Prevention of venous thromboembolism (VTE) after total hip replacement MedDRA version: 8.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis
Conditions
Interventions
Product Name: DU-176b
Product Code: DU-176b
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: DU-176b
Concentration unit: mg
Sponsors
Daiichi Sankyo Pharma Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria for inclusion in the study: 18 years of age or older; male or female. Able to provide written informed consent. Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted. If female, must be either one year post-menopausal, surgically sterile, or using medically accepted contraceptive measures as judged by the Investigator and in accordance with local regulatory requirements. 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: Subjects who meet any of the following preoperative exclusion criteria will be excluded from the study: Cancelled hip replacement surgery. Subjects with traumatic hip fracture undergoing primary surgical treatment. Subjects with known or suspected hereditary or acquired bleeding or coagulation disorder or at increased risk for thromboembolic events (eg, subject with past medical history of VTE). Subjects with an increased risk of bleeding. - Hemorrhagic stroke or conditions predisposing to intracranial hemorrhage (eg, previous intra-ocular hemorrhage or non-hemorrhagic stroke within the past 3 months, intracranial malignancy). - Gastrointestinal bleeding or a documented ulcer within the past 3 months. - Abnormal preoperative baseline PT or aPTT. Uncontrolled hypertension defined as systolic blood pressure (BP)>180 mmHg and/or diastolic BP>110 mmHg. Subjects on long-term oral anticoagulants (vitamin K antagonist) or who have received therapeutic doses of an anticoagulant or fibrinolytic agent within 10 days prior to study treatment. Subjects requiring ongoing treatment with an anti-platelet agent, including nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin (>100 mg/day excluded), clopidogrel, ticlopidine, and dypyrimadole. Subjects with a hypersensitivity to dalteparin, heparin, or pork products. Subjects with contraindications to venography including: - Renal dysfunction defined as serum creatinine >132 µmol/L - History of allergy to iodine or radiopaque dye - Inadequate dorsal pedal veins for cannulation for the venography procedure Subjects with anemia defined as hemoglobin (Hgb) <90 g/L or thrombocytopenia defined as platelet count <100 × 109/L. Subjects with impaired hepatic function, as shown by any of the following: - AST = 1.5 times the upper limit of the reference range - ALT = 1.5 times the upper limit of the reference range - Bilirubin = 1.5 times the upper limit of the reference range - Gamma glutamyl transpeptidase (GGT) = two times the upper limit of the reference range Subjects with positive Hepatitis A, B, or C serology. Subjects with a known drug or alcohol dependence within the past 12 months as defined by the Investigator. Subjects known to be pregnant or lactating. Subjects unable to complete the study requirements due to a clinically relevant concomitant disease as defined by the Investigator. Subjects with a disease that gives an estimated life survival of less than 12 months as judged by the Investigator. Subjects who have received an investigational drug within one month prior to study entry or are planning any such treatment. Subjects previously enrolled in a DU-176b study. Subjects unlikely to comply with the protocol (eg, uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study). Subjects will be assessed post-operatively for the following exclusion criteria and will be ineligible for this study if any of these additional criteria are met:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE).; Secondary Objective: To compare the incidence of VTE and major and clinically relevant non-major bleeds of DU-176b to dalteparin and To assess the pharmacokinetic (PK) and pharmacodynamic (PD) properties of DU-176b. Assessment of all bleeding events, treatment-emergent adverse events (TEAEs), laboratory test values, vital signs, and electrocardiograms (ECGs) in the DU-176b and the dalteparin treatment groups. ; Primary end point(s): The primary endpoint is the incidence of confirmed VTE. | — |
Countries
Denmark, Latvia, United Kingdom
Outcome results
None listed