MedTrace Logo

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

NCT01184989 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2018-09-25

Study results available
· View outcomes & findings →

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.

Conditions

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

Interventions

DRUG

Dabigatran etexilate

once daily approved dose by EMEA and Health Canada

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Austria
  • Canada
  • Czechia
  • Finland
  • Netherlands
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01184989 on ClinicalTrials.gov