Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery (SAVE-ABDO)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00679588
First received: May 7, 2008
Last updated: January 4, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The primary objective of the study was to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of AVE5026 with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery.
The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Thromboembolism |
Drug: Semuloparin Sodium (AVE5026) Drug: Enoxaparin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Multinational, Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery |
Resource links provided by NLM:
MedlinePlus related topics:
Deep Vein Thrombosis
Drug Information available for:
Enoxaparin sodium
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Occurence of the composite endpoint of any VTE confirmed by a blinded Central Independent Adjudication Committee (CIAC) and deaths from any cause [ Time Frame: From randomization up to Day 11 or the day of mandatory venography, whichever comes first ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurence of the composite endpoint of any proximal Deep Vein Thrombosis (DVT), symptomatic distal DVT, non-fatal Pulmonary Embolism (PE), and all cause deaths [ Time Frame: From randomization up to Day 11 or the day of mandatory venography, whichever comes first ] [ Designated as safety issue: No ]
- Number of patients with major bleedings and clinically relevant non-major bleedings as confirmed by the CIAC [ Time Frame: Up to a maximum of 42 days ] [ Designated as safety issue: Yes ]
- Number of patients requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment [ Time Frame: Up to a maximum of 42 days ] [ Designated as safety issue: No ]
| Enrollment: | 4413 |
| Study Start Date: | April 2008 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AVE5026
AVE5026, once daily starting 8 hours after surgery. Matching placebo, before surgery according to Enoxaparin local labeling then 12 hours after surgery. AVE5026 dose was reduced in patients with severe renal impairment. |
Drug: Semuloparin Sodium (AVE5026)
Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection |
|
Active Comparator: Enoxaparin
Enoxaparin, 40 mg once daily starting before surgery according to Enoxaparin local labeling then 12 hours after surgery. Matching placebo, 8 hours after surgery. Enoxaparin dose was reduced to 20 mg in patients with severe renal impairment. |
Drug: Enoxaparin
Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection |
Detailed Description:
The total duration of observation per patient was 35 - 42 days from surgery, and included:
- a double-blind treatment period of 7 - 10 days,
- a follow-up period of 28 - 35 days.
A mandatory bilateral venography was to be performed 7 to 11 days after surgery.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients undergoing major surgery of the abdomen and/or the pelvis.
Patients <60 years with one of the following additional risk factors:
- History of venous thromboembolism,
- Obesity,
- Chronic Heart failure,
- Chronic Respiratory Failure,
- Inflammatory Bowel Disease,
- Cancer Surgery.
Exclusion Criteria:
- Any major orthopedic or general surgery in the 3 months prior to study start.
- Clinical signs or symptoms of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) within the last 12 months or known post phlebitic syndrome.
- Any contra-indications to the performance of venography.
- Patients at high risk of bleeding.
- Known hypersensitivity to heparin or Enoxaparin sodium.
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679588
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| Investigational Site Number 840002 | |
| Birmingham, Alabama, United States, 35234 | |
| Investigational Site Number 840026 | |
| Birmingham, Alabama, United States, 35209 | |
| Investigational Site Number 840035 | |
| Birmingham, Alabama, United States, 35209 | |
| Investigational Site Number 840042 | |
| Birmingham, Alabama, United States, 35209 | |
| United States, California | |
| Investigational Site Number 840031 | |
| Corlton, California, United States, 82324 | |
| Investigational Site Number 840007 | |
| Huntingdon Beach, California, United States, 92647 | |
| Investigational Site Number 840014 | |
| Los Angeles, California, United States, 90033 | |
| Investigational Site Number 840011 | |
| Sant Barbara, California, United States, 93105 | |
| United States, Colorado | |
| Investigational Site Number 840021 | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Investigational Site Number 840029 | |
| Clearwater, Florida, United States, 33756 | |
| Investigational Site Number 840017 | |
| Jacksonville, Florida, United States, 32209 | |
| Investigational Site Number 840044 | |
| Miami, Florida, United States, 33136 | |
| Investigational Site Number 840015 | |
| Orlando, Florida, United States, 32804 | |
| United States, Georgia | |
| Investigational Site Number 840009 | |
| Columbus, Georgia, United States, 31904 | |
| United States, Illinois | |
| Investigational Site Number 840019 | |
| Maywood, Illinois, United States, 60153 | |
| Investigational Site Number 840036 | |
| Springfield, Illinois, United States, 62702 | |
| United States, Kentucky | |
| Investigational Site Number 840037 | |
| Hazard, Kentucky, United States, 41701 | |
| United States, Missouri | |
| Investigational Site Number 840008 | |
| St Louis, Missouri, United States, 63104 | |
| United States, New Jersey | |
| Investigational Site Number 840020 | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, Ohio | |
| Investigational Site Number 840051 | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Investigational Site Number 840006 | |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| United States, Texas | |
| Investigational Site Number 840025 | |
| Houston, Texas, United States, 77024 | |
| Investigational Site Number 840050 | |
| Houston, Texas, United States, 77070 | |
| Investigational Site Number 840032 | |
| Lubbock, Texas, United States, 79409 | |
| United States, West Virginia | |
| Investigational Site Number 840043 | |
| Morgantown, West Virginia, United States, 26506 | |
| Argentina | |
| Investigational Site Number 032004 | |
| Buenos Aires, Argentina | |
| Investigational Site Number 032002 | |
| Buenos Aires, Argentina, 1155 | |
| Investigational Site Number 032001 | |
| Buenos Aires, Argentina, 1416 | |
| Investigational Site Number 032007 | |
| Capital Federal, Argentina, 1039 | |
| Investigational Site Number 032008 | |
| Capital Federal, Argentina, C1408INH | |
| Investigational Site Number 032014 | |
| Córdoba, Argentina, X5000AAI | |
| Investigational Site Number 032012 | |
| Rosario, Argentina, 2000 | |
| Investigational Site Number 032005 | |
| Santa Fe, Argentina, S3000EPV | |
| Australia | |
| Investigational Site Number 036002 | |
| Box Hill, Australia, 3128 | |
| Investigational Site Number 036003 | |
| Box Hill, Australia, 3128 | |
| Investigational Site Number 036001 | |
| Kogarah, Australia, 2217 | |
| Investigational Site Number 036008 | |
| Redcliffe, Australia, 4020 | |
| Austria | |
| Investigational Site Number 040001 | |
| Graz, Austria, 8036 | |
| Investigational Site Number 040002 | |
| Wels, Austria, 4600 | |
| Belarus | |
| Investigational Site Number 112001 | |
| Gomel, Belarus, 246012 | |
| Investigational Site Number 112006 | |
| Gomel, Belarus, 246012 | |
| Investigational Site Number 112008 | |
| Minsk, Belarus, 223040 | |
| Investigational Site Number 112002 | |
| Minsk, Belarus | |
| Investigational Site Number 112003 | |
| Minsk, Belarus, 220013 | |
| Investigational Site Number 112005 | |
| Minsk, Belarus | |
| Investigational Site Number 112004 | |
| Vitebsk, Belarus, 210603 | |
| Investigational Site Number 112007 | |
| Vitebsk, Belarus | |
| Belgium | |
| Investigational Site Number 056002 | |
| Genk, Belgium, 3600 | |
| Investigational Site Number 056001 | |
| Gent, Belgium, 9000 | |
| Brazil | |
| Investigational Site Number 076010 | |
| Belo Horizonte, Brazil, 30380-490 | |
| Investigational Site Number 076003 | |
| Belo Horizonte, Brazil, 30150-221 | |
| Investigational Site Number 076014 | |
| Caxias Do Sul, Brazil, 95001-960 | |
| Investigational Site Number 076012 | |
| Curitiba, Brazil, 80050-350 | |
| Investigational Site Number 076005 | |
| Curitiba, Brazil, 81520-060 | |
| Investigational Site Number 076006 | |
| Goiania, Brazil, 74605-070 | |
| Investigational Site Number 076011 | |
| Joinville, Brazil, 89202-000 | |
| Investigational Site Number 076009 | |
| Porto Alegre, Brazil, 90610-000 | |
| Investigational Site Number 076007 | |
| Porto Alegre, Brazil, 90035 003 | |
| Investigational Site Number 076015 | |
| Ribeirao Preto, Brazil, 14049-900 | |
| Investigational Site Number 076013 | |
| Sao Jose Do Rio Preto, Brazil, 15090-000 | |
| Investigational Site Number 076002 | |
| Sao Paulo, Brazil, 05403-000 | |
| Investigational Site Number 076008 | |
| Sao Paulo, Brazil, 08270-070 | |
| Investigational Site Number 076004 | |
| Sao Paulo, Brazil, 01323-001 | |
| Bulgaria | |
| Investigational Site Number 100004 | |
| Pleven, Bulgaria, 5800 | |
| Investigational Site Number 100003 | |
| Ruse, Bulgaria, 7002 | |
| Investigational Site Number 100008 | |
| Sofia, Bulgaria, 1606 | |
| Investigational Site Number 100009 | |
| Sofia, Bulgaria, 1606 | |
| Investigational Site Number 100005 | |
| Sofia, Bulgaria, 1606 | |
| Investigational Site Number 100011 | |
| Sofia, Bulgaria, 1407 | |
| Investigational Site Number 100010 | |
| Varna, Bulgaria, 9010 | |
| Investigational Site Number 100006 | |
| Varna, Bulgaria, 9010 | |
| Canada | |
| Investigational Site Number 124001 | |
| Edmonton, Canada, T6G 2B7 | |
| Investigational Site Number 124004 | |
| Kitchener, Canada, N2G 1G3 | |
| Investigational Site Number 124010 | |
| Montreal, Canada, H3G 1A4 | |
| Investigational Site Number 124011 | |
| Red Deer, Canada, T4N 4E6 | |
| Investigational Site Number 124009 | |
| Saint John, Canada, E2L 4L2 | |
| Investigational Site Number 124002 | |
| Thunder Bay, Canada, P7B 6V1 | |
| Investigational Site Number 124007 | |
| Vancouver, Canada, V5Z 4E3 | |
| Chile | |
| Investigational Site Number 152002 | |
| Rancagua, Chile | |
| Investigational Site Number 152001 | |
| Santiago, Chile, 838-0456 | |
| China | |
| Investigational Site Number 156011 | |
| Baotou, China, 014010 | |
| Investigational Site Number 156010 | |
| Changsha, China, 410013 | |
| Investigational Site Number 156012 | |
| Changsha, China, 410008 | |
| Investigational Site Number 156006 | |
| Fuzhou, China, 354200 | |
| Investigational Site Number 156003 | |
| Guangzhou, China, 510060 | |
| Investigational Site Number 156013 | |
| Haikou, China, 570208 | |
| Investigational Site Number 156005 | |
| Nanjing, China, 210006 | |
| Investigational Site Number 156008 | |
| Qingdao, China, 266003 | |
| Investigational Site Number 156001 | |
| Shijiazhuang, China, 050051 | |
| Investigational Site Number 156014 | |
| Tianjin, China, 300121 | |
| Investigational Site Number 156004 | |
| Xi'An, China, 710038 | |
| Croatia | |
| Investigational Site Number 191004 | |
| Pozega, Croatia, 34000 | |
| Investigational Site Number 191001 | |
| Pula, Croatia, 52100 | |
| Investigational Site Number 191002 | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| Investigational Site Number 203001 | |
| Brno, Czech Republic, 65691 | |
| Investigational Site Number 203007 | |
| Brno, Czech Republic, 62500 | |
| Investigational Site Number 203011 | |
| Jihlava, Czech Republic, 58633 | |
| Investigational Site Number 203015 | |
| Kolin, Czech Republic, 28020 | |
| Investigational Site Number 203009 | |
| Kromeriz, Czech Republic, 76755 | |
| Investigational Site Number 203004 | |
| Liberec, Czech Republic, 46063 | |
| Investigational Site Number 203014 | |
| Most, Czech Republic, 43464 | |
| Investigational Site Number 203003 | |
| Ostrava, Czech Republic, 72880 | |
| Investigational Site Number 203012 | |
| Pardubice, Czech Republic, 53203 | |
| Investigational Site Number 203008 | |
| Praha 4, Czech Republic, 14059 | |
| Investigational Site Number 203006 | |
| Praha 5, Czech Republic, 15006 | |
| Investigational Site Number 203002 | |
| Praha 6, Czech Republic, 16902 | |
| Investigational Site Number 203016 | |
| Ricany, Czech Republic, 25001 | |
| Investigational Site Number 203010 | |
| Usti Nad Labem, Czech Republic, 40113 | |
| Denmark | |
| Investigational Site Number 208001 | |
| København Nv, Denmark, 2400 | |
| Investigational Site Number 208002 | |
| Odense C, Denmark, 5000 | |
| Estonia | |
| Investigational Site Number 233003 | |
| Tallinn, Estonia, 13419 | |
| Investigational Site Number 233001 | |
| Tartu, Estonia, 50406 | |
| Investigational Site Number 233002 | |
| Tartu, Estonia, 50406 | |
| Germany | |
| Investigational Site Number 276011 | |
| Bochum, Germany, 44791 | |
| Investigational Site Number 276018 | |
| Castrop-Rauxel, Germany, 44575 | |
| Investigational Site Number 276015 | |
| Castrop-Rauxel, Germany, 44575 | |
| Investigational Site Number 276006 | |
| Dresden, Germany, 01067 | |
| Investigational Site Number 276012 | |
| Hannover, Germany, 30625 | |
| Investigational Site Number 276002 | |
| Heidelberg, Germany, 69120 | |
| Investigational Site Number 276004 | |
| Homburg, Germany, 66421 | |
| Investigational Site Number 276014 | |
| Lübeck, Germany, 23538 | |
| Investigational Site Number 276016 | |
| Magdeburg, Germany, 39130 | |
| Investigational Site Number 276013 | |
| München, Germany, 81675 | |
| Investigational Site Number 276001 | |
| Stralsund, Germany, 18435 | |
| Greece | |
| Investigational Site Number 300002 | |
| Heraklion, Greece, 71110 | |
| Hungary | |
| Investigational Site Number 348007 | |
| Debrecen, Hungary, 4032 | |
| Investigational Site Number 348009 | |
| Kistarcsa, Hungary, 2143 | |
| Investigational Site Number 348008 | |
| Szeged, Hungary, 6720 | |
| Investigational Site Number 348004 | |
| Szekesfehervar, Hungary, 8000 | |
| Investigational Site Number 348003 | |
| Szolnok, Hungary, 5000 | |
| India | |
| Investigational Site Number 356004 | |
| Ahmedabad, India, 380 008 | |
| Investigational Site Number 356005 | |
| Ahmedabad, India, 380 006 | |
| Investigational Site Number 356033 | |
| Andhra Pradesh, India | |
| Investigational Site Number 356008 | |
| Bangalore, India | |
| Investigational Site Number 356011 | |
| Bangalore, India, 560 034 | |
| Investigational Site Number 356027 | |
| Bangalore, India, 560029 | |
| Investigational Site Number 356019 | |
| Banglore, India, 560054 | |
| Investigational Site Number 356031 | |
| Bhopal, India | |
| Investigational Site Number 356016 | |
| Chennai, India, 600035 | |
| Investigational Site Number 356018 | |
| Chennai, India, 600010 | |
| Investigational Site Number 356021 | |
| Chennai, India, 600101 | |
| Investigational Site Number 356014 | |
| Chennai, India, 600 096 | |
| Investigational Site Number 356013 | |
| Cochin, India, 682026 | |
| Investigational Site Number 356006 | |
| Coimbatore, India, 641037 | |
| Investigational Site Number 356025 | |
| Gujarat, India, 380006 | |
| Investigational Site Number 356028 | |
| Hyderabad, India, 500004 | |
| Investigational Site Number 356010 | |
| Hyderabad, India, 500082 | |
| Investigational Site Number 356022 | |
| Jaipur, India | |
| Investigational Site Number 356002 | |
| Jaipur, India, 302013 | |
| Investigational Site Number 356007 | |
| Kochi, India, 682304 | |
| Investigational Site Number 356026 | |
| Lucknow, India | |
| Investigational Site Number 356032 | |
| Ludhiana, India, 141001 | |
| Investigational Site Number 356003 | |
| Luknow, India, 226014 | |
| Investigational Site Number 356001 | |
| Mangalore, India | |
| Investigational Site Number 356030 | |
| Nagpur, India | |
| Investigational Site Number 356009 | |
| New Delhi, India, 110085 | |
| Investigational Site Number 356023 | |
| Pune, India, 411 011 | |
| Investigational Site Number 356015 | |
| Pune, India, 411001 | |
| Investigational Site Number 356012 | |
| Punjgutta, India | |
| Italy | |
| Investigational Site Number 380009 | |
| Aviano, Italy, 33081 | |
| Investigational Site Number 380001 | |
| Genova, Italy, 16132 | |
| Investigational Site Number 380015 | |
| Genova, Italy, 16132 | |
| Investigational Site Number 380006 | |
| Milano, Italy, 20132 | |
| Investigational Site Number 380004 | |
| Padova, Italy, 35128 | |
| Investigational Site Number 380008 | |
| Parma, Italy, 43100 | |
| Investigational Site Number 380013 | |
| Piacenza, Italy, 29100 | |
| Investigational Site Number 380012 | |
| Pordenone, Italy, 33170 | |
| Investigational Site Number 380005 | |
| Reggio Emilia, Italy, 42100 | |
| Investigational Site Number 380011 | |
| San Donato Milanese, Italy, 20097 | |
| Investigational Site Number 380007 | |
| Trieste, Italy, 34149 | |
| Korea, Republic of | |
| Investigational Site Number 410007 | |
| Daegu, Korea, Republic of, 700-712 | |
| Investigational Site Number 410006 | |
| Goyang, Korea, Republic of, 410-773 | |
| Investigational Site Number 410001 | |
| Gyeonggi-do, Korea, Republic of, 420-767 | |
| Investigational Site Number 410009 | |
| Incheon, Korea, Republic of, 400-711 | |
| Investigational Site Number 410011 | |
| Seoul, Korea, Republic of, 110-744 | |
| Investigational Site Number 410002 | |
| Seoul, Korea, Republic of, 135-710 | |
| Investigational Site Number 410008 | |
| Seoul, Korea, Republic of, 138-878 | |
| Investigational Site Number 410004 | |
| Seoul, Korea, Republic of, 120-752 | |
| Investigational Site Number 410010 | |
| Seoul, Korea, Republic of, 135-720 | |
| Investigational Site Number 410003 | |
| Suwon, Korea, Republic of, 443-721 | |
| Latvia | |
| Investigational Site Number 428004 | |
| Daugavpils, Latvia, LV-5417 | |
| Investigational Site Number 428003 | |
| Riga, Latvia, LV-1002 | |
| Investigational Site Number 428002 | |
| Riga, Latvia, LV-1038 | |
| Lithuania | |
| Investigational Site Number 440003 | |
| Kaunas, Lithuania, LT-47144 | |
| Investigational Site Number 440001 | |
| Kaunas, Lithuania, LT-50009 | |
| Investigational Site Number 440002 | |
| Vilnius, Lithuania, LT-10207 | |
| Mexico | |
| Investigational Site Number 484001 | |
| Guadalajara, Mexico, 44340 | |
| Investigational Site Number 484006 | |
| Mazatlán, Mexico, 82110 | |
| New Zealand | |
| Investigational Site Number 554001 | |
| Christchurch, New Zealand, 8014 | |
| Investigational Site Number 554003 | |
| Christchurch, New Zealand, 8011 | |
| Investigational Site Number 554002 | |
| Nelson South, New Zealand, 7010 | |
| Norway | |
| Investigational Site Number 578001 | |
| Trondheim, Norway, 7006 | |
| Peru | |
| Investigational Site Number 604004 | |
| Callao, Peru | |
| Investigational Site Number 604003 | |
| Callao, Peru, Callao 02 | |
| Investigational Site Number 604005 | |
| Lima, Peru, LIMA 18 | |
| Investigational Site Number 604002 | |
| Lima, Peru, Lima 29 | |
| Investigational Site Number 604006 | |
| Lima, Peru, LIMA 11 | |
| Investigational Site Number 604001 | |
| Lima, Peru, LIMA 13 | |
| Poland | |
| Investigational Site Number 616003 | |
| Bydgoszcz, Poland, 85-168 | |
| Investigational Site Number 616001 | |
| Bydgoszcz, Poland, 85-094 | |
| Investigational Site Number 616006 | |
| Gdansk, Poland | |
| Investigational Site Number 616020 | |
| Krakow, Poland, 31-913 | |
| Investigational Site Number 616018 | |
| Krakow, Poland, 31-826 | |
| Investigational Site Number 616005 | |
| Krakow, Poland, 31-501 | |
| Investigational Site Number 616002 | |
| Lodz, Poland, 90-647 | |
| Investigational Site Number 616009 | |
| Lodz, Poland, 90-153 | |
| Investigational Site Number 616010 | |
| Lublin, Poland, 20-081 | |
| Investigational Site Number 616012 | |
| Poznan, Poland, 60-747 | |
| Investigational Site Number 616015 | |
| Sosnowiec, Poland, 41-200 | |
| Investigational Site Number 616013 | |
| Szczecin, Poland, 70-111 | |
| Investigational Site Number 616011 | |
| Torun, Poland, 87-100 | |
| Investigational Site Number 616004 | |
| Warszawa, Poland, 02-097 | |
| Investigational Site Number 616014 | |
| Warszawa, Poland, 03-242 | |
| Investigational Site Number 616008 | |
| Wroclaw, Poland, 50 -556 | |
| Investigational Site Number 616016 | |
| Wroclaw, Poland, 51-124 | |
| Investigational Site Number 616007 | |
| Wroclaw, Poland, 50-326 | |
| Romania | |
| Investigational Site Number 642005 | |
| Cluj-Napoca, Romania, 400132 | |
| Investigational Site Number 642006 | |
| Cluj-Napoca, Romania, 400015 | |
| Investigational Site Number 642003 | |
| Cluj-Napoca, Romania, 400006 | |
| Investigational Site Number 642001 | |
| Oradea, Romania, 410169 | |
| Investigational Site Number 642004 | |
| Oradea, Romania, 410169 | |
| Investigational Site Number 642002 | |
| Timisoara, Romania, 300736 | |
| Russian Federation | |
| Investigational Site Number 643019 | |
| Krasnodar, Russian Federation, 350086 | |
| Investigational Site Number 643006 | |
| Krasnoyarsk, Russian Federation, 660058 | |
| Investigational Site Number 643003 | |
| Moscow, Russian Federation, 105229 | |
| Investigational Site Number 643020 | |
| Moscow, Russian Federation, 119415 | |
| Investigational Site Number 643021 | |
| Moscow, Russian Federation, 119991 | |
| Investigational Site Number 643025 | |
| Moscow, Russian Federation, 125367 | |
| Investigational Site Number 643001 | |
| Moscow, Russian Federation, 115280 | |
| Investigational Site Number 643002 | |
| Moscow, Russian Federation, 119048 | |
| Investigational Site Number 643008 | |
| Novosibirsk, Russian Federation, 630047 | |
| Investigational Site Number 643007 | |
| Novosibirsk, Russian Federation, 630054 | |
| Investigational Site Number 643026 | |
| Omsk, Russian Federation, 644013 | |
| Investigational Site Number 643015 | |
| Sestroretsk,, Russian Federation, 197706 | |
| Investigational Site Number 643018 | |
| St-Petersburg, Russian Federation, 195067 | |
| Investigational Site Number 643011 | |
| St-Petersburg, Russian Federation, 191104 | |
| Investigational Site Number 643017 | |
| St-Petersburg, Russian Federation, 199004 | |
| Investigational Site Number 643010 | |
| St. Petersburg, Russian Federation, 194291 | |
| Investigational Site Number 643009 | |
| St.-Petersburg, Russian Federation, 194354 | |
| Investigational Site Number 643012 | |
| Tomsk, Russian Federation, 634063 | |
| Investigational Site Number 643016 | |
| Vsevolozhsk, Russian Federation, 188640 | |
| Investigational Site Number 643014 | |
| Yaroslavl, Russian Federation, 150062 | |
| Serbia | |
| Investigational Site Number 688001 | |
| Belgrade, Serbia, 11080 | |
| Investigational Site Number 688004 | |
| Belgrade, Serbia, 11080 | |
| Investigational Site Number 688002 | |
| Novi Sad, Serbia, 21000 | |
| Slovakia | |
| Investigational Site Number 703001 | |
| Bratislava, Slovakia, 821 01 | |
| Slovenia | |
| Investigational Site Number 705001 | |
| Celje, Slovenia, 3000 | |
| Investigational Site Number 705002 | |
| Maribor, Slovenia, 2000 | |
| South Africa | |
| Investigational Site Number 710001 | |
| Cape Town, South Africa, 7130 | |
| Investigational Site Number 710004 | |
| Cape Town, South Africa | |
| Investigational Site Number 710003 | |
| Worcester, South Africa, 6850 | |
| Spain | |
| Investigational Site Number 724001 | |
| Barcelona, Spain, 08907 | |
| Investigational Site Number 724002 | |
| Madrid, Spain, 28007 | |
| Sweden | |
| Investigational Site Number 752002 | |
| Kungälv, Sweden, 442 83 | |
| Investigational Site Number 752004 | |
| Norrköping, Sweden, 601 82 | |
| Investigational Site Number 752001 | |
| Stockholm, Sweden, 14186 | |
| Investigational Site Number 752003 | |
| Varberg, Sweden, 432 81 | |
| Turkey | |
| Investigational Site Number 792001 | |
| Istanbul, Turkey, 34390 | |
| Investigational Site Number 792006 | |
| Istanbul, Turkey | |
| Investigational Site Number 792003 | |
| Istanbul, Turkey, 34147 | |
| Investigational Site Number 792007 | |
| Izmir, Turkey, 35360 | |
| Ukraine | |
| Investigational Site Number 804003 | |
| Cherkasy, Ukraine, 18009 | |
| Investigational Site Number 804007 | |
| Donetsk, Ukraine, 83092 | |
| Investigational Site Number 804010 | |
| Donetsk, Ukraine, 83092 | |
| Investigational Site Number 804011 | |
| Kharkiv, Ukraine, 61037 | |
| Investigational Site Number 804004 | |
| Kyiv, Ukraine | |
| Investigational Site Number 804002 | |
| Kyiv, Ukraine | |
| Investigational Site Number 804005 | |
| Kyiv, Ukraine, 3022 | |
| Investigational Site Number 804008 | |
| Odessa, Ukraine, 65025 | |
| United Kingdom | |
| Investigational Site Number 826001 | |
| London, United Kingdom, SE5 9PJ | |
Sponsors and Collaborators
Sanofi
Investigators
| Principal Investigator: | Ajay Kakkar, Prof., MD, PhD | Queen Mary's School of Medicine & Dentistry, London (UK) |
| Study Chair: | Alexander Turpie, MD | HHS-General Hospital, Hamilton, Canada |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00679588 History of Changes |
| Other Study ID Numbers: | EFC6520, 2007-007942-36 |
| Study First Received: | May 7, 2008 |
| Last Updated: | January 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Digestive System Surgical Procedure Urologic Surgical Procedure Prevention of venous thromboembolism Abdominal surgery |
Additional relevant MeSH terms:
|
Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Enoxaparin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013