EUCTR2005-005179-14-GB进行中（未招募）1 期
A phase 2b, randomized, multicenter, dose-ranging study assessing the safety and efficacy of PD 0348292 in the prevention of venous thromboembolic events (VTE) in subjects undergoing an elective, unilateral total knee replacement (protocol A5571010) - N/A
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,225
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •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 (women who have had bilateral oophorectomy or bilateral tubal ligation may participate in this study).
- •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
排除标准
- •Subjects presenting with any of the following will not be included in the trial:
- •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 within the past year of DVT, PE, suspected postthrombotic state, intracranial or intraocular bleeding, gastrointestinal bleeding and/or endoscopically verified ulcer disease;
- •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.Anticipated 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 (= moderate and confirmed by central lab) or significant proteinuria (4+) at screening;
- •7.Uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic >100 mm Hg) (at time of randomization);
- •8.Clinical laboratory evidence of anemia (hemoglobin level <10.0 g/dL) or thrombocytopenia (platelet count <100 × 103/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 creatinine clearance <30 mL/min);
- •11.Active hepatic disease (defined as transaminase = 3 × ULN or bilirubin = 1.5 × ULN) or history of hepatic insufficiency;
- •12.DSM-IV or local standard diagnosis of drug or alcohol abuse (meets criteria within the preceding past year);
- •13.Cancer (except for non melanoma skin cancer) or cytotoxic treatment for active malignancy (cancer includes blood dyscrasias, eg, acute or chronic leukemia);
- •14.An immunocompromised status (eg, receiving immunosuppressive therapy, a documented immunohumoral or cellular immune deficiency state, AIDS, or a history of being HIV positive);
- •15.Ischemic stroke or myocardial infarction (MI) within the 3 months prior to randomization;
- •16.Surgery/trauma within 6 months or a diagnostic arthroscopy within 6 weeks of surgery prior to randomization;
- •17.Immobilization (mainly confined to bed during waking hours/nonambulatory) for 3 or more days prior to randomization;
- •18.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;
- •19.Significant within the previous year, potential bleeding risks such as recurrent gastrointestinal ulcers, epistaxis, and cystitis;
- •20.Subjects with any condition possibly affecting drug absorption (eg, gastrectomy);
- •21.Anticoagulation/direct thrombin inhibitors/thrombolytic therapy administered or completed within 7 days before surgery or during the study treatment period. Subjects having an existing condition requiring long-term anticoagulation therapy should not
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