Prophylaxis of venous thromboembolism MedDRA version: 7.1 Level: LLT Classification code 10049909
Conditions
Interventions
Product Name: DU-176b
Product Code: DU-176b
Pharmaceutical Form: Coated tablet
Product Name: DU-176b
Product Code: DU-176b
Pharmaceutical Form: Coated tablet
Sponsors
Daiichi Medical Research Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 18 years of age or greater scheduled for elective unilateral total hip replacement surgery (including revisions). 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: Preoperative Exclusion Criteria: Patients that meet any of the following criteria will not be included in the study: 1. Patients previously enrolled in a DU-176b study; 2. Patients less than 18 years of age; 3. Patients with known or suspected hereditary or acquired bleeding or coagulation disorder and increased risk of thromboembolic events; 4. Patients with an increased risk of bleeding; 1. Hemorrhagic stroke, or conditions predisposing to intracranial hemorrhage (e.g., previous intracranial or intra-ocular hemorrhage or non-hemorrhagic stroke within the past three months; intracranial malignancy) 2. Systemic bleeding, gastrointestinal bleeding, or a documented ulcer within the past three months 3. History of bleeding tendencies, or any significant hematologic disease that may be associated with bleeding (e.g., thrombocytopenia ( 180/100 mmHg; 6. Patients weighing less than 50 kg (111 lbs) or weight greater than 120 kg (265 lbs); 7. Patients on long-term anticoagulants-e.g. heparin (unfractionated or low molecular weight), or have received therapeutic doses of an anticoagulant within three days prior to study treatment; require ongoing treatment with a vitamin K antagonist or concomitant use of aspirin, NSAIDs with a half-life >20 hours, proton pump inhibitors or antacids; 8. Patients with contraindications to venography such as; 1. Renal dysfunction as evidenced by creatinine (defined as >1.5 mg/dl or >132 ?mol/L) 2. History of allergy to iodine or radiopaque dye; 3. Inadequate pedal veins for cannulation for venography. 9. Patients with a past medical history of venous thromboembolism; 10. Patients with impaired hepatic function, as shown by any of the following; • SGOT/AST ? 3 times the upper limit of the reference range • SGPT/ALT ? 3 times the upper limit of the reference range • Alkaline phosphatase ? 2 times the upper limit of the reference range • Abnormal prothrombin time (>1.5 times baseline control) at study entry • Bilirubin >2 times the upper limit of reference range; 11. Spinal or epidural anesthesia with traumatic puncture or catheter placement or with prolonged bleeding from the puncture site; 12. Patients who have received any investigational drug within 1 month prior to study entry or such treatment is planned during the study period; 13. Patients with any concomitant condition, including clinically relevant cardiovascular, neurologic, endocrine, metastatic or hematological malignancy; or other major systemic disease that make implementation of the protocol or interpretation of the study results difficult; 14. Immunocompromised patients, such as patients with HIV infection; 15. Patients unlikely to comply with the protocol, (e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study); 16. Currently receiving treatment with any other investigational drug or experimental device; 17. Known to be pregnant (all women of childbearing potential require a negative pregnancy test [?-HCG] within 6 weeks or less prior to surgery); 18. Lactating women 19. Failure to provide informed consent and HIPAA authorization (USA subjects only) prior to enrollment into the study. 20. Patients with a positive screening result for hepatitis A immunoglobulin M, he
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the relationship between the dose of DU-176b and the occurrence of venous thromboembolism and bleeding in patients undergoing total hip replacement surgery;Secondary Objective: To assess the pharmacokinetics of DU-176b and its effects on coagulation parameters.;Primary end point(s): The primary endpoint is the incidence of confirmed venous thromboembolism. The secondary endpoint is the incidence of major bleeding. | — |
Countries
Latvia, United Kingdom
Outcome results
None listed