Protocol for Phase IIb Study of YM150. A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery.
- Conditions
- I829T149-T149 Injury, unspecified-I829 Embolism and thrombosis of unspecified veinEmbolism and thrombosis of unspecified veinInjury, unspecified
- Registration Number
- PER-071-09
- Lead Sponsor
- Astellas Pharma Europe B.V,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Written informed consent [and the Authorization of the Health Insurance Responsibility and Transferability Act (HIPPA) only for centers in the United States of America] were obtained before making the selection.
• Man or woman 18 years of age or older.
• Elective hip replacement surgery is planned for the subject.
• 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.)
• Female subject who is pregnant or lactating, or has a positive pregnancy test within 72 hours prior to randomization.
• Subject has active bleeding or any condition associated with increased risk of bleeding including known hemorrhagic disorder or thrombocytopenia (platelet count <100,000/mm3) at screening.
• Subject has had an MI or stroke within 3 months before planned hip replacement surgery.
• Subject has persistent blood pressure (BP) of 160 mmHg systolic or higher and/or 100 mmHg diastolic or higher at baseline with or without medication.
• Subject has any concurrent illness, which, in the opinion of the investigator, may interfere with treatment or evaluation of safety or completion of this study.
• Subject has had major trauma or major surgery; or eye, spinal cord or brain surgery within 3 months before planned hip replacement surgery.
• Subject requires scheduled major surgery or other invasive procedures with potential for uncontrolled bleeding during the study.
• Subject requires use of prohibited concomitant medication (e.g. anticoagulants such as heparins, thrombin inhibitors, coumarins, or acetylsalicylic acid use of >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.
• Subject has hypersensitivity or any contraindications to iodinated contrast medium or enoxaparin.
• Subject has planned indwelling intrathecal or epidural catheter for more than 6 hours after the end of surgery.
• Subject has a creatinine clearance of <60 mL/min, as calculated by the Cockcroft-Gault equation (see Appendix 1) at screening.
• Subject has hepatic insufficiency or presents with AST or ALT > 2 times or total bilirubin > 1.5 times ULN at screening.
• Subject has a lower extremity amputation (toe(s) amputation only is acceptable).
• Subject is scheduled for simultaneous bilateral hip replacement surgery.
• 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.
• Subject has previously participated in a clinical trial with YM150.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method