Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery
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|ClinicalTrials.gov Identifier: NCT00306254|
Recruitment Status : Completed
First Posted : March 23, 2006
Last Update Posted : October 10, 2007
|Condition or disease||Intervention/treatment||Phase|
|Venous Thrombosis||Drug: PD 0348292 Drug: Enoxaparin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1225 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||March 2006|
|Actual Study Completion Date :||July 2007|
- The primary efficacy endpoint is the incidence of total venous thromboembolism (including all proximal and distal deep vein thrombosis [DVT] and pulmonary embolism [PE])
- The primary safety endpoint is the incidence of total bleeding.
- Secondary efficacy endpoints are incidence of proximal DVT, distal DVT, and PE.
- Secondary safety endpoints are incidence of major and minor bleeding, all-cause mortality, abnormal liver function test elevation, adverse events and serious adverse events, and changes in clinical laboratory parameters.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306254
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|