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:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00679588
First received: May 7, 2008
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (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 are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.


Condition Intervention Phase
Venous Thromboembolism
Drug: Semuloparin Sodium
Drug: Enoxaparin sodium
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:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death [ Time Frame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first ] [ Designated as safety issue: No ]

    VTE includes any proximal or distal Deep Vein Thrombosis (DVT) (symptomatic or not) and non-fatal Pulmonary Embolism (PE) as confirmed by a Central Independent Adjudication Committee (CIAC) after review of mandatory bilateral venograms and diagnostic tests for VTE.

    All-cause deaths includes fatal PE and deaths for other reason than PE.



Secondary Outcome Measures:
  • Percentage of Participants Who Experience "major" VTE or All-cause Death [ Time Frame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first ] [ Designated as safety issue: No ]
    "major" VTE includes any proximal DVT, symptomatic distal DVT and non-fatal Pulmonary Embolism (PE) as as confirmed by the CIAC.

  • Percentage of Participants Who Experience Clinically Relevant Bleedings ("major" and "clinically relevant non-major" bleedings ) [ Time Frame: From 1st study drug injection up to 3 days after last study drug injection ] [ Designated as safety issue: Yes ]

    Bleedings are centrally and blindly reviewed by the CIAC and classified as:

    • "major" (fatal, in a critical area/organ, causing a post-operative drop in hemoglobin ≥2 g/dL or requiring post-operative transfusion ≥2 units of blood, leading to an invasive diagnostic or therapeutic intervention, or associated with circulatory decompensation);
    • "clinically relevant non-major" (skin hematoma or epistaxis requiring surgical/medical intervention/treatment, macroscopic hematuria, or overt bleeding requiring specific attention by health care professional);
    • "Nonclinically relevant bleeding".

  • Percentage of Participants requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment [ Time Frame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first ] [ Designated as safety issue: No ]
    Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigator's answer to the question "was the subject treated for VTE?" asked after the diagnostic tests for suspected VTE and after the mandatory venography.


Other Outcome Measures:
  • Number of Deaths on Treatment [ Time Frame: From 1st study drug injection up to 3 days after last study drug injection ] [ Designated as safety issue: Yes ]
    All deaths are centrally and blindly reviewed by the CIAC and classified as fatal PE, fatal bleeding, cardiovascular death or other based on relevant documentation (e.g. autopsy report).

  • Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA) [ Time Frame: From 1st study drug injection up to 3 days after last study drug injection ] [ Designated as safety issue: Yes ]

    PCSA are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.

    Thresholds for platelet counts are defined as <100 Giga/L.


  • Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA) [ Time Frame: From 1st study drug injection up to 3 days after last study drug injection ] [ Designated as safety issue: Yes ]

    Thresholds are defined as follows:

    • Alanine Aminotransferase (ALT) >3 Upper Normal Limit (ULN);
    • Total Bilirubin (TB) >2 ULN;
    • ALT >3 ULN and TB >2 ULN;

    Cases with ALT >3 ULN and TB >2 ULN (not necessarily concomitant) are evaluated by a blinded independent adjudicator to determine if they met Hy's law criteria.


  • Trough Plasma Concentration of Semuloparin Sodium (AVE5026) [ Time Frame: 0.5-1 and 2-4 hours after Day 1 first post-operative injection, 6-8 and 10-16 hours after Day 4 injection, and just before the last injection ] [ Designated as safety issue: No ]

    Trough Plasma Concentration [Ctrough] is defined as plasma concentrations obtained just before study drug injection (i.e.24h±2h after study drug injection).

    Lower Limit Of Quantification (LLOQ) is defined as 0,348 μgEq/mL. Concentrations below LLOQ are replaced by half of LLOQ for the calculation.



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: 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)
Drug: Semuloparin Sodium

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection

Other Name: AVE5026
Drug: 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

Active Comparator: 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)
Drug: Enoxaparin sodium

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection

Other Name: Lovenox®
Drug: 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


Detailed Description:

Randomization has to take place prior to the surgery.

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.

  Eligibility

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

Inclusion Criteria:

  • Patient undergoing major abdominal surgery (open surgery under general anesthesia lasting more than 45 minutes in the peritoneal and/or retroperitoneal space and/or pelvis).
  • 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:

  • Any major orthopedic or general surgery in the 3 months prior to study start;
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679588

  Hide Study Locations
Locations
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 by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: November 21, 2013
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 September 14, 2014