Trials / Completed
CompletedNCT01184989
Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate
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
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 142 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Dabigatran etexilate | once daily approved dose by EMEA and Health Canada |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2010-08-19
- Last updated
- 2018-09-25
- Results posted
- 2014-05-23
Locations
10 sites across 6 countries: Austria, Canada, Czechia, Finland, Netherlands, Sweden
Source: ClinicalTrials.gov record NCT01184989. Inclusion in this directory is not an endorsement.