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Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery (SAVE-ABDO)

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Semuloparin Sodium
Enoxaparin sodium
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Digestive System Surgical Procedure, Urologic Surgical Procedure, Prevention of venous thromboembolism, Abdominal surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840026
  • Investigational Site Number 840035
  • Investigational Site Number 840042
  • Investigational Site Number 840002
  • Investigational Site Number 840031
  • Investigational Site Number 840007
  • Investigational Site Number 840014
  • Investigational Site Number 840011
  • Investigational Site Number 840021
  • Investigational Site Number 840029
  • Investigational Site Number 840017
  • Investigational Site Number 840044
  • Investigational Site Number 840015
  • Investigational Site Number 840009
  • Investigational Site Number 840019
  • Investigational Site Number 840036
  • Investigational Site Number 840037
  • Investigational Site Number 840008
  • Investigational Site Number 840020
  • Investigational Site Number 840051
  • Investigational Site Number 840006
  • Investigational Site Number 840025
  • Investigational Site Number 840050
  • Investigational Site Number 840032
  • Investigational Site Number 840043
  • Investigational Site Number 032002
  • Investigational Site Number 032001
  • Investigational Site Number 032004
  • Investigational Site Number 032007
  • Investigational Site Number 032008
  • Investigational Site Number 032014
  • Investigational Site Number 032012
  • Investigational Site Number 032005
  • Investigational Site Number 036002
  • Investigational Site Number 036003
  • Investigational Site Number 036001
  • Investigational Site Number 036008
  • Investigational Site Number 040001
  • Investigational Site Number 040002
  • Investigational Site Number 112001
  • Investigational Site Number 112006
  • Investigational Site Number 112003
  • Investigational Site Number 112008
  • Investigational Site Number 112002
  • Investigational Site Number 112005
  • Investigational Site Number 112004
  • Investigational Site Number 112007
  • Investigational Site Number 056002
  • Investigational Site Number 056001
  • Investigational Site Number 076003
  • Investigational Site Number 076010
  • Investigational Site Number 076014
  • Investigational Site Number 076012
  • Investigational Site Number 076005
  • Investigational Site Number 076006
  • Investigational Site Number 076011
  • Investigational Site Number 076007
  • Investigational Site Number 076009
  • Investigational Site Number 076015
  • Investigational Site Number 076013
  • Investigational Site Number 076004
  • Investigational Site Number 076002
  • Investigational Site Number 076008
  • Investigational Site Number 100004
  • Investigational Site Number 100003
  • Investigational Site Number 100011
  • Investigational Site Number 100005
  • Investigational Site Number 100008
  • Investigational Site Number 100009
  • Investigational Site Number 100006
  • Investigational Site Number 100010
  • Investigational Site Number 124001
  • Investigational Site Number 124004
  • Investigational Site Number 124010
  • Investigational Site Number 124011
  • Investigational Site Number 124009
  • Investigational Site Number 124002
  • Investigational Site Number 124007
  • Investigational Site Number 152002
  • Investigational Site Number 152001
  • Investigational Site Number 156011
  • Investigational Site Number 156012
  • Investigational Site Number 156010
  • Investigational Site Number 156006
  • Investigational Site Number 156003
  • Investigational Site Number 156013
  • Investigational Site Number 156005
  • Investigational Site Number 156008
  • Investigational Site Number 156001
  • Investigational Site Number 156014
  • Investigational Site Number 156004
  • Investigational Site Number 191004
  • Investigational Site Number 191001
  • Investigational Site Number 191002
  • Investigational Site Number 203007
  • Investigational Site Number 203001
  • Investigational Site Number 203011
  • Investigational Site Number 203015
  • Investigational Site Number 203009
  • Investigational Site Number 203004
  • Investigational Site Number 203014
  • Investigational Site Number 203003
  • Investigational Site Number 203012
  • Investigational Site Number 203008
  • Investigational Site Number 203006
  • Investigational Site Number 203002
  • Investigational Site Number 203016
  • Investigational Site Number 203010
  • Investigational Site Number 208001
  • Investigational Site Number 208002
  • Investigational Site Number 233003
  • Investigational Site Number 233001
  • Investigational Site Number 233002
  • Investigational Site Number 276011
  • Investigational Site Number 276015
  • Investigational Site Number 276018
  • Investigational Site Number 276006
  • Investigational Site Number 276012
  • Investigational Site Number 276002
  • Investigational Site Number 276004
  • Investigational Site Number 276014
  • Investigational Site Number 276016
  • Investigational Site Number 276013
  • Investigational Site Number 276001
  • Investigational Site Number 300002
  • Investigational Site Number 348007
  • Investigational Site Number 348009
  • Investigational Site Number 348008
  • Investigational Site Number 348004
  • Investigational Site Number 348003
  • Investigational Site Number 356005
  • Investigational Site Number 356004
  • Investigational Site Number 356033
  • Investigational Site Number 356011
  • Investigational Site Number 356027
  • Investigational Site Number 356008
  • Investigational Site Number 356019
  • Investigational Site Number 356031
  • Investigational Site Number 356014
  • Investigational Site Number 356018
  • Investigational Site Number 356016
  • Investigational Site Number 356021
  • Investigational Site Number 356013
  • Investigational Site Number 356006
  • Investigational Site Number 356025
  • Investigational Site Number 356028
  • Investigational Site Number 356010
  • Investigational Site Number 356002
  • Investigational Site Number 356022
  • Investigational Site Number 356007
  • Investigational Site Number 356026
  • Investigational Site Number 356032
  • Investigational Site Number 356003
  • Investigational Site Number 356001
  • Investigational Site Number 356030
  • Investigational Site Number 356009
  • Investigational Site Number 356023
  • Investigational Site Number 356015
  • Investigational Site Number 356012
  • Investigational Site Number 380009
  • Investigational Site Number 380001
  • Investigational Site Number 380015
  • Investigational Site Number 380006
  • Investigational Site Number 380004
  • Investigational Site Number 380008
  • Investigational Site Number 380013
  • Investigational Site Number 380012
  • Investigational Site Number 380005
  • Investigational Site Number 380011
  • Investigational Site Number 380007
  • Investigational Site Number 410007
  • Investigational Site Number 410006
  • Investigational Site Number 410001
  • Investigational Site Number 410009
  • Investigational Site Number 410011
  • Investigational Site Number 410004
  • Investigational Site Number 410002
  • Investigational Site Number 410010
  • Investigational Site Number 410008
  • Investigational Site Number 410003
  • Investigational Site Number 428004
  • Investigational Site Number 428003
  • Investigational Site Number 428002
  • Investigational Site Number 440003
  • Investigational Site Number 440001
  • Investigational Site Number 440002
  • Investigational Site Number 484001
  • Investigational Site Number 484006
  • Investigational Site Number 554003
  • Investigational Site Number 554001
  • Investigational Site Number 554002
  • Investigational Site Number 578001
  • Investigational Site Number 604003
  • Investigational Site Number 604004
  • Investigational Site Number 604006
  • Investigational Site Number 604001
  • Investigational Site Number 604005
  • Investigational Site Number 604002
  • Investigational Site Number 616001
  • Investigational Site Number 616003
  • Investigational Site Number 616006
  • Investigational Site Number 616005
  • Investigational Site Number 616018
  • Investigational Site Number 616020
  • Investigational Site Number 616009
  • Investigational Site Number 616002
  • Investigational Site Number 616010
  • Investigational Site Number 616012
  • Investigational Site Number 616015
  • Investigational Site Number 616013
  • Investigational Site Number 616011
  • Investigational Site Number 616004
  • Investigational Site Number 616014
  • Investigational Site Number 616008
  • Investigational Site Number 616007
  • Investigational Site Number 616016
  • Investigational Site Number 642003
  • Investigational Site Number 642006
  • Investigational Site Number 642005
  • Investigational Site Number 642001
  • Investigational Site Number 642004
  • Investigational Site Number 642002
  • Investigational Site Number 643019
  • Investigational Site Number 643006
  • Investigational Site Number 643003
  • Investigational Site Number 643001
  • Investigational Site Number 643002
  • Investigational Site Number 643020
  • Investigational Site Number 643021
  • Investigational Site Number 643025
  • Investigational Site Number 643008
  • Investigational Site Number 643007
  • Investigational Site Number 643026
  • Investigational Site Number 643015
  • Investigational Site Number 643011
  • Investigational Site Number 643018
  • Investigational Site Number 643017
  • Investigational Site Number 643010
  • Investigational Site Number 643009
  • Investigational Site Number 643012
  • Investigational Site Number 643016
  • Investigational Site Number 643014
  • Investigational Site Number 688001
  • Investigational Site Number 688004
  • Investigational Site Number 688002
  • Investigational Site Number 703001
  • Investigational Site Number 705001
  • Investigational Site Number 705002
  • Investigational Site Number 710001
  • Investigational Site Number 710004
  • Investigational Site Number 710003
  • Investigational Site Number 724001
  • Investigational Site Number 724002
  • Investigational Site Number 752002
  • Investigational Site Number 752004
  • Investigational Site Number 752001
  • Investigational Site Number 752003
  • Investigational Site Number 792003
  • Investigational Site Number 792001
  • Investigational Site Number 792006
  • Investigational Site Number 792007
  • Investigational Site Number 804003
  • Investigational Site Number 804007
  • Investigational Site Number 804010
  • Investigational Site Number 804011
  • Investigational Site Number 804005
  • Investigational Site Number 804002
  • Investigational Site Number 804004
  • Investigational Site Number 804008
  • Investigational Site Number 826001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Semuloparin

Enoxaparin

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death
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
"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 )
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
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.

Full Information

First Posted
May 7, 2008
Last Updated
November 21, 2013
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00679588
Brief Title
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
Acronym
SAVE-ABDO
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Digestive System Surgical Procedure, Urologic Surgical Procedure, Prevention of venous thromboembolism, Abdominal surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4413 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semuloparin
Arm Type
Experimental
Arm Description
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)
Arm Title
Enoxaparin
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Semuloparin Sodium
Other Intervention Name(s)
AVE5026
Intervention Description
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Enoxaparin sodium
Other Intervention Name(s)
Lovenox®
Intervention Description
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death
Description
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.
Time Frame
From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Experience "major" VTE or All-cause Death
Description
"major" VTE includes any proximal DVT, symptomatic distal DVT and non-fatal Pulmonary Embolism (PE) as as confirmed by the CIAC.
Time Frame
From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first
Title
Percentage of Participants Who Experience Clinically Relevant Bleedings ("major" and "clinically relevant non-major" bleedings )
Description
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".
Time Frame
From 1st study drug injection up to 3 days after last study drug injection
Title
Percentage of Participants requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
Description
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.
Time Frame
From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first
Other Pre-specified Outcome Measures:
Title
Number of Deaths on Treatment
Description
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).
Time Frame
From 1st study drug injection up to 3 days after last study drug injection
Title
Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA)
Description
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.
Time Frame
From 1st study drug injection up to 3 days after last study drug injection
Title
Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA)
Description
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.
Time Frame
From 1st study drug injection up to 3 days after last study drug injection
Title
Trough Plasma Concentration of Semuloparin Sodium (AVE5026)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajay Kakkar, Prof., MD, PhD
Organizational Affiliation
Queen Mary's School of Medicine & Dentistry, London (UK)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Turpie, MD
Organizational Affiliation
HHS-General Hospital, Hamilton, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Investigational Site Number 840026
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Investigational Site Number 840035
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Investigational Site Number 840042
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Investigational Site Number 840002
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35234
Country
United States
Facility Name
Investigational Site Number 840031
City
Corlton
State/Province
California
ZIP/Postal Code
82324
Country
United States
Facility Name
Investigational Site Number 840007
City
Huntingdon Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Investigational Site Number 840014
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Investigational Site Number 840011
City
Sant Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Investigational Site Number 840021
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Investigational Site Number 840029
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Investigational Site Number 840017
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Investigational Site Number 840044
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Investigational Site Number 840015
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Investigational Site Number 840009
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Investigational Site Number 840019
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Investigational Site Number 840036
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Investigational Site Number 840037
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Investigational Site Number 840008
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Investigational Site Number 840020
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Investigational Site Number 840051
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Investigational Site Number 840006
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Investigational Site Number 840025
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Investigational Site Number 840050
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Investigational Site Number 840032
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79409
Country
United States
Facility Name
Investigational Site Number 840043
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Investigational Site Number 032002
City
Buenos Aires
ZIP/Postal Code
1155
Country
Argentina
Facility Name
Investigational Site Number 032001
City
Buenos Aires
ZIP/Postal Code
1416
Country
Argentina
Facility Name
Investigational Site Number 032004
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site Number 032007
City
Capital Federal
ZIP/Postal Code
1039
Country
Argentina
Facility Name
Investigational Site Number 032008
City
Capital Federal
ZIP/Postal Code
C1408INH
Country
Argentina
Facility Name
Investigational Site Number 032014
City
Córdoba
ZIP/Postal Code
X5000AAI
Country
Argentina
Facility Name
Investigational Site Number 032012
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Investigational Site Number 032005
City
Santa Fe
ZIP/Postal Code
S3000EPV
Country
Argentina
Facility Name
Investigational Site Number 036002
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Investigational Site Number 036003
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Investigational Site Number 036001
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
Investigational Site Number 036008
City
Redcliffe
ZIP/Postal Code
4020
Country
Australia
Facility Name
Investigational Site Number 040001
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Investigational Site Number 040002
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Investigational Site Number 112001
City
Gomel
ZIP/Postal Code
246012
Country
Belarus
Facility Name
Investigational Site Number 112006
City
Gomel
ZIP/Postal Code
246012
Country
Belarus
Facility Name
Investigational Site Number 112003
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Investigational Site Number 112008
City
Minsk
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Investigational Site Number 112002
City
Minsk
Country
Belarus
Facility Name
Investigational Site Number 112005
City
Minsk
Country
Belarus
Facility Name
Investigational Site Number 112004
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
Facility Name
Investigational Site Number 112007
City
Vitebsk
Country
Belarus
Facility Name
Investigational Site Number 056002
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Investigational Site Number 056001
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Investigational Site Number 076003
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Investigational Site Number 076010
City
Belo Horizonte
ZIP/Postal Code
30380-490
Country
Brazil
Facility Name
Investigational Site Number 076014
City
Caxias Do Sul
ZIP/Postal Code
95001-960
Country
Brazil
Facility Name
Investigational Site Number 076012
City
Curitiba
ZIP/Postal Code
80050-350
Country
Brazil
Facility Name
Investigational Site Number 076005
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Investigational Site Number 076006
City
Goiania
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Investigational Site Number 076011
City
Joinville
ZIP/Postal Code
89202-000
Country
Brazil
Facility Name
Investigational Site Number 076007
City
Porto Alegre
ZIP/Postal Code
90035 003
Country
Brazil
Facility Name
Investigational Site Number 076009
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Investigational Site Number 076015
City
Ribeirao Preto
ZIP/Postal Code
14049-900
Country
Brazil
Facility Name
Investigational Site Number 076013
City
Sao Jose Do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Investigational Site Number 076004
City
Sao Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Facility Name
Investigational Site Number 076002
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Investigational Site Number 076008
City
Sao Paulo
ZIP/Postal Code
08270-070
Country
Brazil
Facility Name
Investigational Site Number 100004
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Investigational Site Number 100003
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Investigational Site Number 100011
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Investigational Site Number 100005
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Investigational Site Number 100008
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Investigational Site Number 100009
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Investigational Site Number 100006
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Investigational Site Number 100010
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Investigational Site Number 124001
City
Edmonton
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Investigational Site Number 124004
City
Kitchener
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
Investigational Site Number 124010
City
Montreal
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Investigational Site Number 124011
City
Red Deer
ZIP/Postal Code
T4N 4E6
Country
Canada
Facility Name
Investigational Site Number 124009
City
Saint John
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Investigational Site Number 124002
City
Thunder Bay
ZIP/Postal Code
P7B 6V1
Country
Canada
Facility Name
Investigational Site Number 124007
City
Vancouver
ZIP/Postal Code
V5Z 4E3
Country
Canada
Facility Name
Investigational Site Number 152002
City
Rancagua
Country
Chile
Facility Name
Investigational Site Number 152001
City
Santiago
ZIP/Postal Code
838-0456
Country
Chile
Facility Name
Investigational Site Number 156011
City
Baotou
ZIP/Postal Code
014010
Country
China
Facility Name
Investigational Site Number 156012
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Investigational Site Number 156010
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Investigational Site Number 156006
City
Fuzhou
ZIP/Postal Code
354200
Country
China
Facility Name
Investigational Site Number 156003
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
Investigational Site Number 156013
City
Haikou
ZIP/Postal Code
570208
Country
China
Facility Name
Investigational Site Number 156005
City
Nanjing
ZIP/Postal Code
210006
Country
China
Facility Name
Investigational Site Number 156008
City
Qingdao
ZIP/Postal Code
266003
Country
China
Facility Name
Investigational Site Number 156001
City
Shijiazhuang
ZIP/Postal Code
050051
Country
China
Facility Name
Investigational Site Number 156014
City
Tianjin
ZIP/Postal Code
300121
Country
China
Facility Name
Investigational Site Number 156004
City
Xi'An
ZIP/Postal Code
710038
Country
China
Facility Name
Investigational Site Number 191004
City
Pozega
ZIP/Postal Code
34000
Country
Croatia
Facility Name
Investigational Site Number 191001
City
Pula
ZIP/Postal Code
52100
Country
Croatia
Facility Name
Investigational Site Number 191002
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Investigational Site Number 203007
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
Investigational Site Number 203001
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
Facility Name
Investigational Site Number 203011
City
Jihlava
ZIP/Postal Code
58633
Country
Czech Republic
Facility Name
Investigational Site Number 203015
City
Kolin
ZIP/Postal Code
28020
Country
Czech Republic
Facility Name
Investigational Site Number 203009
City
Kromeriz
ZIP/Postal Code
76755
Country
Czech Republic
Facility Name
Investigational Site Number 203004
City
Liberec
ZIP/Postal Code
46063
Country
Czech Republic
Facility Name
Investigational Site Number 203014
City
Most
ZIP/Postal Code
43464
Country
Czech Republic
Facility Name
Investigational Site Number 203003
City
Ostrava
ZIP/Postal Code
72880
Country
Czech Republic
Facility Name
Investigational Site Number 203012
City
Pardubice
ZIP/Postal Code
53203
Country
Czech Republic
Facility Name
Investigational Site Number 203008
City
Praha 4
ZIP/Postal Code
14059
Country
Czech Republic
Facility Name
Investigational Site Number 203006
City
Praha 5
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Investigational Site Number 203002
City
Praha 6
ZIP/Postal Code
16902
Country
Czech Republic
Facility Name
Investigational Site Number 203016
City
Ricany
ZIP/Postal Code
25001
Country
Czech Republic
Facility Name
Investigational Site Number 203010
City
Usti Nad Labem
ZIP/Postal Code
40113
Country
Czech Republic
Facility Name
Investigational Site Number 208001
City
København Nv
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Investigational Site Number 208002
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Investigational Site Number 233003
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Investigational Site Number 233001
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Investigational Site Number 233002
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Investigational Site Number 276011
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Investigational Site Number 276015
City
Castrop-Rauxel
ZIP/Postal Code
44575
Country
Germany
Facility Name
Investigational Site Number 276018
City
Castrop-Rauxel
ZIP/Postal Code
44575
Country
Germany
Facility Name
Investigational Site Number 276006
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Investigational Site Number 276012
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Investigational Site Number 276002
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Investigational Site Number 276004
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Investigational Site Number 276014
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Investigational Site Number 276016
City
Magdeburg
ZIP/Postal Code
39130
Country
Germany
Facility Name
Investigational Site Number 276013
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Investigational Site Number 276001
City
Stralsund
ZIP/Postal Code
18435
Country
Germany
Facility Name
Investigational Site Number 300002
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Investigational Site Number 348007
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Investigational Site Number 348009
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Investigational Site Number 348008
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Investigational Site Number 348004
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Investigational Site Number 348003
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Investigational Site Number 356005
City
Ahmedabad
ZIP/Postal Code
380 006
Country
India
Facility Name
Investigational Site Number 356004
City
Ahmedabad
ZIP/Postal Code
380 008
Country
India
Facility Name
Investigational Site Number 356033
City
Andhra Pradesh
Country
India
Facility Name
Investigational Site Number 356011
City
Bangalore
ZIP/Postal Code
560 034
Country
India
Facility Name
Investigational Site Number 356027
City
Bangalore
ZIP/Postal Code
560029
Country
India
Facility Name
Investigational Site Number 356008
City
Bangalore
Country
India
Facility Name
Investigational Site Number 356019
City
Banglore
ZIP/Postal Code
560054
Country
India
Facility Name
Investigational Site Number 356031
City
Bhopal
Country
India
Facility Name
Investigational Site Number 356014
City
Chennai
ZIP/Postal Code
600 096
Country
India
Facility Name
Investigational Site Number 356018
City
Chennai
ZIP/Postal Code
600010
Country
India
Facility Name
Investigational Site Number 356016
City
Chennai
ZIP/Postal Code
600035
Country
India
Facility Name
Investigational Site Number 356021
City
Chennai
ZIP/Postal Code
600101
Country
India
Facility Name
Investigational Site Number 356013
City
Cochin
ZIP/Postal Code
682026
Country
India
Facility Name
Investigational Site Number 356006
City
Coimbatore
ZIP/Postal Code
641037
Country
India
Facility Name
Investigational Site Number 356025
City
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Investigational Site Number 356028
City
Hyderabad
ZIP/Postal Code
500004
Country
India
Facility Name
Investigational Site Number 356010
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Investigational Site Number 356002
City
Jaipur
ZIP/Postal Code
302013
Country
India
Facility Name
Investigational Site Number 356022
City
Jaipur
Country
India
Facility Name
Investigational Site Number 356007
City
Kochi
ZIP/Postal Code
682304
Country
India
Facility Name
Investigational Site Number 356026
City
Lucknow
Country
India
Facility Name
Investigational Site Number 356032
City
Ludhiana
ZIP/Postal Code
141001
Country
India
Facility Name
Investigational Site Number 356003
City
Luknow
ZIP/Postal Code
226014
Country
India
Facility Name
Investigational Site Number 356001
City
Mangalore
Country
India
Facility Name
Investigational Site Number 356030
City
Nagpur
Country
India
Facility Name
Investigational Site Number 356009
City
New Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Investigational Site Number 356023
City
Pune
ZIP/Postal Code
411 011
Country
India
Facility Name
Investigational Site Number 356015
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Investigational Site Number 356012
City
Punjgutta
Country
India
Facility Name
Investigational Site Number 380009
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Investigational Site Number 380001
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Investigational Site Number 380015
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Investigational Site Number 380006
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Investigational Site Number 380004
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Investigational Site Number 380008
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Investigational Site Number 380013
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
Investigational Site Number 380012
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Investigational Site Number 380005
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Investigational Site Number 380011
City
San Donato Milanese
ZIP/Postal Code
20097
Country
Italy
Facility Name
Investigational Site Number 380007
City
Trieste
ZIP/Postal Code
34149
Country
Italy
Facility Name
Investigational Site Number 410007
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Investigational Site Number 410006
City
Goyang
ZIP/Postal Code
410-773
Country
Korea, Republic of
Facility Name
Investigational Site Number 410001
City
Gyeonggi-do
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Investigational Site Number 410009
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Investigational Site Number 410011
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Investigational Site Number 410004
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Investigational Site Number 410002
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Investigational Site Number 410010
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Investigational Site Number 410008
City
Seoul
ZIP/Postal Code
138-878
Country
Korea, Republic of
Facility Name
Investigational Site Number 410003
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Investigational Site Number 428004
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
Investigational Site Number 428003
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Investigational Site Number 428002
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Investigational Site Number 440003
City
Kaunas
ZIP/Postal Code
LT-47144
Country
Lithuania
Facility Name
Investigational Site Number 440001
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Investigational Site Number 440002
City
Vilnius
ZIP/Postal Code
LT-10207
Country
Lithuania
Facility Name
Investigational Site Number 484001
City
Guadalajara
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Investigational Site Number 484006
City
Mazatlán
ZIP/Postal Code
82110
Country
Mexico
Facility Name
Investigational Site Number 554003
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Investigational Site Number 554001
City
Christchurch
ZIP/Postal Code
8014
Country
New Zealand
Facility Name
Investigational Site Number 554002
City
Nelson South
ZIP/Postal Code
7010
Country
New Zealand
Facility Name
Investigational Site Number 578001
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Investigational Site Number 604003
City
Callao
ZIP/Postal Code
Callao 02
Country
Peru
Facility Name
Investigational Site Number 604004
City
Callao
Country
Peru
Facility Name
Investigational Site Number 604006
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Facility Name
Investigational Site Number 604001
City
Lima
ZIP/Postal Code
LIMA 13
Country
Peru
Facility Name
Investigational Site Number 604005
City
Lima
ZIP/Postal Code
LIMA 18
Country
Peru
Facility Name
Investigational Site Number 604002
City
Lima
ZIP/Postal Code
Lima 29
Country
Peru
Facility Name
Investigational Site Number 616001
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Investigational Site Number 616003
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Investigational Site Number 616006
City
Gdansk
Country
Poland
Facility Name
Investigational Site Number 616005
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Investigational Site Number 616018
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Investigational Site Number 616020
City
Krakow
ZIP/Postal Code
31-913
Country
Poland
Facility Name
Investigational Site Number 616009
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Investigational Site Number 616002
City
Lodz
ZIP/Postal Code
90-647
Country
Poland
Facility Name
Investigational Site Number 616010
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Investigational Site Number 616012
City
Poznan
ZIP/Postal Code
60-747
Country
Poland
Facility Name
Investigational Site Number 616015
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Facility Name
Investigational Site Number 616013
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Investigational Site Number 616011
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Investigational Site Number 616004
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Investigational Site Number 616014
City
Warszawa
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Investigational Site Number 616008
City
Wroclaw
ZIP/Postal Code
50 -556
Country
Poland
Facility Name
Investigational Site Number 616007
City
Wroclaw
ZIP/Postal Code
50-326
Country
Poland
Facility Name
Investigational Site Number 616016
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Investigational Site Number 642003
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Investigational Site Number 642006
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Investigational Site Number 642005
City
Cluj-Napoca
ZIP/Postal Code
400132
Country
Romania
Facility Name
Investigational Site Number 642001
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Investigational Site Number 642004
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Investigational Site Number 642002
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Investigational Site Number 643019
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
Investigational Site Number 643006
City
Krasnoyarsk
ZIP/Postal Code
660058
Country
Russian Federation
Facility Name
Investigational Site Number 643003
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Investigational Site Number 643001
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
Investigational Site Number 643002
City
Moscow
ZIP/Postal Code
119048
Country
Russian Federation
Facility Name
Investigational Site Number 643020
City
Moscow
ZIP/Postal Code
119415
Country
Russian Federation
Facility Name
Investigational Site Number 643021
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Investigational Site Number 643025
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Investigational Site Number 643008
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Investigational Site Number 643007
City
Novosibirsk
ZIP/Postal Code
630054
Country
Russian Federation
Facility Name
Investigational Site Number 643026
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Investigational Site Number 643015
City
Sestroretsk,
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Investigational Site Number 643011
City
St-Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Investigational Site Number 643018
City
St-Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Investigational Site Number 643017
City
St-Petersburg
ZIP/Postal Code
199004
Country
Russian Federation
Facility Name
Investigational Site Number 643010
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Investigational Site Number 643009
City
St.-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Investigational Site Number 643012
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Investigational Site Number 643016
City
Vsevolozhsk
ZIP/Postal Code
188640
Country
Russian Federation
Facility Name
Investigational Site Number 643014
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Investigational Site Number 688001
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Investigational Site Number 688004
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Investigational Site Number 688002
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Investigational Site Number 703001
City
Bratislava
ZIP/Postal Code
821 01
Country
Slovakia
Facility Name
Investigational Site Number 705001
City
Celje
ZIP/Postal Code
3000
Country
Slovenia
Facility Name
Investigational Site Number 705002
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
Investigational Site Number 710001
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Investigational Site Number 710004
City
Cape Town
Country
South Africa
Facility Name
Investigational Site Number 710003
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Investigational Site Number 724001
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Investigational Site Number 724002
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Investigational Site Number 752002
City
Kungälv
ZIP/Postal Code
442 83
Country
Sweden
Facility Name
Investigational Site Number 752004
City
Norrköping
ZIP/Postal Code
601 82
Country
Sweden
Facility Name
Investigational Site Number 752001
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Investigational Site Number 752003
City
Varberg
ZIP/Postal Code
432 81
Country
Sweden
Facility Name
Investigational Site Number 792003
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Facility Name
Investigational Site Number 792001
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Investigational Site Number 792006
City
Istanbul
Country
Turkey
Facility Name
Investigational Site Number 792007
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
Facility Name
Investigational Site Number 804003
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Investigational Site Number 804007
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Investigational Site Number 804010
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Investigational Site Number 804011
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Investigational Site Number 804005
City
Kyiv
ZIP/Postal Code
3022
Country
Ukraine
Facility Name
Investigational Site Number 804002
City
Kyiv
Country
Ukraine
Facility Name
Investigational Site Number 804004
City
Kyiv
Country
Ukraine
Facility Name
Investigational Site Number 804008
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Investigational Site Number 826001
City
London
ZIP/Postal Code
SE5 9PJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24374549
Citation
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.
Results Reference
derived

Learn more about this trial

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

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