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Study of an Investigational Drug for the Prevention of Thrombosis-Related Events Following Knee Replacement Surgery (ADVANCE-2)
This study is currently recruiting participants.
Verified by Bristol-Myers Squibb, February 2009
First Received: March 23, 2007   Last Updated: March 6, 2009   History of Changes
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00452530
  Purpose

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots.

The safety of apixaban will also be studied.


Condition Intervention Phase
Deep Vein Thrombosis
Pulmonary Embolism
 Drug: Enoxaparin + Placebo
Drug: Apixaban + Placebo
 Phase III

MedlinePlus related topics: Deep Vein Thrombosis Knee Replacement Pulmonary Embolism Surgery
Drug Information available for: Apixaban Enoxaparin Sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Active Control, Double Blind (Subject, Investigator), Parallel Assignment, Randomized, Safety/Efficacy Study, Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Active-Controlled (Enoxaparin 40 mg QD), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study)

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • A combination of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death [ Time Frame: after 12 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A combination of adjudicated asymptomatic and symptomatic proximal DVT, non-fatal PE, & VTE-related death [ Time Frame: after 12 days of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 3058
Study Start Date: June 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A1: Active Comparator
+ placebo
Drug: Enoxaparin + Placebo
Syringes + tablets, Subcutaneous + Oral, 40 mg, once daily, 12 days
A2: Experimental
+ placebo
Drug: Apixaban + Placebo
Tablet + Syringes, Oral + subcutaneous, 2.5mg, twice daily, 12 days

  Eligibility

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

Inclusion Criteria:

  • men and non-pregnant, non-breastfeeding women
  • 18 years or older
  • scheduled for total knee replacement surgery

Exclusion Criteria:

  • hereditary or acquired bleeding disorders
  • clotting disorders
  • bleeding or high risk for bleeding
  • drugs that affect bleeding or coagulation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452530

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Hide Study Locations
Locations
Austria
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Wien, Austria, 1090
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Linz, Austria, 4010
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Innsbruck, Austria, 6020
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Wiener Neustadt, Austria, 2700
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Wien, Austria, 1130
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Graz, Austria, 8036
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Wels, Austria, 4600
Belgium
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Antwerpen, Belgium, 2020
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Hasselt, Belgium, 3500
Brazil
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Sao Paulo, Brazil, 04023
Brazil, Minas Gerais
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Belo Horizonte - Mg, Minas Gerais, Brazil, 30130
Chile, Metropolitana
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Santiago, Metropolitana, Chile, 7500922
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Santiago, Metropolitana, Chile, 8330033
China
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Beijing, China, 100035
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Beijing, China, 100835
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Shanghai, China, 200025
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Shanghai, China, 200233
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Shanghai, China, 200011
China, Shandong
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Qingdao, Shandong, China, 266003
Colombia
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Medelin, Colombia, -----
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Bogota, Colombia
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Bogota, Colombia, XXXXX
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Bogota, Colombia
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Cali, Colombia, - - - - -
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Barranquilla, Colombia, - - - - -
Contact: Site 171            
Czech Republic
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Prague 8, Czech Republic, 180 81
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Pardubice, Czech Republic, 532 03
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Chomutov, Czech Republic, 430 12
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Brno, Czech Republic, 662 50
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Uherske Hradiste, Czech Republic, 686 68
Denmark
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Hellerup, Denmark, 2900
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Kolding, Denmark, 6000
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Viborg, Denmark, 8800
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Hvidovre, Denmark, 2650
France
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Paris, France, 75019
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Monaco, France, 98000
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Nice, France, 06200
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Paris, France, 75679
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Saint-Saulve, France, 59880
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Paris, France, 75014
Germany
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Rheinfelden, Germany, 79618
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Frankfurt Am Main, Germany, 60528
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Bad Mergentheim, Germany, 97980
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Brandenburg, Germany, 14770
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Frankfurt, Germany, 65929
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Bochum, Germany, 44791
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Dresden, Germany, 01307
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Witten, Germany, 58455
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Kremmen Ot Sommerfeld, Germany, 16766
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Halle/S, Germany, 06112
Hungary
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Szeged, Hungary, 6725
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Szekszard, Hungary, 7100
India
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Bangalore, India, 560034
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Mangalore, India, 575001
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Baroda, India, 390007
India, Gujarat
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Ahmedabad, Gujarat, India, 380054
India, Punjab
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Ludhiana, Punjab, India, 141001
Israel
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Tel Aviv, Israel, 64239
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Safed, Israel, 13110
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Tel Hashomer, Israel, 52621
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Petach-Tikva, Israel, 49372
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Jeruselem, Israel, 91031
Italy
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Bologna, Italy, 40136
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Pordenone, Italy, 33170
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Roma, Italy, 00168
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Abano Terme (Pd), Italy, 35031
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Roma, Italy, 00168
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San Donato Milanese (Mi), Italy, 20097
Korea, Republic of
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 136-705
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Jeonnam, Korea, Republic of, 519-809
Malaysia
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Kuala Lumpur, Malaysia, 56000
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Kuala Lumpur, Malaysia, 50586
Mexico
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Aguascalientes, Mexico, 20010
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San Luis Potosi, Mexico, 78340
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Veracruz, Mexico, 91700
Mexico, Jalisco
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Zapopan, Jalisco, Mexico, 45200
Mexico, Sonora
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Hermosillo, Sonora, Mexico, 83190
Norway
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Kongsvinger, Norway, 2212
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Alesund, Norway, 6026
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Gjettum, Norway, 1346
Philippines
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Quezon City, Philippines, 1102
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Quezon City, Philippines, 1114
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Manila, Philippines, 1000
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Manila, Philippines, 1000
Poland
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Warszawa, Poland, 03-242
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Gdansk, Poland, 80-803
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Wroclaw, Poland, 50-556
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Bytom, Poland, 41-902
Russian Federation
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Saint Petersburg, Russian Federation, 195427
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Kazan, Russian Federation, 420029
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Saint Petersburg, Russian Federation, 194354
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Saint Petersburg, Russian Federation, 199106
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Moscow, Russian Federation, 115522
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Samara, Russian Federation, 443095
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Saint Petersburg, Russian Federation, 193312
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Chelyabinsk, Russian Federation, 454021
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Rostov-Na-Donu, Russian Federation, 344010
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Lipetsk, Russian Federation, 398035
Singapore
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Singapore, Singapore, 169608
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Singapore, Singapore, 529889
South Africa, Free State
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Randburg, Free State, South Africa, 2194
South Africa, Gauteng
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Johannesburg, Gauteng, South Africa, 2193
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Pretoria, Gauteng, South Africa, 0083
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Johannesburg, Gauteng, South Africa, 2031
South Africa, Western Cape
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Tygerberg, Western Cape, South Africa, 7505
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Somerset West, Western Cape, South Africa, 7130
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Worcester, Western Cape, South Africa, 6850
Spain
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Barcelona, Spain, 08035
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Badalona-Barcelona, Spain, 08916
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Barcelona, Spain, 08006
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Valencia, Spain, 46010
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Santiago De Compostela, Spain, 15706
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Madrid, Spain, 28034
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Barcelona, Spain, 08024
Sweden
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Boras, Sweden, 501 82
Ukraine
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Cherkassy, Ukraine, 18009
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Kyiv, Ukraine, 01601
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Dnipropetrovsk, Ukraine, 49005
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Sevastopol, Ukraine, 99018
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Kyiv, Ukraine, 04107
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Chernivtsy, Ukraine, 58013
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Ivano-Frankivsk, Ukraine, 76008
United Kingdom, Greater London
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London, Greater London, United Kingdom, SE5 9PJ
United Kingdom, Surrey
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Epsom, Surrey, United Kingdom, KT18 7EG
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CV185-047, EUdraCT: 2006-006896-19
Study First Received: March 23, 2007
Last Updated: March 6, 2009
ClinicalTrials.gov Identifier: NCT00452530     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery

Study placed in the following topic categories:
Pulmonary Embolism
Anticoagulants
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Thrombosis
Enoxaparin
 Embolism and Thrombosis
Fibrin Modulating Agents
Respiratory Tract Diseases
Embolism
Lung Diseases
Venous Thrombosis

Additional relevant MeSH terms:
Pulmonary Embolism
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Thrombosis
 Enoxaparin
Fibrin Modulating Agents
Embolism and Thrombosis
Respiratory Tract Diseases
Embolism
Lung Diseases
Therapeutic Uses
Venous Thrombosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on March 16, 2009



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