randomized, Multiple Dose Phase I Study to Investigate the Elimination, Pharmacokinetics, Pharmacodynamics and Safety of Dabigatran Etexilate (Pradaxa) Under Steady State Conditions Before, During and After Haemodialysis in Patients With End Stage Renal Disease (ESRD) Undergoing Regular Haemodialysis.

Trial Profile

Open Label, Non Randomized, Multiple Dose Phase I Study to Investigate the Elimination, Pharmacokinetics, Pharmacodynamics and Safety of Dabigatran Etexilate (Pradaxa) Under Steady State Conditions Before, During and After Haemodialysis in Patients With End Stage Renal Disease (ESRD) Undergoing Regular Haemodialysis.

Completed
Phase of Trial: Phase I

Latest Information Update: 01 Mar 2015

At a glance

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

    • 01 Jun 2011 Status changed from not yet recruiting to completed as reported by ClinicalTrials.gov.
    • 22 Apr 2011 Planned End Date changed from 1 Apr 2011 to 1 May 2011.
    • 11 Mar 2011 Planned End Date changed from 1 Mar 2011 to 1 Apr 2011 as reported by ClinicalTrials.gov.
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