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

NCT00306254 | Completed Phase 2

• 1 other identifier: A5571010
• Study Type: interventional
• Target: 1,225
• Locations: 16 countries
• Sites: 134

Brief Summary

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

Conditions

Venous Thrombosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

Interventions

PD 0348292 DRUG

Enoxaparin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (134)

Pfizer Investigational Site

Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 35209, United States

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Little Rock, Arkansas, 72205, United States

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North Little Rock, Arkansas, 72118, United States

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Encinitas, California, 92024, United States

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Fountain Valley, California, 92708-4004, United States

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Fountain Valley, California, 92708, United States

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Glendale, California, 91206, United States

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La Mesa, California, 91942, United States

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Long Beach, California, 90806, United States

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Long Beach, California, 90813, United States

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Long Beach, California, 92708, United States

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Los Angeles, California, 90036, United States

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Los Angeles, California, 90045, United States

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Los Angeles, California, 90048, United States

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Santa Ana, California, 92704, United States

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Torrance, California, 90509, United States

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Aurora, Colorado, 80011, United States

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Aurora, Colorado, 80012, United States

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Aurora, Colorado, 80013, United States

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Denver, Colorado, 80230, United States

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Englewood, Colorado, 80110, United States

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Littleton, Colorado, 80122, United States

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Littleton, Colorado, 80123, United States

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Lone Tree, Colorado, 80123, United States

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Lone Tree, Colorado, 80124, United States

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Parker, Colorado, 80138, United States

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Coral Gables, Florida, 33134, United States

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Hollywood, Florida, 33021, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33136, United States

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Miami, Florida, 33175, United States

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Miami, Florida, 33186, United States

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Orlando, Florida, 32804, United States

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St. Petersburg, Florida, 33701, United States

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St. Petersburg, Florida, 33703, United States

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St. Petersburg, Florida, 33705, United States

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St. Petersburg, Florida, 33707, United States

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Winter Park, Florida, 32789, United States

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Winter Park, Florida, 32792, United States

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Flint, Michigan, 48503, United States

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Flint, Michigan, 48507, United States

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Rochester, New York, 14620, United States

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Hershey, Pennsylvania, 17033, United States

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Charleston, South Carolina, 29401, United States

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Charleston, South Carolina, 29414, United States

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Dallas, Texas, 75231, United States

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Fort Worth, Texas, 76104, United States

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Fort Worth, Texas, 76107, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77025, United States

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Houston, Texas, 77030, United States

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Lubbock, Texas, 79410, United States

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San Antonio, Texas, 78217, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78233, United States

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San Antonio, Texas, 78240, United States

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San Antonio, Texas, 78258, United States

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Caringbah, New South Wales, 2229, Australia

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Kogarah, New South Wales, 2217, Australia

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St Leonards, New South Wales, 2065, Australia

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Bedford Park, South Australia, 5042, Australia

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Daw Park, South Australia, 5041, Australia

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Box Hill, Victoria, 3128, Australia

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Clayton, Victoria, 3168, Australia

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Dandenong, Victoria, 3175, Australia

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East Bentleigh, Victoria, 3165, Australia

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Nedlands, Western Australia, 6009, Australia

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West Perth, Western Australia, 6005, Australia

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Red Deer, Alberta, T4N 4E7, Canada

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Kelowna, British Columbia, V1Y 1T2, Canada

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Guelph, Ontario, N1E 4J4, Canada

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Hamilton, Ontario, L8N 4A6, Canada

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Kitchener, Ontario, N2G 1G3, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Thunder Bay, Ontario, P7B 6V4, Canada

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Thunder Bay, Ontario, P7B 7C7, Canada

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Weston, Ontario, M9N 1N8, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Québec, Quebec, G1J 1Z4, Canada

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Santiago, RM, 8380419, Chile

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Medellín, Antioquia, 0, Colombia

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Barranquilla, Atlántico, 0, Colombia

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Floridablanca, Santander Department, 0, Colombia

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Cali, Valle del Cauca Department, 0, Colombia

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Brno, 663 50, Czechia

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Chomutov, 430 12, Czechia

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Hradec Králové, 500 05, Czechia

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Jihlava, 586 33, Czechia

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Kladno, 272 59, Czechia

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Pardubice, 532 03, Czechia

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Prague, 150 06, Czechia

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Prague, 169 02, Czechia

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Prague, 180 81, Czechia

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Třebíč, 674 01, Czechia

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Uherské Hradiště, 686 68, Czechia

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Hellerup, 2900, Denmark

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Hoersholm, 2970, Denmark

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Hvidovre, 2650, Denmark

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Kjellerup, 8620, Denmark

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Kolding, 6000, Denmark

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Silkeborg, 8700, Denmark

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Viborg, 8800, Denmark

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Nice, 06200, France

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Paris, 75013, France

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Bologna, 40136, Italy

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Genova, 16132, Italy

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Piacenza, 29100, Italy

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Bialystok, Poland

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Bytom, 41-902, Poland

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Piekary Śląskie, 41-940, Poland

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Sosnowiec, 41-200, Poland

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Warsaw, 00-909, Poland

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Warsaw, 03-242, Poland

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Wroclaw, 50-043, Poland

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Coimbra, 3000-075, Portugal

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Parede, 2779-502, Portugal

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Setúbal, 2900-182, Portugal

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Saint Petersburg, 193312, Russia

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Saint Petersburg, 195427, Russia

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Samara, 443095, Russia

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Yaroslavl, 150003, Russia

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Košice, 04011, Slovakia

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Cape Town, 7405, South Africa

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Johannesburg, 2013, South Africa

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Johannesburg, 2193, South Africa

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Barcelona, BARCELONA, 08024, Spain

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Barcelona, BARCELONA, 08035, Spain

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Barcelona, BARCELONA, 08036, Spain

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Alcorcón, Madrid, 28922, Spain

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Madrid, Madrid, 28040, Spain

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Mirasierra, Madrid, 28034, Spain

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Epsom, Surrey, KT18 7EG, United Kingdom

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London, SE5 9PJ, United Kingdom

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Venous Thrombosis

Interventions

N-(4-chlorophenyl)-N-(2-fluoro-4-(2-oxopyridin-1(2H)-yl)phenyl)-4-methoxypyrrolidiine-1,2-dicarboxamide; Enoxaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 23, 2006
• Study Start: March 1, 2006
• Study Completion: July 1, 2007
• Last Updated: October 10, 2007

Record last verified: 2007-10

Locations

SL (1); CO (4); AU (11); CL (1); CA (11); ZA (3); PL (7); ES (6); IT (3); FR (2); RU (4); GB (2); US (58); CZ (11); DK (7); PT (3)