search
Back to results

Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

Primary Purpose

Venous Thromboembolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
edoxaban tosylate(DU-176b)
low molecular weight heparin/unfractionated heparin
warfarin
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism focused on measuring Recurrent Thrombosis, Recurrent Pulmonary Embolism, Symptomatic Deep Vein Thrombosis, Symptomatic Pulmonary Embolism, Venous Thromboembolism (VTE)

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female subjects older than the minimum legal adult age (country specific);
  • Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
  • Able to provide written informed consent

Exclusion Criteria:

  • thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE;
  • More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
  • Calculated Creatinine clearance (CrCL) < 30 mL/min;
  • significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) >\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
  • patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
  • active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
  • chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
  • treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
  • concurrent treatment with potent P-gp inhibitors;
  • subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study

Sites / Locations

  • Investigational Site 7103
  • Investigational Site 7132
  • Investigational Site 7126
  • Investigational Site 7139
  • Investigational Site 1070
  • Investigational Site 7125
  • Investigational Site 1093
  • Investigational Site 1069
  • Investigational Site 7150
  • Investigational Site 1089
  • Investigational Site 1012
  • Investigational Site 1013
  • Investigational Site 1017
  • Investigational Site 1018
  • Investigational Site 1019
  • Investigational Site 1022
  • Investigational Site 1023
  • Investigational Site 1071
  • Investigational Site 7117
  • Investigational Site 7106
  • Investigational Site 1005
  • Investigational Site 1006
  • Investigational Site 7127
  • Investigational Site 7144
  • Investigational Site 1007
  • Investigational Site 7104
  • Investigational Site 1095
  • Investigational Site 1080
  • Investigational Site 7146
  • Investigational Site 1098
  • Investigational Site 7115
  • Investigational Site 1065
  • Investigational Site 1068
  • Investigational Site 1037
  • Investigational Site 1038
  • Investigational Site 7133
  • Investigational Site 7147
  • Investigational Site 1039
  • Investigational Site 7143
  • Investigational Site 7135
  • Investigational Site 7145
  • Investigational Site 7138
  • Investigational Site 7122
  • Investigational Site 7152
  • Investigational Site 1004
  • Investigational Site 7109
  • Investigational Site 1049
  • Investigational Site 7109
  • Investigational Site 7154
  • Investigational Site 7128
  • Investigational Site 1031
  • Investigational Site 1032
  • Investigational Site 1034
  • Investigational Site 1033
  • Investigational Site 1035
  • Investigational Site 1036
  • Investigational Site 1009
  • Investigational Site 1050
  • Investigational Site 1047
  • Investigational Site 7105
  • Investigational Site 1048
  • Investigational Site 1059
  • Investigational Site 1040
  • Investigational Site 1041
  • Investigational Site 1002
  • Investigational Site 1058
  • Investigational Site 1042
  • Investigational Site 1008
  • Investigational Site 7123
  • Investigational Site 1003
  • Investigational Site 1025
  • Investigational Site 1024
  • Investigational Site 1066
  • Investigational Site 1030
  • Investigational Site 7120
  • Investigational Site 1076
  • Investigational Site 1053
  • Investigational Site 1056
  • Investigational Site 1057
  • Investigational Site 1100
  • Investigational Site 1103
  • Investigational Site 1106
  • Investigational Site 1108
  • Investigational Site 1104
  • Investigational Site 1110
  • Investigational Site 1109
  • Investigational Site 4205
  • Investigational Site 4209
  • Investigational Site 4210
  • Investigational Site 4211
  • Investigational Site 4213
  • Investigational Site 4207
  • Investigational Site 4203
  • Investigational Site 4206
  • Investigational Site 4214
  • Investigational Site 4212
  • Investigational Site 4200
  • Investigational Site 2802
  • Investigational Site 2803
  • Investigational Site 2800
  • Investigational Site 2804
  • Investigational Site 2703
  • Investigational Site 2704
  • Investigational Site 2700
  • Investigational site 2701
  • Investigational Site 2702
  • Investigational Site 2705
  • Investigational Site 1608
  • Investigational Site 1602
  • Investigational Site 2905
  • Investigational Site 2914
  • Investigational Site 2901
  • Investigational Site 2903
  • Investigational Site 2912
  • Investigational Site 2915
  • Investigational Site 2917
  • Investigational Site 2904
  • Investigational Site 2900
  • Investigational Site 2902
  • Investigational Site 2906
  • Investigational Site 2910
  • Investigational Site 2911
  • Investigational Site 2006
  • Investigational Site 2001
  • Investigational Site 2007
  • Investigational Site 2000
  • Investigational Site 2003
  • Investigational Site 2005
  • Investigational Site 2004
  • Investigational Site 1200
  • Investigational Site 1204
  • Investigational Site 4301
  • Investigational Site 4302
  • Investigational Site 4306
  • Investigational Site 4321
  • Investigational Site 4327
  • Investigational Site 4337
  • Investigational Site 4316
  • Investigational Site 4310
  • Investigational Site 4325
  • Investigational Site 4317
  • Investigational Site 4328
  • Investigational Site 4319
  • Investigational Site 4313
  • Investigational Site 4303
  • Investigational Site 4324
  • Investigational Site 4330
  • Investigational Site 4335
  • Investigational Site 4326
  • Investigational Site 4308
  • Investigational Site 4318
  • Investigational Site 4320
  • Investigational site 4338
  • Investigational Site 4315
  • Investigational Site 1902
  • Investigational Site 1908
  • Investigational Site 1905
  • Investigational Site 1901
  • Investigational Site 1910
  • Investigational Site 1904
  • Investigational Site 6010
  • Investigational Site 6003
  • Investigational Site 6001
  • Investigational Site 2100
  • Investigational Site 2101
  • Investigational Site 2102
  • Investigational Site 3314
  • Investigational Site 3302
  • Investigational Site 3311
  • Investigational Site 3321
  • Investigational Site 3300
  • Investigational Site 3301
  • Investigational Site 3329
  • Investigational Site 3310
  • Investigational Site 3333
  • Investigational Site 3327
  • Investigational Site 3323
  • Investigational Site 3307
  • Investigational Site 3322
  • Investigational Site 3325
  • Investigational Site 3328
  • Investigational Site 3339
  • Investigational Site 3318
  • Investigational Site 3303
  • Investigational Site 3319
  • Investigational Site 3308
  • Investigational Site 3312
  • Investigational Site 3313
  • Investigational Site 3337
  • Investigational Site 3335
  • Investigational Site 3341
  • Investigational Site 3336
  • Investigational Site 3305
  • Investigational Site 3316
  • Investigational Site 1718
  • Investigational Site 1720
  • Investigational Site 1715
  • Investigational Site 1700
  • Investigational Site 1719
  • Investigational Site 1701
  • Investigational Site 1707
  • Investigational Site 1721
  • Investigational Site 1712
  • Investigational Site 1704
  • Investigational Site 1714
  • Investigational Site 1711
  • Investigational Site 1706
  • Investigational Site 1708
  • Investigational Site 5413
  • Investigational Site 5401
  • Investigational Site 5404
  • Investigational Site 5409
  • Investigational Site 5414
  • Investigational Site 5400
  • Investigational Site 5402
  • Investigational Site 5405
  • Investigational Site 5407
  • Investigational Site 5410
  • Investigational Site 5403
  • Investigational Site 5408
  • Investigational Site 5412
  • Investigational Site 4402
  • Investigational Site 4405
  • Investigational Site 4442
  • Investigational Site 4459
  • Investigational Site 4460
  • Investigational Site 4472
  • Investigational Site 5514
  • Investigational Site 4407
  • Investigational Site 4430
  • Investigational Site 4444
  • Investigational Site 4451
  • Investigational Site 4420
  • Investigational Site 4409
  • Investigational Site 4424
  • Investigational Site 4419
  • Investigational Site 4428
  • Investigational Site 4441
  • Investigational Site 4425
  • Investigational Site 4438
  • Investigational Site 4443
  • Investigational Site 4462
  • Investigational Site 4470
  • Investigational Site 5506
  • Investigational Site 5508
  • Investigational Site 5500
  • Investigational Site 5501
  • Investigational Site 5505
  • Investigational Site 5513
  • Investigational Site 5510
  • Investigational Site 5512
  • Investigational Site 5503
  • Investigational Site 5509
  • Investigational Site 3508
  • Investigational Site 3506
  • Investigational Site 3500
  • Investigational Site 3504
  • Investigational Site 3502
  • Investigational Site 3507
  • Investigational Site 3501
  • Investigational Site 3505
  • Investigational Site 3510
  • Investigational Site 3503
  • Investigational Site 3509
  • Investigational Site 6137
  • Investigational Site 6104
  • Investigational Site 6117
  • Investigational Site 6119
  • Investigational Site 6110
  • Investigational Site 6150
  • Investigational Site 6138
  • Investigational Site 6141
  • Investigational Site 6133
  • Investigational Site 6114
  • Investigational Site 6144
  • Investigational Site 6112
  • Investigational Site 6123
  • Investigational Site 6147
  • Investigational Site 6148
  • Investigational Site 6129
  • Investigational Site 6146
  • Investigational Site 6139
  • Investigational Site 6107
  • Investigational Site 6152
  • Investigational Site 6135
  • Investigational Site 6132
  • Investigational Site 6130
  • Investigational Site 6143
  • Investigational Site 6102
  • Investigational Site 6105
  • Investigational Site 6113
  • Investigational Site 6142
  • Investigational Site 6145
  • Investigational Site 6149
  • Investigational Site 4513
  • Investigational Site 4509
  • Investigational Site 4501
  • Investigational Site 4506
  • Investigational Site 4507
  • Investigational Site 4508
  • Investigational Site 4515
  • Investigational Site 1303
  • Investigational Site 1302
  • Investigational Site 1311
  • Investigational Site 1304
  • Investigational Site 1312
  • Investigational Site 1300
  • Investigational Site 1305
  • Investigational Site 1308
  • Investigational Site 1301
  • Investigational Site 3608
  • Investigational Site 3607
  • Investigational Site 3617
  • Investigational Site 3611
  • Investigational Site 3609
  • Investigational Site 3603
  • Investigational Site 3612
  • Investigational Site 3613
  • Investigational Site 3602
  • Investigational Site 3615
  • Investigational Site 4702
  • Investigational Site 4703
  • Investigational Site 4700
  • Investigational Site 4704
  • Investigational Site 3701
  • Investigational Site 3700
  • Investigational Site 4800
  • Investigational site 4801
  • Investigational Site 4802
  • Investigational Site 5015
  • Investigational Site 5005
  • Investigational Site 5019
  • Investigational Site 5018
  • Investigational Site 5003
  • Investigational Site 5007
  • Investigational Site 5008
  • Investigational Site 5014
  • Investigational Site 3023
  • Investigational Site 3017
  • Investigational Site 3019
  • Investigational Site 3020
  • Investigational Site 3030
  • Investigational Site 3029
  • Investigational Site 3028
  • Investigational Site 3009
  • Investigational Site 3022
  • Investigational Site 3024
  • Investigational Site 3000
  • Investigational Site 3003
  • Investigational Site 3027
  • Investigational Site 3025
  • Investigational Site 3016
  • Investigational Site 3004
  • Investigational Site 3010
  • Investigational Site 5900
  • Investigational Site 5902
  • Investigational Site 4912
  • Investigational Site 4907
  • Investigational Site 4901
  • Investigational Site 4905
  • Investigational Site 4909
  • Investigational Site 4910
  • Investigational Site 4908
  • Investigational Site 4903
  • Investigational Site 4906
  • Investigational Site 4904
  • Investigational Site 4900
  • Investigational site 1503
  • Investigational Site 1502
  • Investigational Site 3900
  • Investigational Site 3904
  • Investigational Site 3903
  • Investigational Site 3905
  • Investigational Site 3902
  • Investigational Site 4103
  • Investigational Site 4110
  • Investigational Site 4104
  • Investigational Site 4102
  • Investigational Site 4109
  • Investigational Site 4100
  • Investigational Site 5104
  • Investigational Site 5105
  • Investigational Site 5101
  • Investigational Site 5103
  • Investigational Site 5200
  • Investigational Site 5202
  • Investigational Site 5203
  • Investigational Site 5702
  • Investigational Site 5703
  • Investigational Site 5702
  • Investigational Site 5706
  • Investigational Site 4008
  • Investigational Site 4010
  • Investigational Site 4000
  • Investigational Site 4002
  • Investigational Site 4001
  • Investigational Site 4007
  • Investigational Site 4009
  • Investigational Site 4003
  • Investigational Site 4006
  • Investigational Site 7005
  • Investigational Site 7006
  • Investigational Site 7000
  • Investigational Site 7003
  • Investigational Site 7004
  • Investigational Site 7001
  • Investigational Site 7007

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

heparin/edoxaban tosylate

heparin/warfarin

Arm Description

Outcomes

Primary Outcome Measures

Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE
Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period. Overall Study Period defined as "The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."

Secondary Outcome Measures

The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality
Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment
Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period.

Full Information

First Posted
September 25, 2009
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00986154
Brief Title
Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).
Official Title
A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Thromboembolism, Venous Thrombosis
Keywords
Recurrent Thrombosis, Recurrent Pulmonary Embolism, Symptomatic Deep Vein Thrombosis, Symptomatic Pulmonary Embolism, Venous Thromboembolism (VTE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
heparin/edoxaban tosylate
Arm Type
Experimental
Arm Title
heparin/warfarin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
edoxaban tosylate(DU-176b)
Intervention Description
edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
Intervention Type
Drug
Intervention Name(s)
low molecular weight heparin/unfractionated heparin
Intervention Description
LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily. Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
Intervention Type
Drug
Intervention Name(s)
warfarin
Intervention Description
tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
Primary Outcome Measure Information:
Title
Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE
Description
Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period. Overall Study Period defined as "The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."
Time Frame
12 months from time of randomization
Secondary Outcome Measure Information:
Title
The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality
Time Frame
12 months from time of randomization
Title
Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment
Description
Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period.
Time Frame
12 months from time of randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects older than the minimum legal adult age (country specific); Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging; Able to provide written informed consent Exclusion Criteria: thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE; More than 48 hours pre-treatment with anticoagulant therapy prior to randomization; Calculated Creatinine clearance (CrCL) < 30 mL/min; significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) >\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN; patients with active cancer for whom long term treatment with (LMW) heparin is anticipated; active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin; chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs); treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy; concurrent treatment with potent P-gp inhibitors; subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
Facility Information:
Facility Name
Investigational Site 7103
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Investigational Site 7132
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
Investigational Site 7126
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Investigational Site 7139
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site 1070
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Investigational Site 7125
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Investigational Site 1093
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Investigational Site 1069
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Investigational Site 7150
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Investigational Site 1089
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Investigational Site 1012
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Investigational Site 1013
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Investigational Site 1017
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Investigational Site 1018
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Investigational Site 1019
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120-4413
Country
United States
Facility Name
Investigational Site 1022
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Facility Name
Investigational Site 1023
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
City
Brandon
State/Province
Florida
Country
United States
Facility Name
Investigational Site 1071
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Investigational Site 7117
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Investigational Site 7106
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Investigational Site 1005
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Investigational Site 1006
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigational Site 7127
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Investigational Site 7144
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Investigational Site 1007
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Investigational Site 7104
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Facility Name
Investigational Site 1095
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Investigational Site 1080
City
Jonesboro
State/Province
Georgia
ZIP/Postal Code
30236
Country
United States
Facility Name
Investigational Site 7146
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31419
Country
United States
Facility Name
Investigational Site 1098
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
City
Carmel
State/Province
Indiana
Country
United States
Facility Name
Investigational Site 7115
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Investigational Site 1065
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Investigational Site 1068
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Investigational Site 1037
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
Facility Name
Investigational Site 1038
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
Facility Name
Investigational Site 7133
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Investigational Site 7147
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Investigational Site 1039
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Investigational Site 7143
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Investigational Site 7135
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Investigational Site 7145
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Investigational Site 7138
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Investigational Site 7122
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Investigational Site 7152
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Investigational Site 1004
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Investigational Site 7109
City
Ephrata
State/Province
Pennsylvania
ZIP/Postal Code
17522
Country
United States
Facility Name
Investigational Site 1049
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Investigational Site 7109
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
Investigational Site 7154
City
Sellersville
State/Province
Pennsylvania
Country
United States
Facility Name
Investigational Site 7128
City
Uniontown
State/Province
Pennsylvania
Country
United States
Facility Name
Investigational Site 1031
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Investigational Site 1032
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Investigational Site 1034
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Investigational Site 1033
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Investigational Site 1035
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
Investigational Site 1036
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Investigational Site 1009
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014-2084
Country
United States
Facility Name
Investigational Site 1050
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Investigational Site 1047
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Investigational Site 7105
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76109
Country
United States
Facility Name
Investigational Site 1048
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Investigational Site 1059
City
Midland
State/Province
Texas
Country
United States
Facility Name
Investigational Site 1040
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Investigational Site 1041
City
Odessa
State/Province
Texas
Country
United States
Facility Name
Investigational Site 1002
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site 1058
City
Sugar Land
State/Province
Texas
Country
United States
Facility Name
Investigational Site 1042
City
Tyler
State/Province
Texas
Country
United States
Facility Name
Investigational Site 1008
City
Waco
State/Province
Texas
Country
United States
Facility Name
Investigational Site 7123
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Investigational Site 1003
City
Fredericksburg
State/Province
Virginia
Country
United States
Facility Name
Investigational Site 1025
City
Newport News
State/Province
Virginia
Country
United States
Facility Name
Investigational Site 1024
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Investigational Site 1066
City
Randallstown
State/Province
Virginia
Country
United States
Facility Name
Investigational Site 1030
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Investigational Site 7120
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Investigational Site 1076
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Investigational Site 1053
City
Vancouver
State/Province
Washington
Country
United States
Facility Name
Investigational Site 1056
City
Vancouver
State/Province
Washington
Country
United States
Facility Name
Investigational Site 1057
City
Vancouver
State/Province
Washington
Country
United States
Facility Name
Investigational Site 1100
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site 1103
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site 1106
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site 1108
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site 1104
City
Cordoba
Country
Argentina
Facility Name
Investigational Site 1110
City
Pcia De Corrientes
Country
Argentina
Facility Name
Investigational Site 1109
City
Santa Fe
Country
Argentina
Facility Name
Investigational Site 4205
City
Bedford Park
Country
Australia
Facility Name
Investigational Site 4209
City
Box Hill
Country
Australia
Facility Name
Investigational Site 4210
City
Clayton
Country
Australia
Facility Name
Investigational Site 4211
City
Fremantle
Country
Australia
Facility Name
Investigational Site 4213
City
Garran
Country
Australia
City
Kogarah
Country
Australia
Facility Name
Investigational Site 4207
City
Perth
Country
Australia
Facility Name
Investigational Site 4203
City
Redcliffe
Country
Australia
Facility Name
Investigational Site 4206
City
Saint Leonards NSW
Country
Australia
Facility Name
Investigational Site 4214
City
South Brisbane
Country
Australia
Facility Name
Investigational Site 4212
City
Westmead NSW
Country
Australia
Facility Name
Investigational Site 4200
City
Windsor
Country
Australia
Facility Name
Investigational Site 2802
City
Feldkirch
Country
Austria
Facility Name
Investigational Site 2803
City
Graz
Country
Austria
Facility Name
Investigational Site 2800
City
Innsbruck
Country
Austria
Facility Name
Investigational Site 2804
City
Linz
Country
Austria
City
Sr. M. Restitutagasse
Country
Austria
City
Vienna
Country
Austria
Facility Name
Investigational Site 2703
City
Gomel
Country
Belarus
Facility Name
Investigational Site 2704
City
Grodno
Country
Belarus
Facility Name
Investigational Site 2700
City
Minsk
Country
Belarus
Facility Name
Investigational site 2701
City
Minsk
Country
Belarus
Facility Name
Investigational Site 2702
City
Minsk
Country
Belarus
Facility Name
Investigational Site 2705
City
Mogilev
Country
Belarus
Facility Name
Investigational Site 1608
City
Aalst
Country
Belgium
Facility Name
Investigational Site 1602
City
Lier
Country
Belgium
Facility Name
Investigational Site 2905
City
Belo Horizonte
Country
Brazil
Facility Name
Investigational Site 2914
City
Campinas
Country
Brazil
Facility Name
Investigational Site 2901
City
Curitiba
Country
Brazil
Facility Name
Investigational Site 2903
City
Curitiba
Country
Brazil
Facility Name
Investigational Site 2912
City
Porto Alegre
Country
Brazil
Facility Name
Investigational Site 2915
City
Porto Alegre
Country
Brazil
Facility Name
Investigational Site 2917
City
Porto Alegre
Country
Brazil
Facility Name
Investigational Site 2904
City
Sao Bernardo do Campo
Country
Brazil
Facility Name
Investigational Site 2900
City
Sao Paulo
Country
Brazil
Facility Name
Investigational Site 2902
City
Sao Paulo
Country
Brazil
Facility Name
Investigational Site 2906
City
Sao Paulo
Country
Brazil
Facility Name
Investigational Site 2910
City
Sao Paulo
Country
Brazil
Facility Name
Investigational Site 2911
City
Sao Paulo
Country
Brazil
Facility Name
Investigational Site 2006
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Investigational Site 2001
City
London
State/Province
Ontario
Country
Canada
Facility Name
Investigational Site 2007
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Investigational Site 2000
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Investigational Site 2003
City
Richmond Hill
State/Province
Ontario
Country
Canada
Facility Name
Investigational Site 2005
City
Halifax
Country
Canada
Facility Name
Investigational Site 2004
City
Montreal
Country
Canada
Facility Name
Investigational Site 1200
City
Santiago
Country
Chile
Facility Name
Investigational Site 1204
City
Santiago
Country
Chile
Facility Name
Investigational Site 4301
City
Beijing
Country
China
Facility Name
Investigational Site 4302
City
Beijing
Country
China
Facility Name
Investigational Site 4306
City
Beijing
Country
China
Facility Name
Investigational Site 4321
City
Beijing
Country
China
Facility Name
Investigational Site 4327
City
Beijing
Country
China
Facility Name
Investigational Site 4337
City
Beijing
Country
China
Facility Name
Investigational Site 4316
City
Guangzhou
Country
China
Facility Name
Investigational Site 4310
City
Hangzhou
Country
China
City
Hebei Province
Country
China
Facility Name
Investigational Site 4325
City
Jiangsu
Country
China
Facility Name
Investigational Site 4317
City
Kunming
Country
China
Facility Name
Investigational Site 4328
City
Nanjing
Country
China
Facility Name
Investigational Site 4319
City
Nanning
Country
China
Facility Name
Investigational Site 4313
City
Qingdao
Country
China
Facility Name
Investigational Site 4303
City
Shanghai
Country
China
Facility Name
Investigational Site 4324
City
Shanghai
Country
China
Facility Name
Investigational Site 4330
City
Shanghai
Country
China
Facility Name
Investigational Site 4335
City
Shanghai
Country
China
Facility Name
Investigational Site 4326
City
Shenyang
Country
China
Facility Name
Investigational Site 4308
City
Sichuan Province
Country
China
Facility Name
Investigational Site 4318
City
Taiyuan
Country
China
Facility Name
Investigational Site 4320
City
Tianjin
Country
China
Facility Name
Investigational site 4338
City
Xi'an
Country
China
Facility Name
Investigational Site 4315
City
Yinchuan
Country
China
City
Chodov
Country
Czechia
City
Jihlava
Country
Czechia
Facility Name
Investigational Site 1902
City
Liberec
Country
Czechia
Facility Name
Investigational Site 1908
City
Olomouc
Country
Czechia
Facility Name
Investigational Site 1905
City
Ostrava
Country
Czechia
Facility Name
Investigational Site 1901
City
Plzen
Country
Czechia
Facility Name
Investigational Site 1910
City
Plzen
Country
Czechia
Facility Name
Investigational Site 1904
City
Praha
Country
Czechia
City
Usti Nad Labem
Country
Czechia
Facility Name
Investigational Site 6010
City
Aarhus
Country
Denmark
City
Arhus N.
Country
Denmark
City
Copenhagen
Country
Denmark
Facility Name
Investigational Site 6003
City
Herlev
Country
Denmark
City
Ringvej
Country
Denmark
Facility Name
Investigational Site 6001
City
Svendborg
Country
Denmark
Facility Name
Investigational Site 2100
City
Tallinn
Country
Estonia
Facility Name
Investigational Site 2101
City
Tallinn
Country
Estonia
Facility Name
Investigational Site 2102
City
Tartu
Country
Estonia
Facility Name
Investigational Site 3314
City
Agen
Country
France
Facility Name
Investigational Site 3302
City
Amiens
Country
France
Facility Name
Investigational Site 3311
City
Angers
Country
France
Facility Name
Investigational Site 3321
City
Annecy
Country
France
Facility Name
Investigational Site 3300
City
Arras
Country
France
Facility Name
Investigational Site 3301
City
Besancon Cedex
Country
France
Facility Name
Investigational Site 3329
City
Bordeaux
Country
France
Facility Name
Investigational Site 3310
City
Brest
Country
France
Facility Name
Investigational Site 3333
City
Cannes
Country
France
Facility Name
Investigational Site 3327
City
Colombes Cedex
Country
France
Facility Name
Investigational Site 3323
City
Dijon
Country
France
Facility Name
Investigational Site 3307
City
Grenoble
Country
France
Facility Name
Investigational Site 3322
City
Grenoble
Country
France
Facility Name
Investigational Site 3325
City
Hetztessy
Country
France
Facility Name
Investigational Site 3328
City
Le Mans
Country
France
Facility Name
Investigational Site 3339
City
Lille
Country
France
City
Lormont
Country
France
Facility Name
Investigational Site 3318
City
Lyon
Country
France
Facility Name
Investigational Site 3303
City
Montpellier
Country
France
City
Nantes
Country
France
Facility Name
Investigational Site 3319
City
Nice
Country
France
Facility Name
Investigational Site 3308
City
Paris
Country
France
Facility Name
Investigational Site 3312
City
Paris
Country
France
Facility Name
Investigational Site 3313
City
Paris
Country
France
Facility Name
Investigational Site 3337
City
Paris
Country
France
Facility Name
Investigational Site 3335
City
Pessac
Country
France
Facility Name
Investigational Site 3341
City
Pessac
Country
France
Facility Name
Investigational Site 3336
City
Pierre Benite
Country
France
City
Roskilde
Country
France
City
Saint Aubin Surscie
Country
France
Facility Name
Investigational Site 3305
City
Saint-Etienne Cedex
Country
France
Facility Name
Investigational Site 3316
City
Toulon
Country
France
Facility Name
Investigational Site 1718
City
Berlin
Country
Germany
Facility Name
Investigational Site 1720
City
Bielefeld
Country
Germany
Facility Name
Investigational Site 1715
City
Bruchsal
Country
Germany
Facility Name
Investigational Site 1700
City
Darmstadt
Country
Germany
Facility Name
Investigational Site 1719
City
Dortmund
Country
Germany
Facility Name
Investigational Site 1701
City
Dresden
Country
Germany
Facility Name
Investigational Site 1707
City
Dresden
Country
Germany
Facility Name
Investigational Site 1721
City
Hamburg
Country
Germany
City
Magdeburg
Country
Germany
Facility Name
Investigational Site 1712
City
Mainz
Country
Germany
Facility Name
Investigational Site 1704
City
Munchen
Country
Germany
Facility Name
Investigational Site 1714
City
Nordhausen
Country
Germany
Facility Name
Investigational Site 1711
City
Paderborn
Country
Germany
Facility Name
Investigational Site 1706
City
Tubingen
Country
Germany
Facility Name
Investigational Site 1708
City
Witten
Country
Germany
Facility Name
Investigational Site 5413
City
Baja
Country
Hungary
Facility Name
Investigational Site 5401
City
Budapest
Country
Hungary
Facility Name
Investigational Site 5404
City
Budapest
Country
Hungary
Facility Name
Investigational Site 5409
City
Budapest
Country
Hungary
Facility Name
Investigational Site 5414
City
Budapest
Country
Hungary
Facility Name
Investigational Site 5400
City
Debrecen
Country
Hungary
Facility Name
Investigational Site 5402
City
Kecskemet
Country
Hungary
Facility Name
Investigational Site 5405
City
Kistarcsa
Country
Hungary
City
Maglodi
Country
Hungary
Facility Name
Investigational Site 5407
City
Miskolc
Country
Hungary
Facility Name
Investigational Site 5410
City
Pecs
Country
Hungary
City
Rakoczi
Country
Hungary
Facility Name
Investigational Site 5403
City
Szentes
Country
Hungary
Facility Name
Investigational Site 5408
City
Szombathely
Country
Hungary
Facility Name
Investigational Site 5412
City
Zalaegerszeg
Country
Hungary
City
Zrinyi
Country
Hungary
City
Ahmedabad
Country
India
City
Andhra Pradesh
Country
India
Facility Name
Investigational Site 4402
City
Bangalore
Country
India
Facility Name
Investigational Site 4405
City
Bangalore
Country
India
Facility Name
Investigational Site 4442
City
Bangalore
Country
India
Facility Name
Investigational Site 4459
City
Bangalore
Country
India
Facility Name
Investigational Site 4460
City
Bangalore
Country
India
Facility Name
Investigational Site 4472
City
Bangalore
Country
India
City
Gujarat
Country
India
City
Gurgaon
Country
India
City
Haryana
Country
India
Facility Name
Investigational Site 5514
City
Holon
Country
India
Facility Name
Investigational Site 4407
City
Hyderabad
Country
India
Facility Name
Investigational Site 4430
City
Hyderabad
Country
India
Facility Name
Investigational Site 4444
City
Hyderabad
Country
India
Facility Name
Investigational Site 4451
City
Hyderabad
Country
India
City
Karnataka
Country
India
City
Kerala
Country
India
Facility Name
Investigational Site 4420
City
Lucknow
Country
India
City
Madhya Pradesh
Country
India
City
Maharashtra
Country
India
Facility Name
Investigational Site 4409
City
Mumbai
Country
India
Facility Name
Investigational Site 4424
City
Mumbai
Country
India
Facility Name
Investigational Site 4419
City
New Delhi
Country
India
Facility Name
Investigational Site 4428
City
New Delhi
Country
India
Facility Name
Investigational Site 4441
City
New Delhi
Country
India
Facility Name
Investigational Site 4425
City
Pune
Country
India
Facility Name
Investigational Site 4438
City
Pune
Country
India
Facility Name
Investigational Site 4443
City
Pune
Country
India
Facility Name
Investigational Site 4462
City
Pune
Country
India
City
Punjab
Country
India
City
Rajasthan
Country
India
Facility Name
Investigational Site 4470
City
Secunderbad
Country
India
City
Tamil Nadu
Country
India
City
Uttar Pradesh
Country
India
City
Vadodara
Country
India
City
Visakhapatnam
Country
India
City
Afula
Country
Israel
City
Ashkelon
Country
Israel
City
Hadera
Country
Israel
Facility Name
Investigational Site 5506
City
Haifa
Country
Israel
Facility Name
Investigational Site 5508
City
Haifa
Country
Israel
Facility Name
Investigational Site 5500
City
Holon
Country
Israel
Facility Name
Investigational Site 5501
City
Jerusalem
Country
Israel
Facility Name
Investigational Site 5505
City
Kfar Saba
Country
Israel
Facility Name
Investigational Site 5513
City
Nahariya
Country
Israel
Facility Name
Investigational Site 5510
City
Petah-Tikva
Country
Israel
Facility Name
Investigational Site 5512
City
Poriya
Country
Israel
Facility Name
Investigational Site 5503
City
Tel Aviv
Country
Israel
Facility Name
Investigational Site 5509
City
Tel Hashomer
Country
Israel
Facility Name
Investigational Site 3508
City
Bergamo
Country
Italy
Facility Name
Investigational Site 3506
City
Chieti
Country
Italy
Facility Name
Investigational Site 3500
City
Emilia
Country
Italy
Facility Name
Investigational Site 3504
City
Milano
Country
Italy
City
Padova
Country
Italy
Facility Name
Investigational Site 3502
City
Palermo
Country
Italy
Facility Name
Investigational Site 3507
City
Parma
Country
Italy
Facility Name
Investigational Site 3501
City
Pavia
Country
Italy
Facility Name
Investigational Site 3505
City
Rozzano
Country
Italy
Facility Name
Investigational Site 3510
City
Udine
Country
Italy
Facility Name
Investigational Site 3503
City
Varese
Country
Italy
Facility Name
Investigational Site 3509
City
Venezia
Country
Italy
Facility Name
Investigational Site 6137
City
Aichi
Country
Japan
Facility Name
Investigational Site 6104
City
Aomori
Country
Japan
Facility Name
Investigational Site 6117
City
Chiba
Country
Japan
Facility Name
Investigational Site 6119
City
Fukuoka
Country
Japan
City
Fukuoka
Country
Japan
Facility Name
Investigational Site 6110
City
Fukushima
Country
Japan
Facility Name
Investigational Site 6150
City
Hiroshima
Country
Japan
Facility Name
Investigational Site 6138
City
Hokkaido
Country
Japan
Facility Name
Investigational Site 6141
City
Hokkaido
Country
Japan
Facility Name
Investigational Site 6133
City
Hyogo
Country
Japan
City
Hyogo
Country
Japan
Facility Name
Investigational Site 6114
City
Ishikawa
Country
Japan
Facility Name
Investigational Site 6144
City
Kagoshima
Country
Japan
Facility Name
Investigational Site 6112
City
Kanagawa
Country
Japan
Facility Name
Investigational Site 6123
City
Kumamoto
Country
Japan
Facility Name
Investigational Site 6147
City
Kumamoto
Country
Japan
Facility Name
Investigational Site 6148
City
Kumamoto
Country
Japan
Facility Name
Investigational Site 6129
City
Mie
Country
Japan
Facility Name
Investigational Site 6146
City
Nagano
Country
Japan
Facility Name
Investigational Site 6139
City
Nagasaki
Country
Japan
Facility Name
Investigational Site 6107
City
Niigata
Country
Japan
Facility Name
Investigational Site 6152
City
Okayama
Country
Japan
Facility Name
Investigational Site 6135
City
Okinawa
Country
Japan
Facility Name
Investigational Site 6132
City
Osaka
Country
Japan
Facility Name
Investigational Site 6130
City
Sapporo
Country
Japan
Facility Name
Investigational Site 6143
City
Shizuoka
Country
Japan
Facility Name
Investigational Site 6102
City
Tokyo
Country
Japan
Facility Name
Investigational Site 6105
City
Tokyo
Country
Japan
Facility Name
Investigational Site 6113
City
Tokyo
Country
Japan
Facility Name
Investigational Site 6142
City
Tokyo
Country
Japan
Facility Name
Investigational Site 6145
City
Tokyo
Country
Japan
Facility Name
Investigational Site 6149
City
Tottori
Country
Japan
Facility Name
Investigational Site 4513
City
Busan
Country
Korea, Republic of
Facility Name
Investigational Site 4509
City
Daegu
Country
Korea, Republic of
Facility Name
Investigational Site 4501
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Investigational Site 4506
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site 4507
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site 4508
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site 4515
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site 1303
City
Zapopan
State/Province
Jalisco
Country
Mexico
Facility Name
Investigational Site 1302
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Investigational Site 1311
City
Col. Lomas Altas C.P
Country
Mexico
Facility Name
Investigational Site 1304
City
Guadalajara
Country
Mexico
Facility Name
Investigational Site 1312
City
Guadalajara
Country
Mexico
Facility Name
Investigational Site 1300
City
Hermosillo
Country
Mexico
Facility Name
Investigational Site 1305
City
Monterrey, Nuevo Leon
Country
Mexico
Facility Name
Investigational Site 1308
City
San Luis Potosi
Country
Mexico
Facility Name
Investigational Site 1301
City
Yucatan
Country
Mexico
Facility Name
Investigational Site 3608
City
Alkmaar
Country
Netherlands
Facility Name
Investigational Site 3607
City
Almere
Country
Netherlands
Facility Name
Investigational Site 3617
City
Amersfoort
Country
Netherlands
Facility Name
Investigational Site 3611
City
Amsterdam
Country
Netherlands
Facility Name
Investigational Site 3609
City
Assen
Country
Netherlands
Facility Name
Investigational Site 3603
City
Groningen
Country
Netherlands
Facility Name
Investigational Site 3612
City
Heerlen
Country
Netherlands
Facility Name
Investigational Site 3613
City
Hoofddorp
Country
Netherlands
Facility Name
Investigational Site 3602
City
Nijmegen
Country
Netherlands
Facility Name
Investigational Site 3615
City
Rotterdam
Country
Netherlands
Facility Name
Investigational Site 4702
City
Auckland
Country
New Zealand
Facility Name
Investigational Site 4703
City
Auckland
Country
New Zealand
Facility Name
Investigational Site 4700
City
Christchurch
Country
New Zealand
Facility Name
Investigational Site 4704
City
Wellington
Country
New Zealand
Facility Name
Investigational Site 3701
City
Fredrikstad
Country
Norway
Facility Name
Investigational Site 3700
City
Oslo
Country
Norway
City
Pasig City
Country
Philippines
Facility Name
Investigational Site 4800
City
Quezon City
Country
Philippines
Facility Name
Investigational site 4801
City
Quezon City
Country
Philippines
Facility Name
Investigational Site 4802
City
Quezon City
Country
Philippines
Facility Name
Investigational Site 5015
City
Bialystok
Country
Poland
Facility Name
Investigational Site 5005
City
Krakow
Country
Poland
Facility Name
Investigational Site 5019
City
Olsztyn
Country
Poland
Facility Name
Investigational Site 5018
City
Tarnow
Country
Poland
Facility Name
Investigational Site 5003
City
Warszawa
Country
Poland
Facility Name
Investigational Site 5007
City
Warszawa
Country
Poland
Facility Name
Investigational Site 5008
City
Warszawa
Country
Poland
Facility Name
Investigational Site 5014
City
Warszawa
Country
Poland
City
Barnaul
Country
Russian Federation
Facility Name
Investigational Site 3023
City
Chelyabinsk
Country
Russian Federation
Facility Name
Investigational Site 3017
City
Irkutsk
Country
Russian Federation
Facility Name
Investigational Site 3019
City
Kemerovo
Country
Russian Federation
Facility Name
Investigational Site 3020
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Investigational Site 3030
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Investigational Site 3029
City
Moscow
Country
Russian Federation
Facility Name
Investigational Site 3028
City
Novosibirsk
Country
Russian Federation
Facility Name
Investigational Site 3009
City
Omsk
Country
Russian Federation
Facility Name
Investigational Site 3022
City
Ryazan
Country
Russian Federation
City
Saratov
Country
Russian Federation
Facility Name
Investigational Site 3024
City
Sochi
Country
Russian Federation
Facility Name
Investigational Site 3000
City
St. Petersburg
Country
Russian Federation
Facility Name
Investigational Site 3003
City
St. Petersburg
Country
Russian Federation
Facility Name
Investigational Site 3027
City
St. Petersburg
Country
Russian Federation
Facility Name
Investigational Site 3025
City
Tyumen
Country
Russian Federation
Facility Name
Investigational Site 3016
City
Ufa
Country
Russian Federation
Facility Name
Investigational Site 3004
City
Yaroslavl
Country
Russian Federation
Facility Name
Investigational Site 3010
City
Yaroslavl
Country
Russian Federation
Facility Name
Investigational Site 5900
City
Outram Road
Country
Singapore
Facility Name
Investigational Site 5902
City
Singapore
Country
Singapore
Facility Name
Investigational Site 4912
City
Cape Town
Country
South Africa
Facility Name
Investigational Site 4907
City
Centurion
Country
South Africa
Facility Name
Investigational Site 4901
City
Johannesburg
Country
South Africa
Facility Name
Investigational Site 4905
City
Johannesburg
Country
South Africa
Facility Name
Investigational Site 4909
City
Johannesburg
Country
South Africa
Facility Name
Investigational Site 4910
City
Johannesburg
Country
South Africa
Facility Name
Investigational Site 4908
City
Lyttleton
Country
South Africa
Facility Name
Investigational Site 4903
City
Pretoria
Country
South Africa
Facility Name
Investigational Site 4906
City
Pretoria
Country
South Africa
Facility Name
Investigational Site 4904
City
Somerset West
Country
South Africa
Facility Name
Investigational Site 4900
City
Worcester
Country
South Africa
Facility Name
Investigational site 1503
City
Barcelona
Country
Spain
Facility Name
Investigational Site 1502
City
Cabra
Country
Spain
Facility Name
Investigational Site 3900
City
Hallingsjo
Country
Sweden
Facility Name
Investigational Site 3904
City
Kristianstad
Country
Sweden
Facility Name
Investigational Site 3903
City
Stockholm
Country
Sweden
Facility Name
Investigational Site 3905
City
Stockholm
Country
Sweden
Facility Name
Investigational Site 3902
City
Sundsvall
Country
Sweden
Facility Name
Investigational Site 4103
City
Aarau
Country
Switzerland
Facility Name
Investigational Site 4110
City
Basel
Country
Switzerland
Facility Name
Investigational Site 4104
City
Bellinzona
Country
Switzerland
Facility Name
Investigational Site 4102
City
Chur
Country
Switzerland
Facility Name
Investigational Site 4109
City
Lausanne
Country
Switzerland
Facility Name
Investigational Site 4100
City
Luzern
Country
Switzerland
City
Hualien City
Country
Taiwan
Facility Name
Investigational Site 5104
City
Kaohsiung
Country
Taiwan
Facility Name
Investigational Site 5105
City
Taichung
Country
Taiwan
Facility Name
Investigational Site 5101
City
Taipei
Country
Taiwan
Facility Name
Investigational Site 5103
City
Taipei
Country
Taiwan
Facility Name
Investigational Site 5200
City
Bangkok
Country
Thailand
Facility Name
Investigational Site 5202
City
Bangkok
Country
Thailand
Facility Name
Investigational Site 5203
City
Nakhorn Nayok
Country
Thailand
Facility Name
Investigational Site 5702
City
Ankara
Country
Turkey
Facility Name
Investigational Site 5703
City
Ankara
Country
Turkey
Facility Name
Investigational Site 5702
City
Istanbul
Country
Turkey
Facility Name
Investigational Site 5706
City
Istanbul
Country
Turkey
City
Chernigiv
Country
Ukraine
Facility Name
Investigational Site 4008
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Investigational Site 4010
City
Donetsk
Country
Ukraine
Facility Name
Investigational Site 4000
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Investigational Site 4002
City
Kharkiv
Country
Ukraine
Facility Name
Investigational Site 4001
City
Kiev
Country
Ukraine
Facility Name
Investigational Site 4007
City
Ternopil
Country
Ukraine
Facility Name
Investigational Site 4009
City
Uzhgorod
Country
Ukraine
Facility Name
Investigational Site 4003
City
Vinnitsya
Country
Ukraine
Facility Name
Investigational Site 4006
City
Zaporizhzhia
Country
Ukraine
Facility Name
Investigational Site 7005
City
Coventry
Country
United Kingdom
Facility Name
Investigational Site 7006
City
Hull
Country
United Kingdom
Facility Name
Investigational Site 7000
City
London
Country
United Kingdom
Facility Name
Investigational Site 7003
City
London
Country
United Kingdom
Facility Name
Investigational Site 7004
City
London
Country
United Kingdom
Facility Name
Investigational Site 7001
City
Newcastle
Country
United Kingdom
Facility Name
Investigational Site 7007
City
Plymouth
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
29248859
Citation
Vanassche T, Verhamme P, Wells PS, Segers A, Ageno W, Brekelmans MPA, Chen CZ, Cohen AT, Grosso MA, Medina AP, Mercuri MF, Winters SM, Zhang G, Weitz JI, Raskob GE, Buller HR. Impact of age, comorbidity, and polypharmacy on the efficacy and safety of edoxaban for the treatment of venous thromboembolism: An analysis of the randomized, double-blind Hokusai-VTE trial. Thromb Res. 2018 Feb;162:7-14. doi: 10.1016/j.thromres.2017.12.005. Epub 2017 Dec 13.
Results Reference
derived
PubMed Identifier
28689179
Citation
Vandell AG, Walker J, Brown KS, Zhang G, Lin M, Grosso MA, Mercuri MF. Genetics and clinical response to warfarin and edoxaban in patients with venous thromboembolism. Heart. 2017 Nov;103(22):1800-1805. doi: 10.1136/heartjnl-2016-310901. Epub 2017 Jul 8.
Results Reference
derived
PubMed Identifier
27570090
Citation
Brekelmans MP, Ageno W, Beenen LF, Brenner B, Buller HR, Chen CZ, Cohen AT, Grosso MA, Meyer G, Raskob G, Segers A, Vanassche T, Verhamme P, Wells PS, Zhang G, Weitz JI. Recurrent venous thromboembolism in patients with pulmonary embolism and right ventricular dysfunction: a post-hoc analysis of the Hokusai-VTE study. Lancet Haematol. 2016 Sep;3(9):e437-45. doi: 10.1016/S2352-3026(16)30080-1.
Results Reference
derived
PubMed Identifier
27476789
Citation
Raskob GE, van Es N, Segers A, Angchaisuksiri P, Oh D, Boda Z, Lyons RM, Meijer K, Gudz I, Weitz JI, Zhang G, Lanz H, Mercuri MF, Buller HR; Hokusai-VTE investigators. Edoxaban for venous thromboembolism in patients with cancer: results from a non-inferiority subgroup analysis of the Hokusai-VTE randomised, double-blind, double-dummy trial. Lancet Haematol. 2016 Aug;3(8):e379-87. doi: 10.1016/S2352-3026(16)30057-6. Epub 2016 Jul 1.
Results Reference
derived
PubMed Identifier
26179767
Citation
Nakamura M, Wang YQ, Wang C, Oh D, Yin WH, Kimura T, Miyazaki K, Abe K, Mercuri M, Lee LH, Segers A, Buller H. Efficacy and safety of edoxaban for treatment of venous thromboembolism: a subanalysis of East Asian patients in the Hokusai-VTE trial. J Thromb Haemost. 2015 Sep;13(9):1606-14. doi: 10.1111/jth.13055. Epub 2015 Aug 27.
Results Reference
derived
PubMed Identifier
23991658
Citation
Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31. Erratum In: N Engl J Med. 2014 Jan 23;370(4):390.
Results Reference
derived
PubMed Identifier
21861537
Citation
Camm AJ, Bounameaux H. Edoxaban: a new oral direct factor xa inhibitor. Drugs. 2011 Aug 20;71(12):1503-26. doi: 10.2165/11595540-000000000-00000.
Results Reference
derived

Learn more about this trial

Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

We'll reach out to this number within 24 hrs