Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
NCT ID: NCT00679588
Last Updated: 2013-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
4413 participants
INTERVENTIONAL
2008-04-30
2010-08-31
Brief Summary
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The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.
Detailed Description
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The total duration of observation per participant is 35-42 days from surgery broken down as follows:
* 7 to 10-day double-blind treatment period;
* 28 to 35-day follow-up period.
Mandatory bilateral venography of the lower limbs has to be performed between 7 to 11 days after surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Semuloparin
Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment \[SRI\]) once daily for 7-10 days with an initial dose given 8 hours after surgery (placebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind)
Semuloparin Sodium
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection
Placebo
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component
Subcutaneous injection
Enoxaparin
Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment \[SRI\]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium (placebo for Semuloparin sodium 8 hours after surgery to maintain the blind)
Enoxaparin sodium
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection
Placebo
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component
Subcutaneous injection
Interventions
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Semuloparin Sodium
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection
Enoxaparin sodium
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection
Placebo
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component
Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient \<60 years of age had to have one of the following additional risk factors for VTE:
* History of VTE,
* Obesity,
* Chronic Heart failure,
* Chronic Respiratory Failure,
* Inflammatory Bowel Disease,
* Cancer Surgery.
Exclusion Criteria
* Clinical signs or symptoms of DVT or PE within the last 12 months or known post phlebitic syndrome;
* Any contra-indications to the performance of venography;
* High risk of bleeding;
* Known hypersensitivity to heparin or Enoxaparin sodium;
* End stage renal disease or patient on dialysis.
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Ajay Kakkar, Prof., MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen Mary's School of Medicine & Dentistry, London (UK)
Alexander Turpie, MD
Role: STUDY_CHAIR
HHS-General Hospital, Hamilton, Canada
Locations
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Investigational Site Number 840026
Birmingham, Alabama, United States
Investigational Site Number 840035
Birmingham, Alabama, United States
Investigational Site Number 840042
Birmingham, Alabama, United States
Investigational Site Number 840002
Birmingham, Alabama, United States
Investigational Site Number 840031
Corlton, California, United States
Investigational Site Number 840007
Huntingdon Beach, California, United States
Investigational Site Number 840014
Los Angeles, California, United States
Investigational Site Number 840011
Sant Barbara, California, United States
Investigational Site Number 840021
Denver, Colorado, United States
Investigational Site Number 840029
Clearwater, Florida, United States
Investigational Site Number 840017
Jacksonville, Florida, United States
Investigational Site Number 840044
Miami, Florida, United States
Investigational Site Number 840015
Orlando, Florida, United States
Investigational Site Number 840009
Columbus, Georgia, United States
Investigational Site Number 840019
Maywood, Illinois, United States
Investigational Site Number 840036
Springfield, Illinois, United States
Investigational Site Number 840037
Hazard, Kentucky, United States
Investigational Site Number 840008
St Louis, Missouri, United States
Investigational Site Number 840020
Teaneck, New Jersey, United States
Investigational Site Number 840051
Columbus, Ohio, United States
Investigational Site Number 840006
Pittsburgh, Pennsylvania, United States
Investigational Site Number 840025
Houston, Texas, United States
Investigational Site Number 840050
Houston, Texas, United States
Investigational Site Number 840032
Lubbock, Texas, United States
Investigational Site Number 840043
Morgantown, West Virginia, United States
Investigational Site Number 032002
Buenos Aires, , Argentina
Investigational Site Number 032001
Buenos Aires, , Argentina
Investigational Site Number 032004
Buenos Aires, , Argentina
Investigational Site Number 032007
Capital Federal, , Argentina
Investigational Site Number 032008
Capital Federal, , Argentina
Investigational Site Number 032014
Córdoba, , Argentina
Investigational Site Number 032012
Rosario, , Argentina
Investigational Site Number 032005
Santa Fe, , Argentina
Investigational Site Number 036002
Box Hill, , Australia
Investigational Site Number 036003
Box Hill, , Australia
Investigational Site Number 036001
Kogarah, , Australia
Investigational Site Number 036008
Redcliffe, , Australia
Investigational Site Number 040001
Graz, , Austria
Investigational Site Number 040002
Wels, , Austria
Investigational Site Number 112001
Homyel, , Belarus
Investigational Site Number 112006
Homyel, , Belarus
Investigational Site Number 112003
Minsk, , Belarus
Investigational Site Number 112008
Minsk, , Belarus
Investigational Site Number 112002
Minsk, , Belarus
Investigational Site Number 112005
Minsk, , Belarus
Investigational Site Number 112004
Vitebsk, , Belarus
Investigational Site Number 112007
Vitebsk, , Belarus
Investigational Site Number 056002
Genk, , Belgium
Investigational Site Number 056001
Ghent, , Belgium
Investigational Site Number 076003
Belo Horizonte, , Brazil
Investigational Site Number 076010
Belo Horizonte, , Brazil
Investigational Site Number 076014
Caxias do Sul, , Brazil
Investigational Site Number 076012
Curitiba, , Brazil
Investigational Site Number 076005
Curitiba, , Brazil
Investigational Site Number 076006
Goiânia, , Brazil
Investigational Site Number 076011
Joinville, , Brazil
Investigational Site Number 076007
Porto Alegre, , Brazil
Investigational Site Number 076009
Porto Alegre, , Brazil
Investigational Site Number 076015
Ribeirão Preto, , Brazil
Investigational Site Number 076013
São José do Rio Preto, , Brazil
Investigational Site Number 076004
São Paulo, , Brazil
Investigational Site Number 076002
São Paulo, , Brazil
Investigational Site Number 076008
São Paulo, , Brazil
Investigational Site Number 100004
Pleven, , Bulgaria
Investigational Site Number 100003
Rousse, , Bulgaria
Investigational Site Number 100011
Sofia, , Bulgaria
Investigational Site Number 100005
Sofia, , Bulgaria
Investigational Site Number 100008
Sofia, , Bulgaria
Investigational Site Number 100009
Sofia, , Bulgaria
Investigational Site Number 100006
Varna, , Bulgaria
Investigational Site Number 100010
Varna, , Bulgaria
Investigational Site Number 124001
Edmonton, , Canada
Investigational Site Number 124004
Kitchener, , Canada
Investigational Site Number 124010
Montreal, , Canada
Investigational Site Number 124011
Red Deer, , Canada
Investigational Site Number 124009
Saint John, , Canada
Investigational Site Number 124002
Thunder Bay, , Canada
Investigational Site Number 124007
Vancouver, , Canada
Investigational Site Number 152002
Rancagua, , Chile
Investigational Site Number 152001
Santiago, , Chile
Investigational Site Number 156011
Baotou, , China
Investigational Site Number 156012
Changsha, , China
Investigational Site Number 156010
Changsha, , China
Investigational Site Number 156006
Fuzhou, , China
Investigational Site Number 156003
Guangzhou, , China
Investigational Site Number 156013
Haikou, , China
Investigational Site Number 156005
Nanjing, , China
Investigational Site Number 156008
Qingdao, , China
Investigational Site Number 156001
Shijiazhuang, , China
Investigational Site Number 156014
Tianjin, , China
Investigational Site Number 156004
Xi'an, , China
Investigational Site Number 191004
Požega, , Croatia
Investigational Site Number 191001
Pula, , Croatia
Investigational Site Number 191002
Zagreb, , Croatia
Investigational Site Number 203007
Brno, , Czechia
Investigational Site Number 203001
Brno, , Czechia
Investigational Site Number 203011
Jihlava, , Czechia
Investigational Site Number 203015
Kolín, , Czechia
Investigational Site Number 203009
Kroměříž, , Czechia
Investigational Site Number 203004
Liberec, , Czechia
Investigational Site Number 203014
Most, , Czechia
Investigational Site Number 203003
Ostrava, , Czechia
Investigational Site Number 203012
Pardubice, , Czechia
Investigational Site Number 203008
Prague, , Czechia
Investigational Site Number 203006
Prague, , Czechia
Investigational Site Number 203002
Prague, , Czechia
Investigational Site Number 203016
Říčany, , Czechia
Investigational Site Number 203010
Ústí nad Labem, , Czechia
Investigational Site Number 208001
København NV, , Denmark
Investigational Site Number 208002
Odense C, , Denmark
Investigational Site Number 233003
Tallinn, , Estonia
Investigational Site Number 233001
Tartu, , Estonia
Investigational Site Number 233002
Tartu, , Estonia
Investigational Site Number 276011
Bochum, , Germany
Investigational Site Number 276015
Castrop-Rauxel, , Germany
Investigational Site Number 276018
Castrop-Rauxel, , Germany
Investigational Site Number 276006
Dresden, , Germany
Investigational Site Number 276012
Hanover, , Germany
Investigational Site Number 276002
Heidelberg, , Germany
Investigational Site Number 276004
Homburg, , Germany
Investigational Site Number 276014
Lübeck, , Germany
Investigational Site Number 276016
Magdeburg, , Germany
Investigational Site Number 276013
München, , Germany
Investigational Site Number 276001
Stralsund, , Germany
Investigational Site Number 300002
Heraklion, , Greece
Investigational Site Number 348007
Debrecen, , Hungary
Investigational Site Number 348009
Kistarcsa, , Hungary
Investigational Site Number 348008
Szeged, , Hungary
Investigational Site Number 348004
Székesfehérvár, , Hungary
Investigational Site Number 348003
Szolnok, , Hungary
Investigational Site Number 356005
Ahmedabad, , India
Investigational Site Number 356004
Ahmedabad, , India
Investigational Site Number 356033
Andhra Pradesh, , India
Investigational Site Number 356011
Bangalore, , India
Investigational Site Number 356027
Bangalore, , India
Investigational Site Number 356008
Bangalore, , India
Investigational Site Number 356019
Banglore, , India
Investigational Site Number 356031
Bhopal, , India
Investigational Site Number 356014
Chennai, , India
Investigational Site Number 356018
Chennai, , India
Investigational Site Number 356016
Chennai, , India
Investigational Site Number 356021
Chennai, , India
Investigational Site Number 356006
Coimbatore, , India
Investigational Site Number 356025
Gujarat, , India
Investigational Site Number 356028
Hyderabad, , India
Investigational Site Number 356010
Hyderabad, , India
Investigational Site Number 356002
Jaipur, , India
Investigational Site Number 356022
Jaipur, , India
Investigational Site Number 356013
Kochi, , India
Investigational Site Number 356007
Kochi, , India
Investigational Site Number 356003
Lucknow, , India
Investigational Site Number 356026
Lucknow, , India
Investigational Site Number 356032
Ludhiana, , India
Investigational Site Number 356001
Mangalore, , India
Investigational Site Number 356030
Nagpur, , India
Investigational Site Number 356009
New Delhi, , India
Investigational Site Number 356023
Pune, , India
Investigational Site Number 356015
Pune, , India
Investigational Site Number 356012
Punjgutta, , India
Investigational Site Number 380009
Aviano, , Italy
Investigational Site Number 380001
Genova, , Italy
Investigational Site Number 380015
Genova, , Italy
Investigational Site Number 380006
Milan, , Italy
Investigational Site Number 380004
Padua, , Italy
Investigational Site Number 380008
Parma, , Italy
Investigational Site Number 380013
Piacenza, , Italy
Investigational Site Number 380012
Pordenone, , Italy
Investigational Site Number 380005
Reggio Emilia, , Italy
Investigational Site Number 380011
San Donato Milanese, , Italy
Investigational Site Number 380007
Trieste, , Italy
Investigational Site Number 428004
Daugavpils, , Latvia
Investigational Site Number 428003
Riga, , Latvia
Investigational Site Number 428002
Riga, , Latvia
Investigational Site Number 440003
Kaunas, , Lithuania
Investigational Site Number 440001
Kaunas, , Lithuania
Investigational Site Number 440002
Vilnius, , Lithuania
Investigational Site Number 484001
Guadalajara, , Mexico
Investigational Site Number 484006
Mazatlán, , Mexico
Investigational Site Number 554003
Christchurch, , New Zealand
Investigational Site Number 554001
Christchurch, , New Zealand
Investigational Site Number 554002
Nelson South, , New Zealand
Investigational Site Number 578001
Trondheim, , Norway
Investigational Site Number 604003
Callao, , Peru
Investigational Site Number 604004
Callao, , Peru
Investigational Site Number 604006
Lima, , Peru
Investigational Site Number 604001
Lima, , Peru
Investigational Site Number 604005
Lima, , Peru
Investigational Site Number 604002
Lima, , Peru
Investigational Site Number 616001
Bydgoszcz, , Poland
Investigational Site Number 616003
Bydgoszcz, , Poland
Investigational Site Number 616006
Gdansk, , Poland
Investigational Site Number 616005
Krakow, , Poland
Investigational Site Number 616018
Krakow, , Poland
Investigational Site Number 616020
Krakow, , Poland
Investigational Site Number 616009
Lodz, , Poland
Investigational Site Number 616002
Lodz, , Poland
Investigational Site Number 616010
Lublin, , Poland
Investigational Site Number 616012
Poznan, , Poland
Investigational Site Number 616015
Sosnowiec, , Poland
Investigational Site Number 616013
Szczecin, , Poland
Investigational Site Number 616011
Torun, , Poland
Investigational Site Number 616004
Warsaw, , Poland
Investigational Site Number 616014
Warsaw, , Poland
Investigational Site Number 616008
Wroclaw, , Poland
Investigational Site Number 616007
Wroclaw, , Poland
Investigational Site Number 616016
Wroclaw, , Poland
Investigational Site Number 642003
Cluj-Napoca, , Romania
Investigational Site Number 642006
Cluj-Napoca, , Romania
Investigational Site Number 642005
Cluj-Napoca, , Romania
Investigational Site Number 642001
Oradea, , Romania
Investigational Site Number 642004
Oradea, , Romania
Investigational Site Number 642002
Timișoara, , Romania
Investigational Site Number 643019
Krasnodar, , Russia
Investigational Site Number 643006
Krasnoyarsk, , Russia
Investigational Site Number 643003
Moscow, , Russia
Investigational Site Number 643001
Moscow, , Russia
Investigational Site Number 643002
Moscow, , Russia
Investigational Site Number 643020
Moscow, , Russia
Investigational Site Number 643021
Moscow, , Russia
Investigational Site Number 643025
Moscow, , Russia
Investigational Site Number 643008
Novosibirsk, , Russia
Investigational Site Number 643007
Novosibirsk, , Russia
Investigational Site Number 643026
Omsk, , Russia
Investigational Site Number 643011
Saint Petersburg, , Russia
Investigational Site Number 643010
Saint Petersburg, , Russia
Investigational Site Number 643009
Saint Petersburg, , Russia
Investigational Site Number 643018
Saint Petersburg, , Russia
Investigational Site Number 643017
Saint Petersburg, , Russia
Investigational Site Number 643015
Sestroretsk, , Russia
Investigational Site Number 643012
Tomsk, , Russia
Investigational Site Number 643016
Vsevolozhsk, , Russia
Investigational Site Number 643014
Yaroslavl, , Russia
Investigational Site Number 688001
Belgrade, , Serbia
Investigational Site Number 688004
Belgrade, , Serbia
Investigational Site Number 688002
Novi Sad, , Serbia
Investigational Site Number 703001
Bratislava, , Slovakia
Investigational Site Number 705001
Celje, , Slovenia
Investigational Site Number 705002
Maribor, , Slovenia
Investigational Site Number 710001
Cape Town, , South Africa
Investigational Site Number 710004
Cape Town, , South Africa
Investigational Site Number 710003
Worcester, , South Africa
Investigational Site Number 410007
Daegu, , South Korea
Investigational Site Number 410006
Goyang, , South Korea
Investigational Site Number 410001
Gyeonggi-do, , South Korea
Investigational Site Number 410009
Incheon, , South Korea
Investigational Site Number 410011
Seoul, , South Korea
Investigational Site Number 410004
Seoul, , South Korea
Investigational Site Number 410002
Seoul, , South Korea
Investigational Site Number 410010
Seoul, , South Korea
Investigational Site Number 410008
Seoul, , South Korea
Investigational Site Number 410003
Suwon, , South Korea
Investigational Site Number 724001
Barcelona, , Spain
Investigational Site Number 724002
Madrid, , Spain
Investigational Site Number 752002
Kungälv, , Sweden
Investigational Site Number 752004
Norrköping, , Sweden
Investigational Site Number 752001
Stockholm, , Sweden
Investigational Site Number 752003
Varberg, , Sweden
Investigational Site Number 792003
Istanbul, , Turkey (Türkiye)
Investigational Site Number 792001
Istanbul, , Turkey (Türkiye)
Investigational Site Number 792006
Istanbul, , Turkey (Türkiye)
Investigational Site Number 792007
Izmir, , Turkey (Türkiye)
Investigational Site Number 804003
Cherkasy, , Ukraine
Investigational Site Number 804007
Donetsk, , Ukraine
Investigational Site Number 804010
Donetsk, , Ukraine
Investigational Site Number 804011
Kharkiv, , Ukraine
Investigational Site Number 804005
Kyiv, , Ukraine
Investigational Site Number 804002
Kyiv, , Ukraine
Investigational Site Number 804004
Kyiv, , Ukraine
Investigational Site Number 804008
Odesa, , Ukraine
Investigational Site Number 826001
London, , United Kingdom
Countries
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References
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Kakkar AK, Agnelli G, Fisher W, George D, Lassen MR, Mismetti P, Mouret P, Murphy J, Lawson F, Turpie AG; SAVE-ABDO Investigators. Preoperative enoxaparin versus postoperative semuloparin thromboprophylaxis in major abdominal surgery: a randomized controlled trial. Ann Surg. 2014 Jun;259(6):1073-9. doi: 10.1097/SLA.0000000000000430.
Other Identifiers
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2007-007942-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC6520
Identifier Type: -
Identifier Source: org_study_id