A Phase 2B, Randomized, Multicenter, Dose-Ranging Study Assessingthe Safety and Efficacy of PD 0348292 in the Prevention of Venous ThromboembolicEvents (VTE) in Subjects Undergoing an Elective, Unilateral Total Knee Replacement - N/A
- Conditions
- Prevention of Venous Thromboembolic EventsMedDRA version: 8.0Level: HLGTClassification code 10014523
- Registration Number
- EUCTR2005-005179-14-DK
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1255
1. Age =18 years;
2. Male or female; if male, must agree to use an acceptable method of birth control (eg. using condoms) if sexually active during study treatment; if female must meet at least 1 of the following criteria:
·Greater than or equal to 2 years postmenopausal or
·Surgically sterilized
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
4. Scheduled for an elective, unilateral TKR;
5. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
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. Females with a total body weight <45 kg or males with a total body weight <57 kg;
2. Subjects scheduled for a hemiarthroplasty, surface repair or revisionary surgery of the knee;
3. History of DVT, PE, suspected postthrombotic state, intracranial or intraocular bleeding, gastrointestinal bleeding and/or endoscopically verified ulcer disease within the past year;
4. History of, or in the opinion of the investigator, potential risk for traumatic or repeated epidural or spinal puncture (refer to spinal/epidural hematomas warning in enoxaparin sodium injection package insert);
5. Potential risk of extended use of indwelling epidural catheters for more than 6 hours after surgery or within 2 hours of administration of the first dose of study medication;
6. Positive urine dipstick for blood or significant proteinuria (4+) at screening or prior to surgery;
7. History of uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic>100 mm Hg);
8. Clinical laboratory evidence of anemia (hemoglobin level <10.0 g/dL) or thrombocytopenia (platelet count <100x103/µL);
9. Constitutional or acquired coagulation disorders that in the investigator’s judgment puts the subject at excessive risk for bleeding.
10. Severe renal dysfunction, nephrotic syndrome or dysproteinemias (defined as on dialysis or serum creatinine =1.8 mg/dL, blood urea nitrogen (BUN) >40 or CLcr <30 mL/min);
11. Active hepatic disease (defined as transaminase = 3 x ULN or bilirubin =1.5 x ULN) or history of hepatic insufficiency;
12. DSM-IV or local standard diagnosis of Substance Related Disorders (meets criteria within the preceding past year);
13. Cancer (except for non melanoma skin cancer) or cytotoxic treatment for active malignancy;
14. Ischemic stroke or myocardial infarction (MI) within the 3 months prior to randomization;
15. Surgery/trauma within 6 months or a diagnostic arthroscopy within 6 weeks of surgery prior to randomization;
16. Immobilization (mainly confined to bed during waking hours/nonambulatory) for 3 or more days prior to randomization;
17. In the opinion of the clinical investigator, subjects potentially at risk of bleeding after minor interventions such as dental treatment, mole removal, or similar interventions within 6 weeks prior to randomization;
18. Significant within the previous year, potential bleeding risks such as recurrent gastrointestinal ulcers, epistaxis, and cystitis;
19. Subjects with any condition possibly affecting drug absorption (eg, gastrectomy);
20. Anticoagulation/direct thrombin inhibitors/thrombolytic therapy administered or completed within 7 days before surgery or during the entire duration of the study period. Subjects requiring long-term anticoagulation therapy should not be included;·Medications known to affect platelet function or coagulation including: Vitamin K antagonists, unfractionated heparin and derivatives, low molecular weight heparins (LMWH) (except those investigated in the study or used in connection with the intraoperative salvage of RBCs), fondaparinux, desirudin, thrombolytic agents, dipyridamole, sulphinpyrazone, GP IIb/IIIa receptor antagonists, clopidogrel, ticlopidine, nonsteroidal anti-inflammatory drugs (NSAIDs) with half-life>20 hours, acetyl salicylic acid, and dextran.
21. History of significant adverse reaction (eg, heparin- or LMWH-induced thrombocytopenia) to an anticoagulant;
22. Hypersensitivity to enoxaparin sodium, heparin, or pork products;
23. Known allergy to contrast media or
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method