REgulation of Coagulation in ORthopedic Surgery to prevent DVT and PE, controlled, double-blind, randomized study of BAY 59-7939 in the extended prevention of VTE in patients undergoing elective total hip replacement - RECORD 1
- Conditions
- Prevention of VTE in patients undergoing elective total hip replacementMedDRA version: 6.1Level: HLGTClassification code 10014523
- Registration Number
- EUCTR2005-004351-35-IT
- Lead Sponsor
- BAYER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4200
1.Male and female patients aged 18 years or above. 2.Patients scheduled for elective total hip replacement. 3.Patients written informed consent for participation after receiving detailed written and oral previous information to any study specific procedures.
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
1.Planned, staged total bilateral hip replacement; 2.Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin; 3.Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin; 4.Conditions prohibiting bilateral venography amputation of one leg, allergy to contrast media ; 5.Pregnant and breast-feeding women; 6.Women with child-bearing potential not using adequate birth control method. Note as adequate method of birth control oral contraception is recommended. If oral contraception is not feasible both partners should use adequate barrier birth control ; 6.Drug- or alcohol abuse; 7.Concomitant use of HIV-protease inhibitors; 8.Therapy with another investigational product within 30 days prior start of study; 9.Planned intermittent pneumatic compression during active treatment period; 10.Concomitant participation in another trial or study; 11.Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the investigator see section 4.5.7 12.For other concomitant medication not allowed see section 4.5.7.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this trial is to assess the efficacy and safety of BAY 59-7939 10 mg once daily dosing in extended prevention of VTE in men and women aged 18 years or above undergoing elective total hip replacement.;Secondary Objective: ;Primary end point(s): Any DVT proximal and/or distal and Non fatal PE and Death from all causes.
- Secondary Outcome Measures
Name Time Method