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PD 0348292

Phase 2

Venous Thrombosis | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: Oct 10, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment1,225

FDA Designations

No designations recorded

Clinical trial landscape

PD 0348292 · 1 trial · 1 indication

Phase 2 1
NCT00306254Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee SurgeryVenous Thrombosis
COMPLETED1,225 Analytics
PHASE2COMPLETED
Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery
Venous Thrombosis
NCT003062541,225
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Study Endpoints

Primary Endpoints

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 Endpoints

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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
PD 0348292DRUG -
EnoxaparinDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites134

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...

Countries:United StatesAustraliaCanadaChileColombiaCzechiaDenmarkFranceItalyPolandPortugalRussiaSlovakiaSouth AfricaSpainUnited Kingdom
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Frequently asked questions about PD 0348292

What is PD 0348292 used for?

PD 0348292 is an investigational small molecule being developed for venous thrombosis, a condition involving blood clots in the veins. It was studied for preventing blood clots in the lungs or deep leg veins of patients after knee surgery. The drug is in Phase 2 clinical development.

Who makes PD 0348292?

PD 0348292 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in Phase 2 clinical development for venous thrombosis.

What phase is PD 0348292 in?

PD 0348292 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for venous thrombosis.

What clinical trials is PD 0348292 in?

PD 0348292 has one completed Phase 2 clinical trial, identified as NCT00306254. This trial evaluated the drug for preventing blood clots in the lungs or deep leg veins of patients after knee surgery. The trial enrolled 1,225 participants across multiple countries.

Was the PD 0348292 clinical trial randomized and double-blind?

The Phase 2 clinical trial of PD 0348292, NCT00306254, was randomized and double-blind. The trial enrolled 1,225 participants and was conducted in the United States, Australia, Canada, Chile, Colombia, Czechia, Denmark, France, Italy, Poland, Portugal, Russia, Slovakia, South Africa, Spain, and the United Kingdom.