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Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Primary Purpose

Heart Failure, Type 2 Diabetes Mellitus

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sotagliflozin
Placebo
Sponsored by
Lexicon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Type 2 Diabetes Mellitus.
  • Admitted to the hospital, or urgent heart failure visit for worsening heart failure.
  • Prior diagnosis of heart failure (> 3 months).
  • Prior chronic treatment for heart failure with a loop diuretic (eg furosemide, torsemide, bumetanide) for > 30 days.
  • Randomized when hemodynamically stable, prior to hospital discharge or within 3 days of discharge.
  • Brain natriuretic peptide (BNP) ≥150 picograms per milliliter (pg/mL) (≥450 pg/mL for participants with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600 pg/mL (≥1800 pg/mL for participants with atrial fibrillation).
  • Participants with Left Ventricular Ejection Fraction <40% should be on beta-blockers and renin-angiotensin-aldosterone system (RAAS) inhibitors as per local guidelines unless contraindicated.
  • Signed written informed consent.

Exclusion criteria:

  • Age < 18 years or > 85 years.
  • Worsening heart failure attributed to other causes such as pulmonary embolism, stroke, heart attack.
  • Cardiac surgery or coronary procedure within 1 month or planned during study.
  • Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization.
  • Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study.
  • Acute coronary syndromes within 3 months prior to Randomization.
  • Hemodynamically significant uncorrected primary valvular disease.
  • Significant pulmonary disease contributing substantially to the participant's dyspnea.
  • End stage Heart Failure.
  • History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar coma within 3 months prior to screening.
  • History of stroke within 3 months prior to randomization.
  • History of dialysis within 1 year prior to randomization.
  • History of solid organ transplant or on a transplant list (if heart transplant, defined as status 1 transplant).
  • Severe kidney disease as defined by glomerular filtration rate (eGFR) <30 milliliter per minute per 1.72 meter square (mL/min/1.73 m^2).
  • Pregnancy.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sotagliflozin

Placebo

Arm Description

Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.

Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.

Outcomes

Primary Outcome Measures

Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.

Secondary Outcome Measures

Total Number of Occurrences of HHF and Urgent HF Visits
Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Total Number of Deaths From Cardiovascular Causes
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomisation. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomisation of HHF, urgent HF visits, CV Death and HF while hospitalised. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Total Number of Deaths From Any Cause
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4
KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement. An analysis of covariance (ANCOVA) model was used for analysis.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
eGFR is a test for renal function. A blood sample was collected and was sent to a central laboratory. eGFR was calculated by the Modification of Diet in Renal Disease (MDRD) equation reported as milliliters/minute/1.73 meter squared (mL/min/1.73 m^2). A mixed model for repeated measures (MMRM) was used for analysis.

Full Information

First Posted
April 30, 2018
Last Updated
September 30, 2022
Sponsor
Lexicon Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03521934
Brief Title
Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients With Type 2 Diabetes POST Worsening Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to business decision
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
June 5, 2020 (Actual)
Study Completion Date
June 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexicon Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF) Secondary Objectives: To compare the effects of sotagliflozin to placebo on: The total occurrences of HHF and urgent visit for HF The occurrence of CV death The occurrence of all-cause mortality The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score Change in estimated glomerular filtration rate (eGFR)
Detailed Description
The estimated study duration for a given participants will be approximately 3 to 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sotagliflozin
Arm Type
Experimental
Arm Description
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
Intervention Type
Drug
Intervention Name(s)
Sotagliflozin
Other Intervention Name(s)
SAR439954
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
Description
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Time Frame
Up to 21.9 months
Secondary Outcome Measure Information:
Title
Total Number of Occurrences of HHF and Urgent HF Visits
Description
Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Time Frame
Up to 21.9 months
Title
Total Number of Deaths From Cardiovascular Causes
Description
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Time Frame
Up to 21.9 months
Title
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
Description
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomisation. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Time Frame
Up to 21.9 months
Title
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
Description
Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomisation of HHF, urgent HF visits, CV Death and HF while hospitalised. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Time Frame
Up to 21.9 months
Title
Total Number of Deaths From Any Cause
Description
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Time Frame
Up to 21.9 months
Title
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4
Description
KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement. An analysis of covariance (ANCOVA) model was used for analysis.
Time Frame
Baseline to Month 4
Title
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Description
eGFR is a test for renal function. A blood sample was collected and was sent to a central laboratory. eGFR was calculated by the Modification of Diet in Renal Disease (MDRD) equation reported as milliliters/minute/1.73 meter squared (mL/min/1.73 m^2). A mixed model for repeated measures (MMRM) was used for analysis.
Time Frame
Baseline up to 21.9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Type 2 Diabetes Mellitus. Admitted to the hospital, or urgent heart failure visit for worsening heart failure. Prior diagnosis of heart failure (> 3 months). Prior chronic treatment for heart failure with a loop diuretic (eg furosemide, torsemide, bumetanide) for > 30 days. Randomized when hemodynamically stable, prior to hospital discharge or within 3 days of discharge. Brain natriuretic peptide (BNP) ≥150 picograms per milliliter (pg/mL) (≥450 pg/mL for participants with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600 pg/mL (≥1800 pg/mL for participants with atrial fibrillation). Participants with Left Ventricular Ejection Fraction <40% should be on beta-blockers and renin-angiotensin-aldosterone system (RAAS) inhibitors as per local guidelines unless contraindicated. Signed written informed consent. Exclusion criteria: Age < 18 years or > 85 years. Worsening heart failure attributed to other causes such as pulmonary embolism, stroke, heart attack. Cardiac surgery or coronary procedure within 1 month or planned during study. Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization. Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study. Acute coronary syndromes within 3 months prior to Randomization. Hemodynamically significant uncorrected primary valvular disease. Significant pulmonary disease contributing substantially to the participant's dyspnea. End stage Heart Failure. History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar coma within 3 months prior to screening. History of stroke within 3 months prior to randomization. History of dialysis within 1 year prior to randomization. History of solid organ transplant or on a transplant list (if heart transplant, defined as status 1 transplant). Severe kidney disease as defined by glomerular filtration rate (eGFR) <30 milliliter per minute per 1.72 meter square (mL/min/1.73 m^2). Pregnancy. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suman Wason, MD
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 8400128
City
Alexander City
State/Province
Alabama
ZIP/Postal Code
35010
Country
United States
Facility Name
Investigational Site Number 8400109
City
Cottonwood
State/Province
Arizona
ZIP/Postal Code
86326
Country
United States
Facility Name
Investigational Site Number 8400032
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site Number 8400080
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site Number 8400075
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Investigational Site Number 8400069
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Investigational Site Number 8400008
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Investigational Site Number 8400063
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Investigational Site Number 8400127
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Investigational Site Number 8400007
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Investigational Site Number 8400036
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Investigational Site Number 8400033
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Investigational Site Number 8400049
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Investigational Site Number 8400028
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Investigational Site Number 8400029
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Investigational Site Number 8400037
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Investigational Site Number 8400046
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Investigational Site Number 8400009
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Investigational Site Number 8400079
City
Homestead
State/Province
Florida
ZIP/Postal Code
33033
Country
United States
Facility Name
Investigational Site Number 8400031
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Investigational Site Number 8400022
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Investigational Site Number 8400098
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
Investigational Site Number 8400058
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Investigational Site Number 8400105
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigational Site Number 8400082
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Investigational Site Number 8400057
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Investigational Site Number 8400006
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Investigational Site Number 8400035
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Investigational Site Number 8400042
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Investigational Site Number 8400004
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Investigational Site Number 8400073
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1020
Country
United States
Facility Name
Investigational Site Number 8400118
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Investigational Site Number 8400067
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Investigational Site Number 8400043
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Investigational Site Number 8400072
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Investigational Site Number 8400055
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46060
Country
United States
Facility Name
Investigational Site Number 8400020
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303-3400
Country
United States
Facility Name
Investigational Site Number 8400122
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Investigational Site Number 8400091
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
Facility Name
Investigational Site Number 8400030
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Investigational Site Number 8400065
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Investigational Site Number 8400012
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Investigational Site Number 8400001
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Investigational Site Number 8400077
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Investigational Site Number 8400062
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Investigational Site Number 8400017
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Investigational Site Number 8400107
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Investigational Site Number 8400056
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Investigational Site Number 8400019
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Investigational Site Number 8400103
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Facility Name
Investigational Site Number 8400132
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Investigational Site Number 8400130
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Investigational Site Number 8400083
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Investigational Site Number 8400071
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Investigational Site Number 8400015
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450-2736
Country
United States
Facility Name
Investigational Site Number 8400050
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Investigational Site Number 8400131
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Investigational Site Number 8400097
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Investigational Site Number 8400061
City
Bronx
State/Province
New York
ZIP/Postal Code
10468-3904
Country
United States
Facility Name
Investigational Site Number 8400051
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Investigational Site Number 8400111
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Investigational Site Number 8400045
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Investigational Site Number 8400085
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Investigational Site Number 8400078
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Investigational Site Number 8400087
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Investigational Site Number 8400047
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Investigational Site Number 8400095
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Investigational Site Number 8400099
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43699
Country
United States
Facility Name
Investigational Site Number 8400121
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Investigational Site Number 8400054
City
Arlington
State/Province
Oregon
ZIP/Postal Code
19001
Country
United States
Facility Name
Investigational Site Number 8400134
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Investigational Site Number 8400044
City
Natrona Heights
State/Province
Pennsylvania
ZIP/Postal Code
15065
Country
United States
Facility Name
Investigational Site Number 8400115
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Investigational Site Number 8400039
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Investigational Site Number 8400114
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Investigational Site Number 8400100
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Investigational Site Number 8400059
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Investigational Site Number 8400092
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Investigational Site Number 8400104
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Investigational Site Number 8400040
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Investigational Site Number 8400088
City
Greenville
State/Province
Tennessee
ZIP/Postal Code
30000
Country
United States
Facility Name
Investigational Site Number 8400089
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Investigational Site Number 8400053
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Investigational Site Number 8400041
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78521
Country
United States
Facility Name
Investigational Site Number 8400074
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Investigational Site Number 8400016
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site Number 8400123
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Investigational Site Number 8400101
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Investigational Site Number 8400066
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Facility Name
Investigational Site Number 8400093
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20109
Country
United States
Facility Name
Investigational Site Number 8400003
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249-0001
Country
United States
Facility Name
Investigational Site Number 8400126
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
Facility Name
Investigational Site Number 8400038
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Investigational Site Number 8400048
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54220
Country
United States
Facility Name
Investigational Site Number 0320031
City
Caba
ZIP/Postal Code
1430
Country
Argentina
Facility Name
Investigational Site Number 0320009
City
Caba
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Investigational Site Number 0320016
City
Capital Federal
ZIP/Postal Code
1405
Country
Argentina
Facility Name
Investigational Site Number 0320002
City
Ciudad De Buenos Aires
ZIP/Postal Code
C1428DCO
Country
Argentina
Facility Name
Investigational Site Number 0320011
City
Cordoba
ZIP/Postal Code
X5000AAX
Country
Argentina
Facility Name
Investigational Site Number 0320010
City
Cordoba
ZIP/Postal Code
X5004BAL
Country
Argentina
Facility Name
Investigational Site Number 0320022
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
Facility Name
Investigational Site Number 0320001
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Facility Name
Investigational Site Number 0320024
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Investigational Site Number 0320003
City
Córdoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Facility Name
Investigational Site Number 0320025
City
Córdoba
ZIP/Postal Code
X5006IKK
Country
Argentina
Facility Name
Investigational Site Number 0320029
City
La Plata
ZIP/Postal Code
B1900AXI
Country
Argentina
Facility Name
Investigational Site Number 0320007
City
La Plata
ZIP/Postal Code
B1906ESC
Country
Argentina
Facility Name
Investigational Site Number 0320006
City
Merlo
ZIP/Postal Code
B1722COV
Country
Argentina
Facility Name
Investigational Site Number 0320005
City
Moron
ZIP/Postal Code
B1708CGU
Country
Argentina
Facility Name
Investigational Site Number 0320012
City
Olivos
ZIP/Postal Code
1638
Country
Argentina
Facility Name
Investigational Site Number 0320023
City
Quilmes
ZIP/Postal Code
1878
Country
Argentina
Facility Name
Investigational Site Number 0320018
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Investigational Site Number 0320013
City
Rosario
ZIP/Postal Code
S2000DSR
Country
Argentina
Facility Name
Investigational Site Number 0320008
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Facility Name
Investigational Site Number 0320020
City
San Martin
ZIP/Postal Code
B1685CSQ
Country
Argentina
Facility Name
Investigational Site Number 0320028
City
San Miguel De Tucuman
ZIP/Postal Code
T4000IFL
Country
Argentina
Facility Name
Investigational Site Number 0320019
City
San Miguel De Tucuman
ZIP/Postal Code
T4000NIL
Country
Argentina
Facility Name
Investigational Site Number 0320017
City
Santa Fe
ZIP/Postal Code
S3000EOZ
Country
Argentina
Facility Name
Investigational Site Number 0320015
City
Santa Fe
ZIP/Postal Code
S3000FWO
Country
Argentina
Facility Name
Investigational Site Number 0320030
City
Tucuman
ZIP/Postal Code
T4000JCU
Country
Argentina
Facility Name
Investigational Site Number 0320004
City
Villa Belgrano
ZIP/Postal Code
X5021FPQ
Country
Argentina
Facility Name
Investigational Site Number 0320014
City
Villa Maria
ZIP/Postal Code
X5900JKA
Country
Argentina
Facility Name
Investigational Site Number 0360007
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Investigational Site Number 0360001
City
Wollongong
ZIP/Postal Code
2500
Country
Australia
Facility Name
Investigational Site Number 0400006
City
Braunau
ZIP/Postal Code
5280
Country
Austria
Facility Name
Investigational Site Number 0400002
City
Feldkirch
ZIP/Postal Code
6800
Country
Austria
Facility Name
Investigational Site Number 0400007
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Investigational Site Number 0400005
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Investigational Site Number 0400004
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Investigational Site Number 0400003
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Investigational Site Number 0400001
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Investigational Site Number 0560002
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Investigational Site Number 0560007
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Investigational Site Number 0560004
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Investigational Site Number 0560001
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Investigational Site Number 0560003
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Investigational Site Number 0560005
City
Mol
ZIP/Postal Code
2400
Country
Belgium
Facility Name
Investigational Site Number 0560006
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Investigational Site Number 0560008
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Investigational Site Number 0760009
City
Belo Horizonte
ZIP/Postal Code
30110-908
Country
Brazil
Facility Name
Investigational Site Number 0760024
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Investigational Site Number 0760002
City
Blumenau
ZIP/Postal Code
89020-430
Country
Brazil
Facility Name
Investigational Site Number 0760011
City
Brasilia
ZIP/Postal Code
70390-903
Country
Brazil
Facility Name
Investigational Site Number 0760005
City
Campinas
ZIP/Postal Code
13060-080
Country
Brazil
Facility Name
Investigational Site Number 0760006
City
Campinas
ZIP/Postal Code
13092-111
Country
Brazil
Facility Name
Investigational Site Number 0760023
City
Fortaleza
ZIP/Postal Code
60840-285
Country
Brazil
Facility Name
Investigational Site Number 0760018
City
Goiania
ZIP/Postal Code
74210050
Country
Brazil
Facility Name
Investigational Site Number 0760010
City
Passo Fundo
ZIP/Postal Code
99010-180
Country
Brazil
Facility Name
Investigational Site Number 0760003
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Investigational Site Number 0760020
City
Porto Alegre
ZIP/Postal Code
90035 003
Country
Brazil
Facility Name
Investigational Site Number 0760021
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Investigational Site Number 0760007
City
Porto Alegre
ZIP/Postal Code
90620-001
Country
Brazil
Facility Name
Investigational Site Number 0760013
City
Porto Alegre
ZIP/Postal Code
91350-250
Country
Brazil
Facility Name
Investigational Site Number 0760004
City
Recife
ZIP/Postal Code
52051-380
Country
Brazil
Facility Name
Investigational Site Number 0760001
City
Sao Jose Do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Investigational Site Number 0760012
City
Sao Paulo
ZIP/Postal Code
04012-909
Country
Brazil
Facility Name
Investigational Site Number 0760008
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Investigational Site Number 0760017
City
Votuporanga
ZIP/Postal Code
15500-003
Country
Brazil
Facility Name
Investigational Site Number 1240013
City
Cambridge
ZIP/Postal Code
N1R 6V6
Country
Canada
Facility Name
Investigational Site Number 1240006
City
Granby
ZIP/Postal Code
J2G 1T7
Country
Canada
Facility Name
Investigational Site Number 1240015
City
Halifax
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Investigational Site Number 1240002
City
Montreal
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Investigational Site Number 1240019
City
Montreal
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Investigational Site Number 1240018
City
Montreal
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Investigational Site Number 1240004
City
Peterborough
ZIP/Postal Code
K9J 0B2
Country
Canada
Facility Name
Investigational Site Number 1240014
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Investigational Site Number 1240007
City
Scarborough
ZIP/Postal Code
M1B 4Z8
Country
Canada
Facility Name
Investigational Site Number 1240005
City
Sherbrooke
ZIP/Postal Code
J1G 2E8
Country
Canada
Facility Name
Investigational Site Number 1240011
City
Toronto
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Investigational Site Number 1240001
City
Toronto
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Investigational Site Number 1240009
City
Trois-Rivières
ZIP/Postal Code
G9A 5C5
Country
Canada
Facility Name
Investigational Site Number 1520009
City
Concepción
Country
Chile
Facility Name
Investigational Site Number 1520011
City
Santiago
ZIP/Postal Code
80004005
Country
Chile
Facility Name
Investigational Site Number 1520006
City
Santiago
ZIP/Postal Code
8053095
Country
Chile
Facility Name
Investigational Site Number 1520003
City
Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Investigational Site Number 1520004
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 1520005
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 1520012
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 1520013
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 1520002
City
Temuco
Country
Chile
Facility Name
Investigational Site Number 1520010
City
Vina Del Mar
Country
Chile
Facility Name
Investigational Site Number 1520001
City
Viña Del Mar
Country
Chile
Facility Name
Investigational Site Number 2030001
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Investigational Site Number 2030003
City
Brno
ZIP/Postal Code
63600
Country
Czechia
Facility Name
Investigational Site Number 2030004
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Investigational Site Number 2030014
City
Kolin 3
ZIP/Postal Code
28002
Country
Czechia
Facility Name
Investigational Site Number 2030010
City
Kromeriz
ZIP/Postal Code
76701
Country
Czechia
Facility Name
Investigational Site Number 2030005
City
Liberec
ZIP/Postal Code
46063
Country
Czechia
Facility Name
Investigational Site Number 2030013
City
Mestec Kralove
ZIP/Postal Code
28903
Country
Czechia
Facility Name
Investigational Site Number 2030018
City
Praha 10
ZIP/Postal Code
10100
Country
Czechia
Facility Name
Investigational Site Number 2030002
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Investigational Site Number 2030007
City
Praha 5 - Motol
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Investigational Site Number 2030017
City
Praha 5
ZIP/Postal Code
15030
Country
Czechia
Facility Name
Investigational Site Number 2030011
City
Prerov
ZIP/Postal Code
75152
Country
Czechia
Facility Name
Investigational Site Number 2030015
City
Pribram I
ZIP/Postal Code
26101
Country
Czechia
Facility Name
Investigational Site Number 2030006
City
Slany
ZIP/Postal Code
27401
Country
Czechia
Facility Name
Investigational Site Number 2080003
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Investigational Site Number 2080002
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Investigational Site Number 2080001
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Investigational Site Number 2080005
City
København Nv
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Investigational Site Number 2080004
City
Ålborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Investigational Site Number 2460004
City
Espoo
ZIP/Postal Code
02740
Country
Finland
Facility Name
Investigational Site Number 2460001
City
Helsinki
ZIP/Postal Code
00029 HUS
Country
Finland
Facility Name
Investigational Site Number 2460002
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Facility Name
Investigational Site Number 2460003
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Investigational Site Number 2460005
City
Seinäjoki
ZIP/Postal Code
60220
Country
Finland
Facility Name
Investigational Site Number 2500009
City
Chambray Les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Investigational Site Number 2500008
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Investigational Site Number 2500004
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Investigational Site Number 2500002
City
Le Coudray
ZIP/Postal Code
28360
Country
France
Facility Name
Investigational Site Number 2500001
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number 2500007
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number 2500012
City
Nice Cedex 1
ZIP/Postal Code
06002
Country
France
Facility Name
Investigational Site Number 2500003
City
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
Investigational Site Number 2500006
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Investigational Site Number 2500005
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Investigational Site Number 2500013
City
Vandoeuvre-Les-Nancy Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Investigational Site Number 2760020
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Investigational Site Number 2760016
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Investigational Site Number 2760013
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Investigational Site Number 2760019
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Investigational Site Number 2760001
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Investigational Site Number 2760002
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Investigational Site Number 2760025
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Investigational Site Number 2760005
City
Bonn
ZIP/Postal Code
53115
Country
Germany
Facility Name
Investigational Site Number 2760021
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Facility Name
Investigational Site Number 2760035
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Investigational Site Number 2760032
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Investigational Site Number 2760006
City
Dortmund
ZIP/Postal Code
44379
Country
Germany
Facility Name
Investigational Site Number 2760029
City
Erfurt
ZIP/Postal Code
99097
Country
Germany
Facility Name
Investigational Site Number 2760018
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Investigational Site Number 2760033
City
Frankfurt Am Main
ZIP/Postal Code
65929
Country
Germany
Facility Name
Investigational Site Number 2760009
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Investigational Site Number 2760022
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Investigational Site Number 2760031
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Investigational Site Number 2760027
City
Köln
ZIP/Postal Code
50733
Country
Germany
Facility Name
Investigational Site Number 2760034
City
Lahr
ZIP/Postal Code
77933
Country
Germany
Facility Name
Investigational Site Number 2760030
City
Langen
ZIP/Postal Code
63225
Country
Germany
Facility Name
Investigational Site Number 2760014
City
Leverkusen
ZIP/Postal Code
51375
Country
Germany
Facility Name
Investigational Site Number 2760036
City
Limburg
ZIP/Postal Code
65549
Country
Germany
Facility Name
Investigational Site Number 2760012
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Investigational Site Number 2760028
City
Merseburg
ZIP/Postal Code
06217
Country
Germany
Facility Name
Investigational Site Number 2760011
City
Rotenburg An Der Fulda
ZIP/Postal Code
36199
Country
Germany
Facility Name
Investigational Site Number 2760015
City
Rüsselsheim
ZIP/Postal Code
65428
Country
Germany
Facility Name
Investigational Site Number 2760007
City
Witten
ZIP/Postal Code
58455
Country
Germany
Facility Name
Investigational Site Number 2760026
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Investigational Site Number 3000012
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
Investigational Site Number 3000004
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Investigational Site Number 3000002
City
Chalkida
ZIP/Postal Code
34 100
Country
Greece
Facility Name
Investigational Site Number 3000009
City
Elefsina
ZIP/Postal Code
19600
Country
Greece
Facility Name
Investigational Site Number 3000003
City
Haidari
ZIP/Postal Code
12462
Country
Greece
Facility Name
Investigational Site Number 3000005
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Investigational Site Number 3000007
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
Facility Name
Investigational Site Number 3000006
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Investigational Site Number 3000001
City
N. Ionia
ZIP/Postal Code
14233
Country
Greece
Facility Name
Investigational Site Number 3000008
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Investigational Site Number 3480018
City
Berettyóújfalu
ZIP/Postal Code
4100
Country
Hungary
Facility Name
Investigational Site Number 3480012
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Investigational Site Number 3480016
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Investigational Site Number 3480010
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Investigational Site Number 3480019
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Investigational Site Number 3480001
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Investigational Site Number 3480015
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Investigational Site Number 3480011
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Investigational Site Number 3480014
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Investigational Site Number 3480005
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Investigational Site Number 3480007
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Investigational Site Number 3480002
City
Dombóvár
ZIP/Postal Code
7200
Country
Hungary
Facility Name
Investigational Site Number 3480017
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Investigational Site Number 3480008
City
Hódmezövásárhely
ZIP/Postal Code
6800
Country
Hungary
Facility Name
Investigational Site Number 3480020
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Investigational Site Number 3480009
City
Komárom
ZIP/Postal Code
2921
Country
Hungary
Facility Name
Investigational Site Number 3480013
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Investigational Site Number 3480003
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Investigational Site Number 3480006
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Investigational Site Number 3760013
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Investigational Site Number 3760004
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Investigational Site Number 3760005
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Investigational Site Number 3760006
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Investigational Site Number 3760003
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Investigational Site Number 3760008
City
Jerusalem
Country
Israel
Facility Name
Investigational Site Number 3760010
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Investigational Site Number 3760002
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Investigational Site Number 3760011
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Investigational Site Number 3760009
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Investigational Site Number 3760001
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Investigational Site Number 3760012
City
Tiberias
ZIP/Postal Code
15208
Country
Israel
Facility Name
Investigational Site Number 3800006
City
Arzignano (Vi)
ZIP/Postal Code
36071
Country
Italy
Facility Name
Investigational Site Number 3800011
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Investigational Site Number 3800017
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Facility Name
Investigational Site Number 3800005
City
Cortona
ZIP/Postal Code
52044
Country
Italy
Facility Name
Investigational Site Number 3800009
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Investigational Site Number 3800020
City
Gallipoli
ZIP/Postal Code
73014
Country
Italy
Facility Name
Investigational Site Number 3800003
City
Legnago
ZIP/Postal Code
37045
Country
Italy
Facility Name
Investigational Site Number 3800023
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Investigational Site Number 3800002
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
Investigational Site Number 3800012
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
Investigational Site Number 3800008
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Investigational Site Number 3800013
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Investigational Site Number 3800022
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Investigational Site Number 3800018
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Investigational Site Number 3800004
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Investigational Site Number 3800016
City
Pozzilli
ZIP/Postal Code
86077
Country
Italy
Facility Name
Investigational Site Number 3800014
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Investigational Site Number 3800010
City
Roma
ZIP/Postal Code
00153
Country
Italy
Facility Name
Investigational Site Number 3800021
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Investigational Site Number 3800019
City
Scorrano
ZIP/Postal Code
73020
Country
Italy
Facility Name
Investigational Site Number 3800007
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Investigational Site Number 4100008
City
Bucheon-Si
ZIP/Postal Code
14754
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100010
City
Busan
ZIP/Postal Code
49267
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100004
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100001
City
Hwaseong-Si
ZIP/Postal Code
18450
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100003
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100005
City
Seongnam-Si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100002
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100007
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100011
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100009
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Investigational Site Number 4280004
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
Investigational Site Number 4280002
City
Liepaja
ZIP/Postal Code
LV-3414
Country
Latvia
Facility Name
Investigational Site Number 4280001
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Investigational Site Number 4280003
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Investigational Site Number 4400002
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Investigational Site Number 4400005
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Investigational Site Number 4400004
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Investigational Site Number 4400006
City
Siauliai
ZIP/Postal Code
LT-76231
Country
Lithuania
Facility Name
Investigational Site Number 4400001
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Investigational Site Number 4400003
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Investigational Site Number 5280003
City
Amsterdam
ZIP/Postal Code
1034 CS
Country
Netherlands
Facility Name
Investigational Site Number 5280001
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Investigational Site Number 5280007
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Investigational Site Number 5280002
City
Doetinchem
ZIP/Postal Code
7009 BL
Country
Netherlands
Facility Name
Investigational Site Number 5280004
City
Hertogenbosch
ZIP/Postal Code
5223 GZ 's
Country
Netherlands
Facility Name
Investigational Site Number 5280006
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Investigational Site Number 5280008
City
Sneek
ZIP/Postal Code
8601
Country
Netherlands
Facility Name
Investigational Site Number 5280005
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
Investigational Site Number 5540007
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Investigational Site Number 5540006
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Investigational Site Number 5540002
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Investigational Site Number 5540004
City
Lower Hutt
Country
New Zealand
Facility Name
Investigational Site Number 5540005
City
New Plymouth
Country
New Zealand
Facility Name
Investigational Site Number 5540003
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
Investigational Site Number 6160007
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Investigational Site Number 6160017
City
Gdansk
ZIP/Postal Code
80-462
Country
Poland
Facility Name
Investigational Site Number 6160002
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Investigational Site Number 6160014
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Investigational Site Number 6160021
City
Krakow
ZIP/Postal Code
30-693
Country
Poland
Facility Name
Investigational Site Number 6160001
City
Krakow
ZIP/Postal Code
31 -202
Country
Poland
Facility Name
Investigational Site Number 6160003
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Investigational Site Number 6160012
City
Krakow
Country
Poland
Facility Name
Investigational Site Number 6160011
City
Leczna
ZIP/Postal Code
21-010
Country
Poland
Facility Name
Investigational Site Number 6160016
City
Lubin
ZIP/Postal Code
59-301
Country
Poland
Facility Name
Investigational Site Number 6160005
City
Miechow
ZIP/Postal Code
32-200
Country
Poland
Facility Name
Investigational Site Number 6160022
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Investigational Site Number 6160006
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Investigational Site Number 6160013
City
Warszawa
ZIP/Postal Code
00-685
Country
Poland
Facility Name
Investigational Site Number 6160004
City
Warszawa
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Investigational Site Number 6160020
City
Warszawa
ZIP/Postal Code
04-073
Country
Poland
Facility Name
Investigational Site Number 6160024
City
Warszawa
ZIP/Postal Code
04-349
Country
Poland
Facility Name
Investigational Site Number 6160008
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Investigational Site Number 6160015
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Investigational Site Number 6200012
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Investigational Site Number 6200001
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Investigational Site Number 6200011
City
Guilhufe - Penafiel
ZIP/Postal Code
4564-007
Country
Portugal
Facility Name
Investigational Site Number 6200004
City
Guimarães
ZIP/Postal Code
4810-061
Country
Portugal
Facility Name
Investigational Site Number 6200006
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
Facility Name
Investigational Site Number 6200002
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Investigational Site Number 6200008
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Investigational Site Number 6200007
City
Vila Franca De Xira
ZIP/Postal Code
2600-009
Country
Portugal
Facility Name
Investigational Site Number 6200003
City
Vila Nova Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Investigational Site Number 6200005
City
Vila Real
ZIP/Postal Code
5000-508
Country
Portugal
Facility Name
Investigational Site Number 6420014
City
Arad
ZIP/Postal Code
310037
Country
Romania
Facility Name
Investigational Site Number 6420006
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
Investigational Site Number 6420015
City
Braila
ZIP/Postal Code
810325
Country
Romania
Facility Name
Investigational Site Number 6420013
City
Bucharest
ZIP/Postal Code
010825
Country
Romania
Facility Name
Investigational Site Number 6420019
City
Bucuresti
ZIP/Postal Code
014461
Country
Romania
Facility Name
Investigational Site Number 6420011
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Investigational Site Number 6420008
City
Bucuresti
ZIP/Postal Code
022322
Country
Romania
Facility Name
Investigational Site Number 6420007
City
Bucuresti
ZIP/Postal Code
050659
Country
Romania
Facility Name
Investigational Site Number 6420002
City
Cluj Napoca
ZIP/Postal Code
400001
Country
Romania
Facility Name
Investigational Site Number 6420003
City
Cluj Napoca
ZIP/Postal Code
400347
Country
Romania
Facility Name
Investigational Site Number 6420016
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Investigational Site Number 6420005
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Investigational Site Number 6420004
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Facility Name
Investigational Site Number 6420018
City
Satu Mare
ZIP/Postal Code
440156
Country
Romania
Facility Name
Investigational Site Number 6420001
City
Targu Mures
ZIP/Postal Code
540103
Country
Romania
Facility Name
Investigational Site Number 6420012
City
Tg-Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Investigational Site Number 6420009
City
Timisoara
ZIP/Postal Code
300079
Country
Romania
Facility Name
Investigational Site Number 6420010
City
Timisoara
ZIP/Postal Code
300723
Country
Romania
Facility Name
Investigational Site Number 6430026
City
Ivanovo
ZIP/Postal Code
153012
Country
Russian Federation
Facility Name
Investigational Site Number 6430023
City
Kazan
ZIP/Postal Code
420087
Country
Russian Federation
Facility Name
Investigational Site Number 6430002
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Investigational Site Number 6430006
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Investigational Site Number 6430005
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Investigational Site Number 6430004
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Investigational Site Number 6430022
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Investigational Site Number 6430024
City
Moscow
ZIP/Postal Code
119192
Country
Russian Federation
Facility Name
Investigational Site Number 6430001
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Investigational Site Number 6430003
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Investigational Site Number 6430010
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Investigational Site Number 6430018
City
Nizhniy Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
Investigational Site Number 6430013
City
Rostov-Na-Donu
ZIP/Postal Code
344068
Country
Russian Federation
Facility Name
Investigational Site Number 6430011
City
Saint-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Investigational Site Number 6430017
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Investigational Site Number 6430025
City
St-Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Investigational Site Number 6430007
City
St-Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Investigational Site Number 6430012
City
St-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Investigational Site Number 6430009
City
St-Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Investigational Site Number 6430016
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Facility Name
Investigational Site Number 7030003
City
Bratislava 3 - Kramare
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Investigational Site Number 7030004
City
Bratislava 37
ZIP/Postal Code
833 48
Country
Slovakia
Facility Name
Investigational Site Number 7030001
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Investigational Site Number 7030010
City
Brezno
ZIP/Postal Code
97742
Country
Slovakia
Facility Name
Investigational Site Number 7030009
City
Dolny Kubin
ZIP/Postal Code
02614
Country
Slovakia
Facility Name
Investigational Site Number 7030002
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Investigational Site Number 7030011
City
Nitra
ZIP/Postal Code
950 01
Country
Slovakia
Facility Name
Investigational Site Number 7030008
City
Trnava
ZIP/Postal Code
91775
Country
Slovakia
Facility Name
Investigational Site Number 7240016
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Investigational Site Number 7240015
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Investigational Site Number 7240020
City
Hospitalet De Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Investigational Site Number 7240006
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Investigational Site Number 7240005
City
Las Palmas De Gran Canaria
ZIP/Postal Code
35020
Country
Spain
Facility Name
Investigational Site Number 7240021
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Investigational Site Number 7240008
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site Number 7240022
City
Manises
ZIP/Postal Code
46940
Country
Spain
Facility Name
Investigational Site Number 7240007
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Investigational Site Number 7240004
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number 7240014
City
Olot
ZIP/Postal Code
17800
Country
Spain
Facility Name
Investigational Site Number 7240009
City
San Sebastián De Los Reyes
ZIP/Postal Code
28702
Country
Spain
Facility Name
Investigational Site Number 7240003
City
Sanlúcar De Barrameda
ZIP/Postal Code
11540
Country
Spain
Facility Name
Investigational Site Number 7240001
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Investigational Site Number 7240019
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Investigational Site Number 7240012
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Investigational Site Number 7240011
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Investigational Site Number 7240010
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Investigational Site Number 7240002
City
Villamartín
ZIP/Postal Code
11650
Country
Spain
Facility Name
Investigational Site Number 7240013
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Investigational Site Number 7240018
City
Úbeda
ZIP/Postal Code
23400
Country
Spain
Facility Name
Investigational Site Number 7520004
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
Facility Name
Investigational Site Number 7520002
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Investigational Site Number 7520006
City
Skellefteå
ZIP/Postal Code
931 86
Country
Sweden
Facility Name
Investigational Site Number 7520007
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Investigational Site Number 7520008
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Investigational Site Number 7520001
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Investigational Site Number 7560001
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Investigational Site Number 7560003
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Investigational Site Number 7920008
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Investigational Site Number 7920006
City
Corum
ZIP/Postal Code
19200
Country
Turkey
Facility Name
Investigational Site Number 7920005
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Investigational Site Number 7920002
City
Haseki/ Istanbul
ZIP/Postal Code
34034
Country
Turkey
Facility Name
Investigational Site Number 7920011
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Investigational Site Number 7920012
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Investigational Site Number 7920003
City
Kocaeli
ZIP/Postal Code
41300
Country
Turkey
Facility Name
Investigational Site Number 7920004
City
Mersin
ZIP/Postal Code
33169
Country
Turkey
Facility Name
Investigational Site Number 7920001
City
Sivas
ZIP/Postal Code
58140
Country
Turkey
Facility Name
Investigational Site Number 7920010
City
Trabzon
ZIP/Postal Code
61040
Country
Turkey
Facility Name
Investigational Site Number 8260005
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Investigational Site Number 8260010
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Investigational Site Number 8260008
City
Chelmsford
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Investigational Site Number 8260009
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Investigational Site Number 8260002
City
Newcastle
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Investigational Site Number 8260001
City
Oldham
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Facility Name
Investigational Site Number 8260003
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
Investigational Site Number 8260006
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Investigational Site Number 8260004
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Investigational Site Number 8260007
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Citations:
PubMed Identifier
34152828
Citation
Szarek M, Bhatt DL, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Banks P, Tesfaye E, Ezekowitz JA, Verma S, Pitt B; SOLOIST-WHF committees and investigators. Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure : A Randomized Trial. Ann Intern Med. 2021 Aug;174(8):1065-1072. doi: 10.7326/M21-0651. Epub 2021 Jun 22.
Results Reference
derived
PubMed Identifier
33200892
Citation
Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.
Results Reference
derived

Learn more about this trial

Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

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