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

Phase 1

Conditions: Prevention of Venous Thromboembolic Events
MedDRA version: 8.1 Level: HLGT Classification code 10014523 Term: Embolism and thrombosis

Registration Number: EUCTR2005-005179-14-GB

Lead Sponsor: Pfizer Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 1225

Inclusion Criteria

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

Exclusion Criteria

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

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

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