Prevention of Venous Thromboembolic Events MedDRA version: 8.0 Level: HLGT Classification code 10014523
Conditions
Interventions
Product Code: PD 0348292
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: N/A
CAS Number: 536748-46-6
Current Sponsor code: PD 0348292
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
PFIZER, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years; 2. Male or female; 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
Exclusion criteria
Exclusion criteria: 1. Females with a total body weight 160 mm Hg or diastolic>100 mm Hg); 8. Clinical laboratory evidence of anemia (hemoglobin level 40 or CLcr 450 msec and/or clinically significan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the dose of PD 0348292 that is equivalent to enoxaparin 30 mg BID for VTE in subjects undergoing an elective, unilateral TKR; To characterize the dose-response of PD 0348292 in subjects undergoing an elective, unilateral TKR with respect to efficacy and safety endpoints; To characterize the pharmacokinetics of PD 0348292 in subjects undergoing an elective, unilateral TKR.;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint is the incidence of total venous thromboembolic events (VTE) (proximal or distal deep vein thrombosis DVT, and/or pulmonary embolism PE) as determined by a central laboratory. VTE is defined as any postoperative lower extremity deep vein thrombus, or pulmonary embolism, occurring anytime during the treatment period in a symptomatic subject or within 12 hours of the last treatment dose in an asymptomatic subject. The primary safety endpoint is the incidence of total bleeding (defined as major and/or minor bleeding). Major bleeding is defined as fatal bleeding, a fall in hemoglobin =20 g/L, requiring transfusion of =2 units of packed red blood cells (RBCs), or required major urgent surgical intervention performed. Minor bleeding is defined as any bleeding that is symptomatic requiring minor intervention (eg, manual compression, cauterization, irrigation, or compressive packing). | — |
Countries
Austria, Czech Republic, Denmark, Italy, Portugal, Slovakia, Spain, United Kingdom
Outcome results
None listed