Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00306254

Purpose

To study the safety and effectiveness of several doses of PD 0348292 compared to enoxaparin in preventing blood clots in the lungs or deep leg veins of patients after knee surgery

Condition	Intervention	Phase
Venous Thrombosis	Drug: PD 0348292 Drug: Enoxaparin	Phase II

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 Outcome Measures:

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.

Estimated Enrollment:	1225
Study Start Date:	March 2006
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult men or women scheduled for an elective, unilateral total knee replacement who are otherwise healthy.

Exclusion Criteria:

History of deep vein thrombosis or pulmonary embolism, suspected postthrombotic state, bleeding or clotting disorders, or cardiovascular, renal or liver disease within the past year

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306254

Show 135 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	A5571010
Study First Received:	March 21, 2006
Last Updated:	October 5, 2007
ClinicalTrials.gov Identifier:	NCT00306254
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Embolism and Thrombosis
Pulmonary Embolism
Embolism
Vascular Diseases

Venous Thrombosis
Thrombosis
Enoxaparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009