Prevention of venous thromboembolism after hip replacement surgery. MedDRA version: 9.1 Level: LLT Classification code 10043634 Term: Thrombosis prophylaxis
Conditions
Interventions
Product Name: YM150
Product Code: YM150
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: YM150
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Phar
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is eligible for the study if all of the following apply: 1. Written informed consent [and Healthcare Insurance Portability and Accountability Act (HIPAA) Authorization for U.S. sites only] has been obtained before screening. 2. Male or female subject aged 18 years or older. 3. Subject is scheduled for elective hip replacement surgery. 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
Exclusion criteria: Subject will be excluded from participation if any of the following applies: 1. Female subject of childbearing potential who refuses to use a medically acceptable form of contraception throughout the study. (Acceptable methods of contraception are: oral or injectable hormonal contraceptives, intrauterine devices, vaginal hormonal rings, and only in combination with a male condom a vaginal diaphragm or cervical caps. Male study subjects should be advised to use male condom in addition to having their partner use another acceptable method during the study and for three months after the last dose.) 2. Female subject who is pregnant or lactating, or has a positive pregnancy test within 72 hours prior to randomization. 3. Subject has active bleeding or any condition associated with increased risk of bleeding including known hemorrhagic disorder or thrombocytopenia (platelet count 163 mg/day) at any time during the period extending from one week before the start of study drug until the end of the treatment period of 35 days. 10. Subject has hypersensitivity or any contraindications to iodinated contrast medium or enoxaparin. 11. Subject has planned indwelling intrathecal or epidural catheter for more than 6 hours after the end of surgery. 12. Subject has a creatinine clearance of 2 times or total bilirubin > 1.5 times ULN at screening. 14. Subject has a lower extremity amputation (toe(s) amputation only is acceptable). 15. Subject is scheduled for simultaneous bilateral hip replacement surgery. 16. Subject has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing of informed consent for the present study. 17. Subject has previously participated in a clinical trial with YM150.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy and safety of 15 mg bid, 30 mg qd, 30 mg bid and 60 mg qd YM150 and to compare efficacy and safety with enoxaparin 40 mg qd, in subjects undergoing elective hip replacement surgery.;Secondary Objective: *To characterize PK of the active metabolite YM-222714, in subjects undergoing elective hip replacement surgery. *To characterize PK/Coagulation parameters relationship, in subjects undergoing elective hip replacement surgery. *To evaluate the effects of YM150 and enoxaparin on: - The health status of subjects undergoing elective hip replacement surgery, - The health care resource use associated with both treatment options, and - The cost-effectiveness associated with both treatment options. ;Primary end point(s): The primary efficacy variable is the composite of the following adjudicated events observed until day 12: • Proximal or distal DVT • Symptomatic DVT (proximal and distal) • Non-fatal PE • Death from all causes | — |
Countries
Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed