A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 8 +- 2 days, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery
Active, not recruiting
- Conditions
- Prevention of venous thromboembolism following primary elective total knee replacement surgery
- Registration Number
- EUCTR2004-001317-34-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of dabigatran etexilate in preventing venous thromboembolism post total knee replacement?
How does the efficacy of dabigatran compare to enoxaparin in VTE prevention for elective knee surgery patients?
Which biomarkers are associated with response to direct thrombin inhibitors like dabigatran in orthopedic surgery?
What are the adverse event profiles of dabigatran versus enoxaparin in postoperative VTE prevention?
How do dabigatran's pharmacokinetics influence dosing strategies in orthopedic thromboprophylaxis compared to LMWHs?