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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01184989

First received: August 16, 2010

Last updated: June 12, 2013

Last verified: June 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 16, 2010

Last Updated Date

June 12, 2013

Start Date ^ICMJE

August 2010

Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacodynamic parameters: Clotting time and calculated dabigatran plasma concentration (using Hemoclot® Direct Thrombin Inhibitor Assay) [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]
Pharmacokinetic parameters: - total dabigatran plasma concentrations in serial samples [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01184989 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open Label, Non-comparative, Pharmacokinetic and Pharmacodynamic Study to Evaluate the Effect of Pradaxa (Dabigatran Etexilate) on Coagulation Parameters Including a Calibrated Thrombin Time Test in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Knee Replacement Surgery

Brief Summary

In order 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 knee-replacement surgery this PK/PD study will be conducted.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Arthroplasty, Replacement, Knee
Venous Thromboembolism

Intervention ^ICMJE

Drug: Dabigatran etexilate

once daily approved dose by EMEA and Health Canada

Study Arm (s)

Dabigatran etexilate

open label, once daily dose approved by EMEA and Health Canada

Intervention: Drug: Dabigatran etexilate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

116

Completion Date

April 2013

Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Patients scheduled for primary unilateral elective total knee or hip replacement, male or female being 18 years or older with moderate renal impairment (creatinine clearance 30-50 ml/min)

Exclusion criteria:

Patients requiring chronic treatment with anticoagulants (e.g. vitamin K antagonists; e.g. patients with atrial fibrillation, patients with artificial heart valves, etc.).
Patients weighing less than 40 kg.
Treatment with anticoagulants, clopidogrel, ticlopidine, abciximab, aspirin >162.5 mg/day or NSAID with t 1/2 >12 hours within 7 days prior to hip or knee replacement surgery OR anticipated need while the patient is receiving study medication and prior to 24 hours after the last administration of study medication (COX-2 selective inhibitors are allowed) because of anticipated need other restricted medication during the treatment period.
Ongoing treatment for VTE.
Liver disease expected to have any potential impact on survival (ie, hepatitis B or C, cirrhosis) or ALT/AST >3 x ULN. This does not include Gilbert¿s syndrome or hepatitis A with complete recovery.
Known severe renal insufficiency (CrCl <30 ml/min) and patients with mild renal insufficiency (CrCl >50 ml/min) or normal renal function.
History of thrombocytopenia, including heparin-induced thrombocytopenia, or a platelet count <100,000 cells/microliter at randomisation

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Canada, Czech Republic, Finland, Netherlands, Sweden

Administrative Information

NCT Number ^ICMJE

NCT01184989

Other Study ID Numbers ^ICMJE

1160.86, 2010-018723-26

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim Pharmaceuticals

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

June 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top