Venous ThrombosisPhase 2NCT00306254
Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery
A Phase 2 study testing PD 0348292 and Enoxaparin in people with Venous Thrombosis, run by Pfizer at 134 sites in 16 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- PD 0348292 and Enoxaparin
- How many people
- 1,225 participants
- Where
- 134 sitesin 16 countries
- Study dates
- Mar 2006to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women scheduled for an elective, unilateral total knee replacement who are otherwise healthy.
Who cannot join
- 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
Trial locations and contacts
134 sites in 16 countries.
134 sites in 16 countries
United States58 sites
Pfizer Investigational Site
Aurora, Colorado, 80011
Pfizer Investigational Site
Aurora, Colorado, 80012
Pfizer Investigational Site
Aurora, Colorado, 80013
Pfizer Investigational Site
Birmingham, Alabama, 35205
Pfizer Investigational Site
Birmingham, Alabama, 35209
Pfizer Investigational Site
Charleston, South Carolina, 29401
Pfizer Investigational Site
Charleston, South Carolina, 29414
Pfizer Investigational Site
Coral Gables, Florida, 33134
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Denver, Colorado, 80230
Pfizer Investigational Site
Encinitas, California, 92024
Pfizer Investigational Site
Englewood, Colorado, 80110
Pfizer Investigational Site
Flint, Michigan, 48503
Pfizer Investigational Site
Flint, Michigan, 48507
Pfizer Investigational Site
Fort Worth, Texas, 76104
Pfizer Investigational Site
Fort Worth, Texas, 76107
Pfizer Investigational Site
Fountain Valley, California, 92708-4004
Pfizer Investigational Site
Fountain Valley, California, 92708
Pfizer Investigational Site
Glendale, California, 91206
Pfizer Investigational Site
Hershey, Pennsylvania, 17033
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Houston, Texas, 77025
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
La Mesa, California, 91942
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Littleton, Colorado, 80122
Pfizer Investigational Site
Littleton, Colorado, 80123
Pfizer Investigational Site
Lone Tree, Colorado, 80123
Pfizer Investigational Site
Lone Tree, Colorado, 80124
Pfizer Investigational Site
Long Beach, California, 90806
Pfizer Investigational Site
Long Beach, California, 90813
Pfizer Investigational Site
Long Beach, California, 92708
Pfizer Investigational Site
Los Angeles, California, 90036
Pfizer Investigational Site
Los Angeles, California, 90045
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
Lubbock, Texas, 79410
Pfizer Investigational Site
Miami, Florida, 33125
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Miami, Florida, 33175
Pfizer Investigational Site
Miami, Florida, 33186
Pfizer Investigational Site
North Little Rock, Arkansas, 72118
Pfizer Investigational Site
Orlando, Florida, 32804
Pfizer Investigational Site
Parker, Colorado, 80138
Pfizer Investigational Site
Rochester, New York, 14620
Pfizer Investigational Site
San Antonio, Texas, 78217
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78233
Pfizer Investigational Site
San Antonio, Texas, 78240
Pfizer Investigational Site
San Antonio, Texas, 78258
Pfizer Investigational Site
Santa Ana, California, 92704
Pfizer Investigational Site
St. Petersburg, Florida, 33701
Pfizer Investigational Site
St. Petersburg, Florida, 33703
Pfizer Investigational Site
St. Petersburg, Florida, 33705
Pfizer Investigational Site
St. Petersburg, Florida, 33707
Pfizer Investigational Site
Torrance, California, 90509
Pfizer Investigational Site
Winter Park, Florida, 32789
Pfizer Investigational Site
Winter Park, Florida, 32792
Australia11 sites
Pfizer Investigational Site
Bedford Park, South Australia, 5042
Pfizer Investigational Site
Box Hill, Victoria, 3128
Pfizer Investigational Site
Caringbah, New South Wales, 2229
Pfizer Investigational Site
Clayton, Victoria, 3168
Pfizer Investigational Site
Dandenong, Victoria, 3175
Pfizer Investigational Site
Daw Park, South Australia, 5041
Pfizer Investigational Site
East Bentleigh, Victoria, 3165
Pfizer Investigational Site
Kogarah, New South Wales, 2217
Pfizer Investigational Site
Nedlands, Western Australia, 6009
Pfizer Investigational Site
St Leonards, New South Wales, 2065
Pfizer Investigational Site
West Perth, Western Australia, 6005
Canada11 sites
Pfizer Investigational Site
Guelph, Ontario, N1E 4J4
Pfizer Investigational Site
Hamilton, Ontario, L8N 4A6
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 1T2
Pfizer Investigational Site
Kitchener, Ontario, N2G 1G3
Pfizer Investigational Site
Montreal, Quebec, H1T 2M4
Pfizer Investigational Site
Ottawa, Ontario, K1H 8L6
Pfizer Investigational Site
Québec, Quebec, G1J 1Z4
Pfizer Investigational Site
Red Deer, Alberta, T4N 4E7
Pfizer Investigational Site
Thunder Bay, Ontario, P7B 6V4
Pfizer Investigational Site
Thunder Bay, Ontario, P7B 7C7
Pfizer Investigational Site
Weston, Ontario, M9N 1N8
Czechia11 sites
Pfizer Investigational Site
Brno, 663 50
Pfizer Investigational Site
Chomutov, 430 12
Pfizer Investigational Site
Hradec Králové, 500 05
Pfizer Investigational Site
Jihlava, 586 33
Pfizer Investigational Site
Kladno, 272 59
Pfizer Investigational Site
Pardubice, 532 03
Pfizer Investigational Site
Prague, 150 06
Pfizer Investigational Site
Prague, 169 02
Pfizer Investigational Site
Prague, 180 81
Pfizer Investigational Site
Třebíč, 674 01
Pfizer Investigational Site
Uherské Hradiště, 686 68
Denmark7 sites
Pfizer Investigational Site
Hellerup, 2900
Pfizer Investigational Site
Hoersholm, 2970
Pfizer Investigational Site
Hvidovre, 2650
Pfizer Investigational Site
Kjellerup, 8620
Pfizer Investigational Site
Kolding, 6000
Pfizer Investigational Site
Silkeborg, 8700
Pfizer Investigational Site
Viborg, 8800
Poland7 sites
Pfizer Investigational Site
Bialystok
Pfizer Investigational Site
Bytom, 41-902
Pfizer Investigational Site
Piekary Śląskie, 41-940
Pfizer Investigational Site
Sosnowiec, 41-200
Pfizer Investigational Site
Warsaw, 00-909
Pfizer Investigational Site
Warsaw, 03-242
Pfizer Investigational Site
Wroclaw, 50-043
Spain6 sites
Pfizer Investigational Site
Alcorcón, Madrid, 28922
Pfizer Investigational Site
Barcelona, BARCELONA, 08024
Pfizer Investigational Site
Barcelona, BARCELONA, 08035
Pfizer Investigational Site
Barcelona, BARCELONA, 08036
Pfizer Investigational Site
Madrid, Madrid, 28040
Pfizer Investigational Site
Mirasierra, Madrid, 28034
Colombia4 sites
Pfizer Investigational Site
Barranquilla, Atlántico, 0
Pfizer Investigational Site
Cali, Valle del Cauca Department, 0
Pfizer Investigational Site
Floridablanca, Santander Department, 0
Pfizer Investigational Site
Medellín, Antioquia, 0
Russia4 sites
Pfizer Investigational Site
Saint Petersburg, 193312
Pfizer Investigational Site
Saint Petersburg, 195427
Pfizer Investigational Site
Samara, 443095
Pfizer Investigational Site
Yaroslavl, 150003
Italy3 sites
Pfizer Investigational Site
Bologna, 40136
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Piacenza, 29100
Portugal3 sites
Pfizer Investigational Site
Coimbra, 3000-075
Pfizer Investigational Site
Parede, 2779-502
Pfizer Investigational Site
Setúbal, 2900-182
South Africa3 sites
Pfizer Investigational Site
Cape Town, 7405
Pfizer Investigational Site
Johannesburg, 2013
Pfizer Investigational Site
Johannesburg, 2193
France2 sites
Pfizer Investigational Site
Nice, 06200
Pfizer Investigational Site
Paris, 75013
United Kingdom2 sites
Pfizer Investigational Site
Epsom, Surrey, KT18 7EG
Pfizer Investigational Site
London, SE5 9PJ
About this 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
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
- Being tested
- PD 0348292, Enoxaparin
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD 0348292Drug
EnoxaparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2006 (estimated)
- Study startMar 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,225 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306254
- Sponsor's protocol ID
- A5571010
- Status last verified
- Oct 2007
- First submitted
- 21 Mar 2006
- Last updated
- 10 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00306254
- Acronym / sponsor ID
- A5571010
- Conditions
- Venous Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,225 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 23 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult men or women scheduled for an elective, unilateral total knee replacement who are otherwise healthy.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD 0348292 | Drug | – |
| Enoxaparin | Drug | – |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2007.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
134 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD 0348292 and Enoxaparin in people with Venous Thrombosis, run by Pfizer at 134 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 134 sites in United States, Australia, Canada, Czechia, Denmark and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2007.