A phase II trial randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsuled [150 or 220 mg once daily strating wiht half dose (i.e. 75 or 110 mg)on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 28-35 days, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.
- Conditions
- Prevention of venous thromboembolism following primary elective total hip replacement surgeryMedDRA version: 6.1Level: SOCClassification code 10005329
- Registration Number
- EUCTR2004-001988-21-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot 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