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Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03315143
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objectives:

To demonstrate that, when compared to placebo in patients with type 2 diabetes (T2D), cardiovascular (CV) risk factors, and moderately impaired renal function, sotagliflozin:

  • Does not increase the risk of cardiovascular events including death from cardiovascular disease, non-fatal heart attack and non-fatal stroke;
  • Reduces the risk of death from CV disease or hospitalization for heart failure.

Secondary Objectives:

  • To demonstrate that, when compared to placebo in patients with T2D, CV risk factors, and moderately impaired renal function, sotagliflozin:
  • Reduces cardiovascular events including death from cardiovascular disease, non-fatal heart attack and non-fatal stroke;
  • Reduces risk of progression of kidney disease;
  • Reduces cardiovascular events including death from cardiovascular disease and emergency treatment for heart failure;
  • Reduces death from cardiovascular disease;
  • Reduces death from any cause.
  • To assess the safety and tolerability of sotagliflozin.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Chronic Kidney Diseases Drug: Sotagliflozin (SAR439954) Drug: Placebo Phase 3

Detailed Description:
Study duration per participant is approximately 27 to 51 months, assuming approximately 24 months of recruitment, and approximately 27 months of follow-up after the last patient is randomized.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sotagliflozin
Sotagliflozin dose 1 (1 tablet), once daily with possible uptitration in the first 6 months to dose 2 (2 tablets)
Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral


Placebo Comparator: Placebo
Placebo dose 1 (1 tablet), once daily with possible uptitration in the first 6 months to dose 2 (2 tablets)
Drug: Placebo

Pharmaceutical form: tablet

Route of administration: oral





Primary Outcome Measures :
  1. Time to first Major Adverse Cardiovascular Event (MACE) [ Time Frame: Baseline to approximately 51 months ]
    Time to the first occurrence of any of the following clinical events: Cardiovascular death, Non-fatal myocardial infarction (MI), Non-fatal stroke

  2. Time to cardiovascular death or hospitalization for heart failure [ Time Frame: Baseline to approximately 51 months ]
    Time to the first occurrence of any of the following clinical events: Cardiovascular death; Hospitalization for heart failure


Secondary Outcome Measures :
  1. Time to first composite renal event [ Time Frame: Baseline to approximately 51 months ]
    Time to the first occurrence of any of the following clinical events in patients with baseline eGFR ≥30 mL/min/1.73 m2: Sustained ≥50% decrease of eGFR from baseline (for ≥30 days); chronic dialysis, renal transplant or sustained eGFR <15 ml/min/1.73 m2 (for ≥30 days)

  2. Time to first composite renal event in subgroup of patients with macroalbuminuria [ Time Frame: Baseline to approximately 51 months ]
    Time to the first occurrence of any of the following clinical events in patients with baseline eGFR ≥30 mL/min/1.73 m2 and baseline UACR ≥300 mg/g: Sustained ≥50% decrease of eGFR from baseline (for ≥30 days); chronic dialysis, renal transplant or sustained eGFR <15 ml/min/1.73 m2 (for ≥30 days

  3. Total number of heart failure events [ Time Frame: Baseline to approximately 51 months ]
    Total number (ie, including recurrent events) of the following clinical events: Cardiovascular death, Hospitalization for heart failure; Urgent heart failure visit

  4. Cardiovascular (CV) death [ Time Frame: Baseline to approximately 51 months ]
    Time to CV death

  5. All cause mortality [ Time Frame: Baseline to approximately 51 months ]
    Time to all-cause mortality



Information from the National Library of Medicine

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) ≥ 7%.
  • Estimated glomerular filtration rate (eGFR) ≥ 25 and ≤ 60 mL/min/1.73 m2.
  • Age 18 years or older with at least one major cardiovascular risk factor or age 55 years or older with at least two minor cardiovascular risk factors.
  • Signed written informed consent.

Exclusion criteria:

  • Antihyperglycemic treatment has not been stable within 12 weeks prior to screening.
  • Planned coronary procedure or surgery after randomization.
  • 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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315143


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com

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Locations
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United States, Alabama
Investigational Site Number 8400017 Recruiting
Birmingham, Alabama, United States, 35205
Investigational Site Number 8400096 Recruiting
Sheffield, Alabama, United States, 35660
United States, Arizona
Investigational Site Number 8400004 Recruiting
Mesa, Arizona, United States, 85206
Investigational Site Number 8400059 Recruiting
Mesa, Arizona, United States, 85210
Investigational Site Number 8400021 Recruiting
Peoria, Arizona, United States, 85381
Investigational Site Number 8400014 Recruiting
Surprise, Arizona, United States, 85374
United States, Arkansas
Investigational Site Number 8400071 Recruiting
Little Rock, Arkansas, United States, 72211
United States, California
Investigational Site Number 8400039 Recruiting
Beverly Hills, California, United States, 90211
Investigational Site Number 8400042 Recruiting
Concord, California, United States, 94520
Investigational Site Number 8400089 Recruiting
Fresno, California, United States, 93720
Investigational Site Number 8400006 Recruiting
Huntington Park, California, United States, 90255
Investigational Site Number 8400036 Recruiting
Long Beach, California, United States, 90807
Investigational Site Number 8400073 Recruiting
Los Angeles, California, United States, 90017
Investigational Site Number 8400084 Recruiting
Los Angeles, California, United States, 90022-4302
Investigational Site Number 8400035 Recruiting
Los Gatos, California, United States, 95032
Investigational Site Number 8400043 Recruiting
Northridge, California, United States, 91325
Investigational Site Number 8400025 Recruiting
Sacramento, California, United States, 95821
Investigational Site Number 8400018 Recruiting
San Dimas, California, United States, 91713
Investigational Site Number 8400070 Recruiting
Temecula, California, United States, 92591
United States, Connecticut
Investigational Site Number 8400013 Recruiting
Waterbury, Connecticut, United States, 06708
United States, Florida
Investigational Site Number 8400095 Recruiting
Bradenton, Florida, United States, 34209
Investigational Site Number 8400090 Recruiting
Clearwater, Florida, United States, 33756
Investigational Site Number 8400121 Recruiting
Clearwater, Florida, United States, 33756
Investigational Site Number 8400049 Recruiting
Cooper City, Florida, United States, 33024
Investigational Site Number 8400092 Recruiting
Hialeah, Florida, United States, 33012
Investigational Site Number 8400134 Recruiting
Jacksonville, Florida, United States, 32204
Investigational Site Number 8400055 Recruiting
Jacksonville, Florida, United States, 32207-4966
Investigational Site Number 8400056 Completed
Jacksonville, Florida, United States, 32216
Investigational Site Number 8400031 Recruiting
Jacksonville, Florida, United States, 32277
Investigational Site Number 8400037 Recruiting
Maitland, Florida, United States, 32751
Investigational Site Number 8400078 Recruiting
Miami, Florida, United States, 33126
Investigational Site Number 8400117 Recruiting
Miami, Florida, United States, 33135
Investigational Site Number 8400119 Recruiting
Miami, Florida, United States, 33135
Investigational Site Number 8400118 Recruiting
Miami, Florida, United States, 33165
Investigational Site Number 8400105 Recruiting
Miami, Florida, United States, 33174
Investigational Site Number 8400120 Recruiting
Miami, Florida, United States, 33176
Investigational Site Number 8400088 Recruiting
North Miami Beach, Florida, United States, 33162
Investigational Site Number 8400106 Recruiting
Opa-locka, Florida, United States, 33054
Investigational Site Number 8400063 Recruiting
Ormond Beach, Florida, United States, 32174
Investigational Site Number 8400087 Recruiting
Palm Harbor, Florida, United States, 34684-3609
Investigational Site Number 8400026 Recruiting
Pembroke Pines, Florida, United States, 33028
Investigational Site Number 8400058 Recruiting
Saint Petersburg, Florida, United States, 33713
Investigational Site Number 8400108 Completed
Spring Hill, Florida, United States, 34609
Investigational Site Number 8400051 Recruiting
Tampa, Florida, United States, 33624
United States, Georgia
Investigational Site Number 8400123 Recruiting
Atlanta, Georgia, United States, 30303
Investigational Site Number 8400076 Recruiting
Roswell, Georgia, United States, 30076
United States, Hawaii
Investigational Site Number 8400033 Recruiting
Honolulu, Hawaii, United States, 96814
United States, Illinois
Investigational Site Number 8400085 Recruiting
Arlington Heights, Illinois, United States, 60005
Investigational Site Number 8400104 Recruiting
Chicago, Illinois, United States, 60611
Investigational Site Number 8400027 Recruiting
Chicago, Illinois, United States, 60612
Investigational Site Number 8400124 Recruiting
Chicago, Illinois, United States, 60612
Investigational Site Number 8400001 Recruiting
Chicago, Illinois, United States, 60616
Investigational Site Number 8400052 Recruiting
Crystal Lake, Illinois, United States, 60012
Investigational Site Number 8400028 Recruiting
Springfield, Illinois, United States, 62711
United States, Indiana
Investigational Site Number 8400125 Recruiting
Michigan City, Indiana, United States, 46360
Investigational Site Number 8400098 Recruiting
Valparaiso, Indiana, United States, 46383
United States, Iowa
Investigational Site Number 8400003 Recruiting
Des Moines, Iowa, United States, 50314
United States, Kansas
Investigational Site Number 8400081 Recruiting
Topeka, Kansas, United States, 66606
United States, Kentucky
Investigational Site Number 8400041 Recruiting
Louisville, Kentucky, United States, 40213
United States, Maine
Investigational Site Number 8400080 Recruiting
Bangor, Maine, United States, 04401
United States, Michigan
Investigational Site Number 8400002 Recruiting
Flint, Michigan, United States, 48504
Investigational Site Number 8400069 Recruiting
Flint, Michigan, United States, 48532-3447
Investigational Site Number 8400016 Recruiting
Troy, Michigan, United States, 48098
United States, Minnesota
Investigational Site Number 8400023 Recruiting
Saint Cloud, Minnesota, United States, 56303
United States, Missouri
Investigational Site Number 8400066 Recruiting
Kansas City, Missouri, United States, 64111
Investigational Site Number 8400024 Recruiting
Saint Louis, Missouri, United States, 63136
Investigational Site Number 8400130 Recruiting
Washington, Missouri, United States, 63090
United States, Nebraska
Investigational Site Number 8400045 Recruiting
Omaha, Nebraska, United States, 68198-4100
United States, Nevada
Investigational Site Number 8400009 Recruiting
Las Vegas, Nevada, United States, 89148
United States, New York
Investigational Site Number 8400101 Recruiting
Albany, New York, United States, 12206
Investigational Site Number 8400061 Recruiting
Laurelton, New York, United States, 11413
Investigational Site Number 8400046 Recruiting
New York, New York, United States, 10029-6501
Investigational Site Number 8400112 Completed
Rosedale, New York, United States, 11422
Investigational Site Number 8400062 Completed
Smithtown, New York, United States, 11787
United States, North Carolina
Investigational Site Number 8400079 Recruiting
Greenville, North Carolina, United States, 27834-5704
Investigational Site Number 8400020 Recruiting
Morehead City, North Carolina, United States, 28557
Investigational Site Number 8400048 Recruiting
Morehead City, North Carolina, United States, 28557
Investigational Site Number 8400010 Recruiting
Morganton, North Carolina, United States, 28655
United States, North Dakota
Investigational Site Number 8400072 Recruiting
Fargo, North Dakota, United States, 58103
United States, Ohio
Investigational Site Number 8400038 Recruiting
Cincinnati, Ohio, United States, 45219
Investigational Site Number 8400007 Recruiting
Cincinnati, Ohio, United States, 45241
Investigational Site Number 8400015 Recruiting
Columbus, Ohio, United States, 43210
Investigational Site Number 8400113 Recruiting
Lorain, Ohio, United States, 44053
Investigational Site Number 8400011 Recruiting
Mentor, Ohio, United States, 44060
United States, Oregon
Investigational Site Number 8400109 Recruiting
Bend, Oregon, United States, 97702
United States, Pennsylvania
Investigational Site Number 8400047 Recruiting
Beaver, Pennsylvania, United States, 15009
Investigational Site Number 8400019 Recruiting
Greensburg, Pennsylvania, United States, 15601
Investigational Site Number 8400097 Recruiting
Indiana, Pennsylvania, United States, 15701-3578
Investigational Site Number 8400032 Recruiting
Levittown, Pennsylvania, United States, 19056-2404
Investigational Site Number 8400053 Recruiting
Philadelphia, Pennsylvania, United States, 19107
Investigational Site Number 8400012 Recruiting
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Investigational Site Number 8400064 Recruiting
Anderson, South Carolina, United States, 29621
Investigational Site Number 8400030 Recruiting
Greer, South Carolina, United States, 29651
Investigational Site Number 8400029 Recruiting
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Investigational Site Number 8400040 Recruiting
Memphis, Tennessee, United States, 38163
United States, Texas
Investigational Site Number 8400114 Recruiting
Arlington, Texas, United States, 76015
Investigational Site Number 8400067 Recruiting
Corpus Christi, Texas, United States, 78814
Investigational Site Number 8400082 Recruiting
Dallas, Texas, United States, 75231
Investigational Site Number 8400022 Recruiting
El Paso, Texas, United States, 79935
Investigational Site Number 8400099 Recruiting
Houston, Texas, United States, 77043
Investigational Site Number 8400103 Recruiting
Houston, Texas, United States, 77070
Investigational Site Number 8400086 Recruiting
Katy, Texas, United States, 77450
Investigational Site Number 8400100 Recruiting
Mesquite, Texas, United States, 75150
Investigational Site Number 8400094 Completed
Plano, Texas, United States, 75093
Investigational Site Number 8400116 Recruiting
San Antonio, Texas, United States, 78224
Investigational Site Number 8400091 Recruiting
Waco, Texas, United States, 76710
United States, Utah
Investigational Site Number 8400065 Recruiting
Bountiful, Utah, United States, 84010-8903
Investigational Site Number 8400131 Recruiting
Ogden, Utah, United States, 84405
United States, Vermont
Investigational Site Number 8400093 Recruiting
Bennington, Vermont, United States, 05201
Investigational Site Number 8400060 Recruiting
South Burlington, Vermont, United States, 05403
United States, Virginia
Investigational Site Number 8400133 Recruiting
Danville, Virginia, United States, 24541-2834
Investigational Site Number 8400054 Recruiting
Fairfax, Virginia, United States, 22039
Investigational Site Number 8400132 Completed
Falls Church, Virginia, United States, 22044
Investigational Site Number 8400034 Recruiting
Manassas, Virginia, United States, 20110
Investigational Site Number 8400050 Recruiting
Norfolk, Virginia, United States, 23510
Investigational Site Number 8400044 Recruiting
Richmond, Virginia, United States, 23235
Investigational Site Number 8400111 Recruiting
Richmond, Virginia, United States, 23249
United States, Washington
Investigational Site Number 8400083 Recruiting
Federal Way, Washington, United States, 98003
Investigational Site Number 8400068 Recruiting
Spokane, Washington, United States, 99207
Argentina
Investigational Site Number 0320025 Recruiting
Buenos Aires, Argentina, C1128AAF
Investigational Site Number 0320016 Recruiting
Buenos Aires, Argentina
Investigational Site Number 0320029 Recruiting
Buenos Aires, Argentina
Investigational Site Number 0320017 Recruiting
Caba, Argentina, 1120
Investigational Site Number 0320002 Recruiting
Caba, Argentina, C1093AAS
Investigational Site Number 0320004 Recruiting
Caba, Argentina, C1118AAE
Investigational Site Number 0320018 Recruiting
Caba, Argentina, C1119ACN
Investigational Site Number 0320019 Recruiting
Caba, Argentina
Investigational Site Number 0320027 Recruiting
Capital Federal, Argentina, C1056ABJ
Investigational Site Number 0320015 Recruiting
Capital Federal, Argentina, C1179AAB
Investigational Site Number 0320014 Recruiting
Ciudad Autonoma De Bs.As, Argentina, C1428DCO
Investigational Site Number 0320023 Recruiting
Ciudad Autonoma De Buenos Aire, Argentina, C1204AAD
Investigational Site Number 0320009 Recruiting
Ciudadela, Argentina, B1702BML
Investigational Site Number 0320001 Recruiting
Cordoba, Argentina, X5000AAX
Investigational Site Number 0320008 Recruiting
Coronel Suarez, Argentina, B7540GHD
Investigational Site Number 0320011 Recruiting
Corrientes, Argentina, W3400AMZ
Investigational Site Number 0320028 Recruiting
La Plata, Argentina, B1900AXI
Investigational Site Number 0320006 Recruiting
La Plata, Argentina, B1906ESC
Investigational Site Number 0320003 Recruiting
Mar Del Plata, Argentina, B7600FYK
Investigational Site Number 0320024 Recruiting
Mar Del Plata, Argentina, B7600FZN
Investigational Site Number 0320020 Recruiting
Merlo, Argentina, B1722COV
Investigational Site Number 0320007 Recruiting
Ramos Mejia, Argentina, B1704ETD
Investigational Site Number 0320030 Recruiting
Rosario, Argentina, S2000CVD
Investigational Site Number 0320026 Recruiting
Rosario, Argentina, S2000DEJ
Investigational Site Number 0320012 Recruiting
Salta, Argentina, 4400
Investigational Site Number 0320021 Recruiting
San Miguel De Tucuman, Argentina, T4000ICL
Investigational Site Number 0320013 Recruiting
Santa Fe, Argentina, S3000FWO
Investigational Site Number 0320022 Recruiting
Temperley, Argentina, 1842
Investigational Site Number 0320005 Recruiting
Villa Maria, Argentina, X5900JKA
Australia
Investigational Site Number 0360014 Recruiting
Adelaide, Australia, 5000
Investigational Site Number 0360004 Recruiting
Box Hill, Australia, 3128
Investigational Site Number 0360015 Recruiting
Elizabeth Vale, Australia, 5112
Investigational Site Number 0360005 Recruiting
Fitzroy, Australia, 3065
Investigational Site Number 0360018 Recruiting
Fremantle, Australia, 6160
Investigational Site Number 0360007 Recruiting
Fullarton, Australia, 5063
Investigational Site Number 0360002 Recruiting
Gosford, Australia, 2250
Investigational Site Number 0360016 Recruiting
Heidelberg, Australia, 3081
Investigational Site Number 0360010 Recruiting
Herston, Australia, 4029
Investigational Site Number 0360009 Recruiting
Liverpool, Australia, 2170
Investigational Site Number 0360017 Recruiting
Melbourne, Australia, 3004
Investigational Site Number 0360001 Recruiting
Merewether, Australia, 2291
Investigational Site Number 0360012 Recruiting
Oaklands Park, Australia, 5046
Investigational Site Number 0360011 Recruiting
Parkville, Australia, 3050
Investigational Site Number 0360008 Recruiting
Redcliffe, Australia, 4020
Investigational Site Number 0360013 Recruiting
Sherwood, Australia, 4075
Investigational Site Number 0360019 Recruiting
St Leonards, Australia, 2065
Investigational Site Number 0360006 Recruiting
Wollongong, Australia, 2500
Belgium
Investigational Site Number 0560004 Recruiting
Bonheiden, Belgium, 2820
Investigational Site Number 0560005 Recruiting
Gent, Belgium, 9000
Investigational Site Number 0560003 Recruiting
Kortrijk, Belgium, 8500
Investigational Site Number 0560002 Recruiting
La-Louvière, Belgium, 7100
Investigational Site Number 0560001 Recruiting
Leuven, Belgium, 3000
Brazil
Investigational Site Number 0760017 Recruiting
Blumenau, Brazil, 89020-430
Investigational Site Number 0760015 Recruiting
Brasilia, Brazil, 70200-730
Investigational Site Number 0760026 Recruiting
Brasilia, Brazil, 70390-903
Investigational Site Number 0760008 Recruiting
Campinas, Brazil, 13015-001
Investigational Site Number 0760005 Recruiting
Campinas, Brazil, 13060-080
Investigational Site Number 0760018 Recruiting
Canoas, Brazil, 92425-900
Investigational Site Number 0760019 Recruiting
Curitiba, Brazil, 80030-110
Investigational Site Number 0760011 Recruiting
Curitiba, Brazil, 80230-130
Investigational Site Number 0760007 Recruiting
Curitiba, Brazil, 80730-150
Investigational Site Number 0760010 Recruiting
Fortaleza, Brazil, 60115-282
Investigational Site Number 0760002 Recruiting
Fortaleza, Brazil, 60170-320
Investigational Site Number 0760004 Recruiting
Fortaleza, Brazil, 60430-350
Investigational Site Number 0760014 Recruiting
Passo Fundo, Brazil, 99010-180
Investigational Site Number 0760025 Recruiting
Porto Alegre, Brazil, 90020-090
Investigational Site Number 0760016 Recruiting
Porto Alegre, Brazil, 90035-170
Investigational Site Number 0760024 Recruiting
Recife, Brazil, 52051-380
Investigational Site Number 0760023 Recruiting
Rio De Janeiro, Brazil, 22271-100
Investigational Site Number 0760001 Recruiting
Sao Jose Do Rio Preto, Brazil, 15090-000
Investigational Site Number 0760012 Recruiting
Sao Jose Dos Campos, Brazil, 12243-280
Investigational Site Number 0760020 Recruiting
Sao Paulo, Brazil, 01228-200
Investigational Site Number 0760013 Recruiting
Sao Paulo, Brazil, 04038-002
Investigational Site Number 0760022 Recruiting
Sao Paulo, Brazil, 04266-010
Investigational Site Number 0760006 Recruiting
Sao Paulo, Brazil, 05403-000
Investigational Site Number 0760009 Recruiting
Sao Paulo, Brazil, 05403-000
Investigational Site Number 0760003 Recruiting
São Paulo, Brazil, 01.228-000
Investigational Site Number 0760021 Recruiting
Vitoria, Brazil, 29055 450
Bulgaria
Investigational Site Number 1000015 Recruiting
Blagoevgrad, Bulgaria, 2700
Investigational Site Number 1000008 Recruiting
Dobrich, Bulgaria, MULTIPROFILE HOSPITA
Investigational Site Number 1000013 Recruiting
Gabrovo, Bulgaria, 5300
Investigational Site Number 1000003 Recruiting
Plovdiv, Bulgaria, 4002
Investigational Site Number 1000016 Recruiting
Ruse, Bulgaria, 7002
Investigational Site Number 1000014 Recruiting
Silistra, Bulgaria, 7500
Investigational Site Number 1000007 Recruiting
Smolyan, Bulgaria, 4700
Investigational Site Number 1000011 Recruiting
Sofia, Bulgaria, 1233
Investigational Site Number 1000004 Recruiting
Sofia, Bulgaria, 1431
Investigational Site Number 1000006 Recruiting
Sofia, Bulgaria, 1431
Investigational Site Number 1000012 Recruiting
Sofia, Bulgaria, 1632
Investigational Site Number 1000017 Recruiting
Sofia, Bulgaria, 1784
Investigational Site Number 1000005 Recruiting
Sofia, Bulgaria, 1797
Investigational Site Number 1000001 Recruiting
Stara Zagora, Bulgaria, 6000
Investigational Site Number 1000018 Recruiting
Stara Zagora, Bulgaria, 6000
Canada
Investigational Site Number 1240002 Recruiting
Brampton, Canada, L6S0C6
Investigational Site Number 1240013 Recruiting
Burlington, Canada, L7M 4Y1
Investigational Site Number 1240021 Recruiting
Calgary, Canada, T2T 5C7
Investigational Site Number 1240005 Recruiting
Calgary, Canada, T2V 4J2
Investigational Site Number 1240029 Recruiting
Concord, Canada, L4K 4M2
Investigational Site Number 1240004 Recruiting
Edmonton, Canada, T5A 4L8
Investigational Site Number 1240010 Recruiting
Edmonton, Canada, T6H 2L4
Investigational Site Number 1240027 Recruiting
Halifax, Canada, B3H 2Y9
Investigational Site Number 1240023 Recruiting
Hamilton, Canada, L8N 3Z5
Investigational Site Number 1240011 Recruiting
London, Canada, N6A 4V2
Investigational Site Number 1240019 Recruiting
Montreal, Canada, H1T 1C8
Investigational Site Number 1240017 Recruiting
Montreal, Canada, H4A 2C6
Investigational Site Number 1240018 Recruiting
Montreal, Canada, H4N 2W2
Investigational Site Number 1240007 Recruiting
Newmarket, Canada, L3Y 5G8
Investigational Site Number 1240026 Recruiting
Oshawa, Canada, L1G 2B9
Investigational Site Number 1240016 Recruiting
Oshawa, Canada, L1J 2K1
Investigational Site Number 1240006 Recruiting
Ottawa, Canada, K1H7W9
Investigational Site Number 1240022 Recruiting
Quebec, Canada, G1G 3Z4
Investigational Site Number 1240025 Recruiting
Quebec, Canada, G1V 4G5
Investigational Site Number 1240014 Recruiting
Quebec, Canada, G1V 4W2
Investigational Site Number 1240003 Recruiting
Quebec, Canada, G1W-4R4
Investigational Site Number 1240034 Recruiting
Saint-Charles-Borromee, Canada, J6E 6J2
Investigational Site Number 1240032 Recruiting
St-Marc-Des-Carrieres, Canada, G0A 4B0
Investigational Site Number 1240033 Recruiting
St. John'S, Canada, A1B 3V6
Investigational Site Number 1240008 Recruiting
Sudbury, Canada, P3E 5M4
Investigational Site Number 1240031 Recruiting
Surrey, Canada, V3V 0C6
Investigational Site Number 1240035 Recruiting
Toronto, Canada, M5S 1B1
Investigational Site Number 1240028 Recruiting
Toronto, Canada, M6G 1M2
Investigational Site Number 1240015 Recruiting
Trois-Rivieres, Canada, G8Z 3R9
Investigational Site Number 1240001 Recruiting
Vancouver, Canada, V5Y 3W2
Investigational Site Number 1240030 Recruiting
Victoria, Canada, V8R 1B2
Chile
Investigational Site Number 1520015 Recruiting
Concepción, Chile, 4070566
Investigational Site Number 1520003 Recruiting
Osorno, Chile, 5311092
Investigational Site Number 1520012 Recruiting
Punta Arenas, Chile, 6210005
Investigational Site Number 1520002 Recruiting
Santiago, Chile, 7500010
Investigational Site Number 1520013 Recruiting
Santiago, Chile, 7500571
Investigational Site Number 1520018 Recruiting
Santiago, Chile, 7500588
Investigational Site Number 1520001 Recruiting
Santiago, Chile, 7500710
Investigational Site Number 1520004 Recruiting
Santiago, Chile, 7500710
Investigational Site Number 1520006 Recruiting
Santiago, Chile, 7500739
Investigational Site Number 1520014 Recruiting
Santiago, Chile, 7591047
Investigational Site Number 1520016 Recruiting
Santiago, Chile, 7650568
Investigational Site Number 1520020 Recruiting
Santiago, Chile, 7980378
Investigational Site Number 1520009 Recruiting
Santiago, Chile, 8053095
Investigational Site Number 1520011 Recruiting
Santiago, Chile, 8207257
Investigational Site Number 1520026 Recruiting
Santiago, Chile, 833-0024
Investigational Site Number 1520010 Recruiting
Santiago, Chile, 8330336
Investigational Site Number 1520007 Recruiting
Santiago, Chile, 8380456
Investigational Site Number 1520017 Recruiting
Santiago, Chile, 8520398
Investigational Site Number 1520022 Recruiting
Santiago, Chile, 8910131
Investigational Site Number 1520021 Recruiting
Santiago, Chile
Investigational Site Number 1520024 Recruiting
Talca, Chile, 71
Investigational Site Number 1520019 Recruiting
Temuco, Chile, 4781156
Investigational Site Number 1520025 Recruiting
Temuco, Chile, 4781173
Investigational Site Number 1520005 Recruiting
Temuco, Chile, 4813299
Investigational Site Number 1520008 Recruiting
Viña Del Mar, Chile, 2520997
China
Investigational Site Number 1560019 Recruiting
Beijing, China, 100034
Investigational Site Number 1560001 Recruiting
Beijing, China, 100037
Investigational Site Number 1560023 Recruiting
Changchun, China, 130021
Investigational Site Number 1560022 Recruiting
Changsha, China, 410013
Investigational Site Number 1560021 Recruiting
Chengdu, China, 610041
Investigational Site Number 1560010 Recruiting
Dalian, China, 116033
Investigational Site Number 1560016 Recruiting
Haikou, China, 570102
Investigational Site Number 1560005 Recruiting
Huai'An, China, 223300
Investigational Site Number 1560009 Recruiting
Jinan, China, 250013
Investigational Site Number 1560031 Recruiting
Nanchang, China, 330006
Investigational Site Number 1560004 Recruiting
Nanjing, China, 210008
Investigational Site Number 1560006 Recruiting
Shanghai, China, 200120
Investigational Site Number 1560036 Recruiting
Shenyang, China, 110016
Investigational Site Number 1560020 Recruiting
Siping, China, 136000
Investigational Site Number 1560025 Recruiting
Suzhou, China, 215004
Investigational Site Number 1560014 Recruiting
Suzhou, China, 215006
Investigational Site Number 1560026 Recruiting
Taizhou, China, 317000
Investigational Site Number 1560028 Recruiting
Tianjin, China, 300121
Investigational Site Number 1560029 Recruiting
Tianjin, China, 300211
Investigational Site Number 1560024 Recruiting
Wuhan, China, 430033
Investigational Site Number 1560008 Recruiting
Zhenjiang, China, 212001
Czechia
Investigational Site Number 2030012 Recruiting
Brno, Czechia, 62500
Investigational Site Number 2030002 Recruiting
Brno, Czechia, 63900
Investigational Site Number 2030021 Recruiting
Broumov, Czechia, 550 01
Investigational Site Number 2030017 Recruiting
Humpolec, Czechia, 396 01
Investigational Site Number 2030014 Recruiting
Liberec, Czechia, 46063
Investigational Site Number 2030007 Recruiting
Marianske Lazne, Czechia, 353 01
Investigational Site Number 2030015 Recruiting
Mestec Kralove, Czechia, 28903
Investigational Site Number 2030009 Recruiting
Plzen, Czechia, 301 00
Investigational Site Number 2030016 Recruiting
Praha 10, Czechia, 10800
Investigational Site Number 2030019 Recruiting
Praha 1, Czechia, 11694
Investigational Site Number 2030006 Recruiting
Praha 2, Czechia, 12808
Investigational Site Number 2030005 Recruiting
Praha 4, Czechia, 14021
Investigational Site Number 2030011 Recruiting
Praha 6, Czechia, 16900
Investigational Site Number 2030018 Recruiting
Praha 8, Czechia, 18100
Investigational Site Number 2030010 Recruiting
Revnice, Czechia, 25230
Investigational Site Number 2030020 Recruiting
Slany, Czechia, 27401
Investigational Site Number 2030001 Recruiting
Trutnov, Czechia, 54101
Investigational Site Number 2030008 Recruiting
Vsetin, Czechia, 75501
Denmark
Investigational Site Number 2080003 Recruiting
Aarhus N, Denmark, 8200
Investigational Site Number 2080005 Recruiting
Aarhus N, Denmark, 8200
Investigational Site Number 2080009 Recruiting
Gentofte, Denmark, 2900
Investigational Site Number 2080004 Recruiting
Herlev, Denmark, 2730
Investigational Site Number 2080008 Recruiting
Hvidovre, Denmark, 2650
Investigational Site Number 2080002 Recruiting
København Nv, Denmark, 2400
Investigational Site Number 2080007 Recruiting
Slagelse, Denmark, 4200
Investigational Site Number 2080006 Recruiting
Svendborg, Denmark, 5700
Estonia
Investigational Site Number 2330003 Recruiting
Tallinn, Estonia, 10138
Investigational Site Number 2330001 Recruiting
Tallinn, Estonia, 13419
Investigational Site Number 2330002 Recruiting
Tartu, Estonia, 51014
Former Yugoslavia
Investigational Site Number 8070003 Recruiting
Skopje, Former Yugoslavia, 1000
Investigational Site Number 8070005 Recruiting
Struga, Former Yugoslavia, 6330
Investigational Site Number 8070001 Recruiting
Tetovo, Former Yugoslavia, 1200
Investigational Site Number 8070004 Recruiting
Tetovo, Former Yugoslavia, 1200
France
Investigational Site Number 2500003 Recruiting
Corbeil-Essonnes, France, 91106
Investigational Site Number 2500002 Recruiting
La Rochelle Cedex, France, 17019
Investigational Site Number 2500001 Recruiting
Paris Cedex 18, France, 75877
Investigational Site Number 2500005 Recruiting
Paris, France, 75010
Investigational Site Number 2500006 Recruiting
Paris, France, 75018
Investigational Site Number 2500004 Recruiting
Toulouse Cedex 9, France, 31059
Investigational Site Number 2500007 Recruiting
Venissieux, France, 69200
Georgia
Investigational Site Number 2680004 Recruiting
Batumi, Georgia, 6010
Investigational Site Number 2680001 Recruiting
Kutaisi, Georgia, 4600
Investigational Site Number 2680002 Recruiting
Tbilisi, Georgia, 0159
Investigational Site Number 2680007 Recruiting
Tbilisi, Georgia, 0159
Investigational Site Number 2680005 Recruiting
Tbilisi, Georgia, 102
Investigational Site Number 2680003 Recruiting
Tbilisi, Georgia, 159
Investigational Site Number 2680006 Recruiting
Tbilisi, Georgia, 159
Germany
Investigational Site Number 2760008 Recruiting
Berlin, Germany, 12351
Investigational Site Number 2760005 Recruiting
Essen, Germany, 45136
Investigational Site Number 2760001 Recruiting
Freiburg, Germany, 79106
Investigational Site Number 2760007 Recruiting
Hamburg, Germany, 22041
Investigational Site Number 2760002 Recruiting
Kassel, Germany, 34121
Investigational Site Number 2760006 Recruiting
Leipzig, Germany, 04103
Investigational Site Number 2760003 Recruiting
Münster, Germany, 48149
Investigational Site Number 2760009 Recruiting
Oldenburg In Holstein, Germany, 23758
Greece
Investigational Site Number 3000001 Recruiting
Athens, Greece, 11527
Investigational Site Number 3000002 Recruiting
Ioannina, Greece, 45500
Investigational Site Number 3000004 Recruiting
Larissa, Greece, 41110
Investigational Site Number 3000003 Recruiting
Pireas, Greece, 18454
Investigational Site Number 3000005 Recruiting
Thessaloniki, Greece, 54629
Guatemala
Investigational Site Number 3200007 Recruiting
Guatemala, Guatemala, 01001
Investigational Site Number 3200013 Recruiting
Guatemala, Guatemala, 01010
Investigational Site Number 3200001 Recruiting
Guatemala, Guatemala, 01014
Investigational Site Number 3200010 Recruiting
Guatemala, Guatemala, 01014
Investigational Site Number 3200002 Recruiting
Guatemala, Guatemala, 1010
Investigational Site Number 3200009 Recruiting
Guatemala, Guatemala, 1010
Investigational Site Number 3200006 Recruiting
Quetzaltenango, Guatemala, 09001
Investigational Site Number 3200014 Recruiting
Quetzaltenango, Guatemala, 09001
Investigational Site Number 3200004 Recruiting
Quetzaltenango, Guatemala, 9011
Hungary
Investigational Site Number 3480017 Recruiting
Budapest, Hungary, 1027
Investigational Site Number 3480004 Recruiting
Budapest, Hungary, 1042
Investigational Site Number 3480011 Recruiting
Budapest, Hungary, 1096
Investigational Site Number 3480001 Recruiting
Budapest, Hungary, 1122
Investigational Site Number 3480010 Recruiting
Budapest, Hungary, 1125
Investigational Site Number 3480012 Recruiting
Budapest, Hungary, 1134
Investigational Site Number 3480016 Recruiting
Budapest, Hungary, 1145
Investigational Site Number 3480018 Recruiting
Budapest, Hungary, 1204
Investigational Site Number 3480006 Recruiting
Békéscsaba, Hungary, 5600
Investigational Site Number 3480002 Recruiting
Debrecen, Hungary, 4032
Investigational Site Number 3480008 Recruiting
Debrecen, Hungary, 4032
Investigational Site Number 3480013 Recruiting
Kaposvár, Hungary, 7400
Investigational Site Number 3480014 Recruiting
Nyíregyháza, Hungary, 4400
Investigational Site Number 3480015 Recruiting
Nyíregyháza, Hungary, 4400
Investigational Site Number 3480003 Recruiting
Szekesfehervar, Hungary, 8000
Investigational Site Number 3480007 Recruiting
Zalaegerszeg, Hungary, 8900
India
Investigational Site Number 3560025 Recruiting
Ahmedabad, India, 380054
Investigational Site Number 3560040 Recruiting
Aurangabad, India, 431003
Investigational Site Number 3560010 Recruiting
Bangalore, India, 560 034
Investigational Site Number 3560026 Recruiting
Bangalore, India, 560 054.
Investigational Site Number 3560005 Recruiting
Belgaum, India, 590010
Investigational Site Number 3560008 Recruiting
Bengaluru, India, 560017
Investigational Site Number 3560022 Recruiting
Chandigarh, India, 160062
Investigational Site Number 3560003 Recruiting
Gurgaon, India, 122001
Investigational Site Number 3560004 Recruiting
Gurgaon, India, 122001
Investigational Site Number 3560018 Recruiting
Hyderabad, India, 500001
Investigational Site Number 3560001 Recruiting
Hyderabad, India, 500012
Investigational Site Number 3560007 Recruiting
Hyderabad, India, 500063
Investigational Site Number 3560002 Recruiting
Jaipur, India, 302017
Investigational Site Number 3560024 Recruiting
Kochi, India
Investigational Site Number 3560016 Recruiting
Kolkata, India, 700027
Investigational Site Number 3560030 Recruiting
Kozhikode, India, 673008
Investigational Site Number 3560006 Recruiting
Ludhiana, India, 141008
Investigational Site Number 3560027 Recruiting
Mangalore, India, 575002
Investigational Site Number 3560028 Recruiting
Mangalore, India, 575018
Investigational Site Number 3560017 Recruiting
Mumbai, India
Investigational Site Number 3560037 Recruiting
Mysore, India, 570015
Investigational Site Number 3560013 Recruiting
Nagpur, India, 440009
Investigational Site Number 3560014 Recruiting
Nagpur, India, 440010
Investigational Site Number 3560021 Recruiting
Nashik, India, 42003
Investigational Site Number 3560041 Recruiting
New Delhi, India, 110 029
Investigational Site Number 3560034 Recruiting
New Delhi, India, 110002
Investigational Site Number 3560019 Recruiting
Pune, India, 411001
Investigational Site Number 3560035 Recruiting
Pune, India, 411004
Investigational Site Number 3560042 Recruiting
Pune, India, 411004
Investigational Site Number 3560038 Recruiting
Pune, India, 411010
Investigational Site Number 3560012 Recruiting
Pune, India, 411019
Investigational Site Number 3560043 Recruiting
Varanasi, India, 221 005
Investigational Site Number 3560020 Recruiting
Vellore, India, 632004
Investigational Site Number 3560015 Recruiting
Wardha, India, 442004
Israel
Investigational Site Number 3760008 Recruiting
Beer Sheva, Israel, 84101
Investigational Site Number 3760005 Recruiting
Haifa, Israel, 31048
Investigational Site Number 3760007 Recruiting
Haifa, Israel, 31096
Investigational Site Number 3760001 Recruiting
Jerusalem, Israel, 91031
Investigational Site Number 3760002 Recruiting
Jerusalem, Israel, 91120
Investigational Site Number 3760004 Recruiting
Nahariya, Israel, 22100
Investigational Site Number 3760003 Recruiting
Tel Aviv, Israel, 64239
Investigational Site Number 3760006 Recruiting
Tel Hashomer, Israel, 52621
Italy
Investigational Site Number 3800006 Recruiting
Catanzaro, Italy, 88100
Investigational Site Number 3800010 Recruiting
Catanzaro, Italy, 88100
Investigational Site Number 3800009 Recruiting
Chieri, Italy, 10023
Investigational Site Number 3800007 Recruiting
Livorno, Italy, 57123
Investigational Site Number 3800002 Recruiting
Milano, Italy, 20132
Investigational Site Number 3800008 Recruiting
Milano, Italy, 20145
Investigational Site Number 3800005 Recruiting
Orbassano, Italy, 10043
Investigational Site Number 3800011 Recruiting
Ravenna, Italy, 48100
Investigational Site Number 3800004 Recruiting
Roma, Italy, 00133
Investigational Site Number 3800001 Recruiting
Verona, Italy, 37126
Korea, Republic of
Investigational Site Number 4100011 Recruiting
Bucheon-Si, Korea, Republic of, 14647
Investigational Site Number 4100005 Recruiting
Busan, Korea, Republic of, 49201
Investigational Site Number 4100007 Recruiting
Gwangju, Korea, Republic of, 61469
Investigational Site Number 4100001 Recruiting
Incheon, Korea, Republic of, 22332
Investigational Site Number 4100002 Recruiting
Seongnam-Si, Korea, Republic of, 13620
Investigational Site Number 4100003 Recruiting
Seoul, Korea, Republic of, 03080
Investigational Site Number 4100009 Recruiting
Seoul, Korea, Republic of, 03181
Investigational Site Number 4100006 Recruiting
Seoul, Korea, Republic of, 03722
Investigational Site Number 4100008 Recruiting
Seoul, Korea, Republic of, 05505
Investigational Site Number 4100004 Recruiting
Seoul, Korea, Republic of, 06351
Investigational Site Number 4100010 Recruiting
Uijeongbu-Si, Korea, Republic of, 11765
Latvia
Investigational Site Number 4280004 Recruiting
Daugavpils, Latvia, LV-5417
Investigational Site Number 4280002 Recruiting
Liepāja, Latvia, LV3414
Investigational Site Number 4280007 Recruiting
Ogre, Latvia, LV-5001
Investigational Site Number 4280006 Recruiting
Riga, Latvia, LV-1002
Investigational Site Number 4280001 Recruiting
Riga, Latvia, LV-1011
Investigational Site Number 4280005 Recruiting
Riga, Latvia, LV-1038
Investigational Site Number 4280003 Recruiting
Sigulda, Latvia, LV-2150
Lithuania
Investigational Site Number 4400006 Recruiting
Kaunas, Lithuania, 49449
Investigational Site Number 4400003 Recruiting
Kaunas, Lithuania, 51270
Investigational Site Number 4400009 Recruiting
Kaunas, Lithuania, LT-50161
Investigational Site Number 4400008 Recruiting
Kedainiai, Lithuania, LT-57164
Investigational Site Number 4400004 Recruiting
Klaipeda, Lithuania, 92111
Investigational Site Number 4400002 Recruiting
Klaipeda, Lithuania, LT-92304
Investigational Site Number 4400007 Recruiting
Ukmerge, Lithuania, 20184
Investigational Site Number 4400005 Recruiting
Utena, Lithuania, LT-28151
Investigational Site Number 4400001 Recruiting
Vilnius, Lithuania, 08661
Mexico
Investigational Site Number 4840009 Recruiting
Actopan, Mexico, 42500
Investigational Site Number 4840013 Recruiting
Aguascalientes, Mexico, 20230
Investigational Site Number 4840019 Recruiting
Aguascalientes, Mexico, 20230
Investigational Site Number 4840018 Recruiting
Cdmx, Mexico, 06760
Investigational Site Number 4840005 Recruiting
Celaya, Mexico, 38000
Investigational Site Number 4840002 Recruiting
Cuernavaca, Mexico, 62250
Investigational Site Number 4840025 Recruiting
Distrito Federal, Mexico, 07760
Investigational Site Number 4840007 Recruiting
Durango, Mexico, 34000
Investigational Site Number 4840023 Recruiting
Durango, Mexico, 34080
Investigational Site Number 4840033 Recruiting
Guadalajara, Mexico, 44150
Investigational Site Number 4840024 Recruiting
Guadalajara, Mexico, 44160
Investigational Site Number 4840003 Recruiting
Guadalajara, Mexico, 44210
Investigational Site Number 4840011 Recruiting
Guadalajara, Mexico, 44210
Investigational Site Number 4840027 Recruiting
Guadalajara, Mexico, 44280
Investigational Site Number 4840004 Recruiting
Guadalajara, Mexico, 44600
Investigational Site Number 4840010 Recruiting
Guadalajara, Mexico, 44650
Investigational Site Number 4840034 Recruiting
Merida, Mexico, 97070
Investigational Site Number 4840021 Recruiting
Monterrey, Mexico, 64020
Investigational Site Number 4840020 Recruiting
Monterrey, Mexico, 64060
Investigational Site Number 4840001 Recruiting
Monterrey, Mexico, 64460
Investigational Site Number 4840028 Recruiting
Mérida, Mexico, 72129
Investigational Site Number 4840014 Recruiting
Queretaro, Mexico, 76000
Investigational Site Number 4840015 Recruiting
Toluca, Mexico, 50130
Investigational Site Number 4840008 Recruiting
Veracruz, Mexico, 91910
Investigational Site Number 4840016 Recruiting
Xalapa, Mexico, 91193
Investigational Site Number 4840026 Recruiting
Zapopan, Mexico, 45116
Netherlands
Investigational Site Number 5280004 Recruiting
Almelo, Netherlands, 7609 PP
Investigational Site Number 5280001 Recruiting
Groningen, Netherlands, 9728 NT
Investigational Site Number 5280003 Recruiting
Hoogeveen, Netherlands, 7909 AA
Investigational Site Number 5280005 Recruiting
Meppel, Netherlands, 7943 KA
Investigational Site Number 5280002 Recruiting
Rotterdam, Netherlands, 3045 PM
New Zealand
Investigational Site Number 5540014 Recruiting
Auckland, New Zealand, 1023
Investigational Site Number 5540006 Recruiting
Birkenhead, New Zealand, 0626
Investigational Site Number 5540009 Recruiting
Birkenhead, New Zealand, 0626
Investigational Site Number 5540002 Recruiting
Christchurch, New Zealand, 8011
Investigational Site Number 5540003 Recruiting
Christchurch, New Zealand
Investigational Site Number 5540012 Recruiting
Christchurch, New Zealand
Investigational Site Number 5540007 Recruiting
Dunedin, New Zealand, 9016
Investigational Site Number 5540016 Recruiting
Hamilton, New Zealand, 3240
Investigational Site Number 5540013 Recruiting
New Plymouth, New Zealand
Investigational Site Number 5540015 Recruiting
Palmerston North, New Zealand, 4414
Investigational Site Number 5540005 Recruiting
Rotorua, New Zealand, 3010
Investigational Site Number 5540010 Recruiting
Takapuna, New Zealand, 1309
Investigational Site Number 5540008 Recruiting
Tauranga, New Zealand, 3001
Investigational Site Number 5540011 Recruiting
Tauranga, New Zealand, 3001
Investigational Site Number 5540004 Recruiting
Wellington, New Zealand, 6021
Norway
Investigational Site Number 5780005 Recruiting
Hamar, Norway, 2317
Investigational Site Number 5780001 Recruiting
Hønefoss, Norway, 3515
Investigational Site Number 5780002 Recruiting
Oslo, Norway, 373
Investigational Site Number 5780003 Recruiting
Oslo, Norway
Investigational Site Number 5780004 Recruiting
Skedsmokorset, Norway, 2020
Peru
Investigational Site Number 6040004 Recruiting
Arequipa, Peru, 04001
Investigational Site Number 6040006 Recruiting
Callao, Peru, CALLAO 02
Investigational Site Number 6040009 Recruiting
Callao, Peru
Investigational Site Number 6040024 Recruiting
Chancay, Peru
Investigational Site Number 6040005 Recruiting
Chiclayo, Peru
Investigational Site Number 6040010 Recruiting
Cuzco, Peru
Investigational Site Number 6040014 Recruiting
Lima Lima, Peru, Lima 01
Investigational Site Number 6040001 Recruiting
Lima, Peru, 09
Investigational Site Number 6040017 Recruiting
Lima, Peru, 33
Investigational Site Number 6040016 Recruiting
Lima, Peru, LIMA 01
Investigational Site Number 6040020 Recruiting
Lima, Peru, LIMA 14
Investigational Site Number 6040013 Recruiting
Lima, Peru, Lima 17
Investigational Site Number 6040023 Recruiting
Lima, Peru, LIMA 27
Investigational Site Number 6040007 Recruiting
Lima, Peru, Lima 29
Investigational Site Number 6040019 Recruiting
Lima, Peru, LIMA 31
Investigational Site Number 6040022 Recruiting
Lima, Peru, LIMA 32
Investigational Site Number 6040012 Recruiting
Lima, Peru, Lima 41
Investigational Site Number 6040025 Recruiting
Lima, Peru
Investigational Site Number 6040011 Recruiting
Piura, Peru, 20000
Investigational Site Number 6040002 Recruiting
Trujillo, Peru
Poland
Investigational Site Number 6160027 Recruiting
Bialystok, Poland, 15-276
Investigational Site Number 6160011 Recruiting
Bialystok, Poland, 15-435
Investigational Site Number 6160029 Recruiting
Bydgoszcz, Poland, 85-079
Investigational Site Number 6160030 Recruiting
Bydgoszcz, Poland, 85-231
Investigational Site Number 6160006 Recruiting
Bydgoszcz, Poland, 85-822
Investigational Site Number 6160018 Recruiting
Bytom, Poland, 41-902
Investigational Site Number 6160002 Recruiting
Czeladz, Poland, 41-250
Investigational Site Number 6160003 Recruiting
Gdynia, Poland, 81-394
Investigational Site Number 6160005 Recruiting
Gdynia, Poland, 81-472
Investigational Site Number 6160008 Recruiting
Grodzisk Mazowiecki, Poland, 05-825
Investigational Site Number 6160031 Recruiting
Grodzisk Mazowiecki, Poland, 05-825
Investigational Site Number 6160023 Recruiting
Katowice, Poland, 40-611
Investigational Site Number 6160026 Recruiting
Katowice, Poland, 40-748
Investigational Site Number 6160022 Recruiting
Kielce, Poland, 25-525
Investigational Site Number 6160019 Recruiting
Krakow, Poland, 31-135
Investigational Site Number 6160024 Recruiting
Krakow, Poland, 31-261
Investigational Site Number 6160010 Recruiting
Krakow, Poland, 31-548
Investigational Site Number 6160016 Recruiting
Lodz, Poland, 90-242
Investigational Site Number 6160015 Recruiting
Lodz, Poland, 90-473
Investigational Site Number 6160013 Recruiting
Lodz, Poland, 91-347
Investigational Site Number 6160007 Recruiting
Lublin, Poland, 20-044
Investigational Site Number 6160033 Recruiting
Poznan, Poland, 60-589
Investigational Site Number 6160021 Recruiting
Pulawy, Poland, 24-100
Investigational Site Number 6160028 Recruiting
Staszow, Poland, 28-200
Investigational Site Number 6160020 Recruiting
Torun, Poland, 87-100
Investigational Site Number 6160014 Recruiting
Warszawa, Poland, 00-631
Investigational Site Number 6160025 Recruiting
Warszawa, Poland, 02-005
Investigational Site Number 6160001 Recruiting
Warszawa, Poland, 02-097
Investigational Site Number 6160004 Recruiting
Warszawa, Poland, 02-507
Investigational Site Number 6160012 Recruiting
Wroclaw, Poland, 52-416
Investigational Site Number 6160017 Recruiting
Zabrze, Poland, 41-800
Investigational Site Number 6160032 Recruiting
Zamosc, Poland, 22-400
Portugal
Investigational Site Number 6200004 Recruiting
Almada, Portugal, 2801-951
Investigational Site Number 6200005 Recruiting
Caldas Da Rainha, Portugal, 2500-176
Investigational Site Number 6200009 Recruiting
Carnaxide, Portugal, 2790-134
Investigational Site Number 6200002 Recruiting
Coimbra, Portugal, 3000-075
Investigational Site Number 6200008 Recruiting
Leiria, Portugal, 2410-197
Investigational Site Number 6200001 Recruiting
Lisboa, Portugal, 1250
Investigational Site Number 6200007 Recruiting
Loures, Portugal, 2674-514
Investigational Site Number 6200003 Recruiting
Porto, Portugal, 4099-001
Puerto Rico
Investigational Site Number 8400122 Recruiting
San Juan, Puerto Rico, 00917
Romania
Investigational Site Number 6420008 Recruiting
Bacau, Romania, 600154
Investigational Site Number 6420005 Recruiting
Baia Mare, Maramures, Romania, 430222
Investigational Site Number 6420009 Recruiting
Brasov, Romania, 500097
Investigational Site Number 6420011 Recruiting
Bucaresti, Romania, 022441
Investigational Site Number 6420013 Recruiting
Bucuresti, Romania, 010507
Investigational Site Number 6420014 Recruiting
Bucuresti, Romania, 010627
Investigational Site Number 6420012 Recruiting
Bucuresti, Romania, 020475
Investigational Site Number 6420002 Recruiting
Craiova, Romania, 200349
Investigational Site Number 6420003 Recruiting
Oradea, Romania, 410159
Investigational Site Number 6420004 Recruiting
Oradea, Romania, 410469
Investigational Site Number 6420010 Recruiting
Ploiesti, Romania, 100561
Investigational Site Number 6420001 Recruiting
Targoviste, Dambovita, Romania, 130095
Investigational Site Number 6420006 Recruiting
Targu Mures, Mures, Romania, 540142
Investigational Site Number 6420007 Recruiting
Targu Mures, Mures, Romania, 540142
Russian Federation
Investigational Site Number 6430028 Recruiting
Kaliningrad, Russian Federation, 236035
Investigational Site Number 6430018 Recruiting
Kazan, Russian Federation, 420101
Investigational Site Number 6430001 Recruiting
Kemerovo, Russian Federation, 650002
Investigational Site Number 6430035 Recruiting
Kemerovo, Russian Federation, 650070
Investigational Site Number 6430025 Recruiting
Krasnodar, Russian Federation, 350042
Investigational Site Number 6430040 Recruiting
Krasnodar, Russian Federation, 350063
Investigational Site Number 6430010 Recruiting
Krasnodar, Russian Federation, 350086
Investigational Site Number 6430015 Recruiting
Moscow, Russian Federation, 101990
Investigational Site Number 6430016 Recruiting
Moscow, Russian Federation, 101990
Investigational Site Number 6430046 Recruiting
Moscow, Russian Federation, 105554
Investigational Site Number 6430003 Recruiting
Moscow, Russian Federation, 117292
Investigational Site Number 6430036 Recruiting
Moscow, Russian Federation, 119192
Investigational Site Number 6430005 Recruiting
Moscow, Russian Federation, 119991
Investigational Site Number 6430039 Recruiting
Moscow, Russian Federation, 119991
Investigational Site Number 6430021 Recruiting
Moscow, Russian Federation, 121309
Investigational Site Number 6430002 Recruiting
Moscow, Russian Federation, 121374
Investigational Site Number 6430020 Recruiting
Moscow, Russian Federation, 125284
Investigational Site Number 6430024 Recruiting
Moscow, Russian Federation, 127644
Investigational Site Number 6430033 Recruiting
Nizhniy Novgorod, Russian Federation, 603005
Investigational Site Number 6430037 Recruiting
Novosibirsk, Russian Federation, 630005
Investigational Site Number 6430034 Recruiting
Novosibirsk, Russian Federation, 630089
Investigational Site Number 6430007 Recruiting
Perm, Russian Federation, 614077
Investigational Site Number 6430019 Recruiting
Rostov-Na-Donu, Russian Federation, 344068
Investigational Site Number 6430012 Recruiting
Saint-Petersburg, Russian Federation, 192242
Investigational Site Number 6430044 Recruiting
Saint-Petersburg, Russian Federation, 197110
Investigational Site Number 6430045 Recruiting
Saint-Petersburg, Russian Federation, 197110
Investigational Site Number 6430043 Recruiting
Saint-Petersburg, Russian Federation, 198205
Investigational Site Number 6430009 Recruiting
Saratov, Russian Federation, 410028
Investigational Site Number 6430013 Recruiting
Saratov, Russian Federation, 410028
Investigational Site Number 6430042 Recruiting
Saratov, Russian Federation, 410039
Investigational Site Number 6430026 Recruiting
Sochi, Russian Federation, 354057
Investigational Site Number 6430027 Recruiting
Sochi, Russian Federation, 354057
Investigational Site Number 6430041 Recruiting
St-Petersburg, Russian Federation, 193312
Investigational Site Number 6430006 Recruiting
St-Petersburg, Russian Federation, 194044
Investigational Site Number 6430008 Recruiting
St-Petersburg, Russian Federation, 194044
Investigational Site Number 6430030 Recruiting
St-Petersburg, Russian Federation, 194044
Investigational Site Number 6430014 Recruiting
St-Petersburg, Russian Federation, 197341
Investigational Site Number 6430017 Recruiting
St-Petersburg, Russian Federation, 197341
Investigational Site Number 6430004 Recruiting
St-Petersburg, Russian Federation, 199106
Investigational Site Number 6430011 Recruiting
Tomsk, Russian Federation, 634012
Investigational Site Number 6430038 Recruiting
Tomsk, Russian Federation, 634050
Investigational Site Number 6430032 Recruiting
Tyumen, Russian Federation, 625000
Investigational Site Number 6430023 Recruiting
Vladimir, Russian Federation, 600020
Investigational Site Number 6430022 Recruiting
Vladimir, Russian Federation, 600023
Investigational Site Number 6430031 Recruiting
Yaroslavl, Russian Federation, 150002
Serbia
Investigational Site Number 6880002 Recruiting
Belgrade, Serbia, 11000
Investigational Site Number 6880003 Recruiting
Belgrade, Serbia, 11000
Investigational Site Number 6880004 Recruiting
Belgrade, Serbia, 11000
Investigational Site Number 6880005 Recruiting
Kragujevac, Serbia, 34000
Investigational Site Number 6880001 Recruiting
Nis, Serbia, 18000
Investigational Site Number 6880006 Recruiting
Nis, Serbia, 18000
Investigational Site Number 6880007 Recruiting
Nis, Serbia, 18000
Slovakia
Investigational Site Number 7030006 Recruiting
Bardejov, Slovakia, 085 01
Investigational Site Number 7030012 Recruiting
Bratislava, Slovakia, 813 69
Investigational Site Number 7030011 Recruiting
Kosice, Slovakia, 040 01
Investigational Site Number 7030001 Recruiting
Lubochna, Slovakia, 034 91
Investigational Site Number 7030008 Recruiting
Lucenec, Slovakia, 984 39
Investigational Site Number 7030009 Recruiting
Lucenec, Slovakia, 98401
Investigational Site Number 7030010 Recruiting
Lucenec, Slovakia, 98401
Investigational Site Number 7030004 Recruiting
Moldava Nad Bodvou, Slovakia, 04525
Investigational Site Number 7030013 Recruiting
Presov, Slovakia, 080 01
Investigational Site Number 7030003 Recruiting
Roznava, Slovakia, 04801
Investigational Site Number 7030002 Recruiting
Sabinov, Slovakia, 083 01
Investigational Site Number 7030007 Recruiting
Svidnik, Slovakia, 089 01
South Africa
Investigational Site Number 7100005 Recruiting
Brits, South Africa, 0250
Investigational Site Number 7100009 Recruiting
Cape Town, South Africa, 7530
Investigational Site Number 7100006 Recruiting
Cape Town, South Africa, 7570
Investigational Site Number 7100001 Recruiting
Parow, South Africa, 7500
Investigational Site Number 7100012 Recruiting
Pinelands, South Africa, 7405
Investigational Site Number 7100011 Recruiting
Pretoria, South Africa, 0002
Investigational Site Number 7100014 Recruiting
Pretoria, South Africa, 0083
Investigational Site Number 7100008 Recruiting
Pretoria, South Africa, 0157
Investigational Site Number 7100010 Recruiting
Rivonia, South Africa, 2128
Investigational Site Number 7100007 Recruiting
Soweto, South Africa, 1818
Investigational Site Number 7100002 Recruiting
Umkomaas, South Africa, 4170
Investigational Site Number 7100013 Recruiting
Vosloorus, South Africa, 1475
Investigational Site Number 7100003 Recruiting
Western Cape, South Africa, 7130
Spain
Investigational Site Number 7240003 Recruiting
Almería, Spain, 04120
Investigational Site Number 7240014 Recruiting
Barcelona, Spain, 08035
Investigational Site Number 7240011 Recruiting
Barcelona, Spain, 08041
Investigational Site Number 7240009 Recruiting
Córdoba, Spain, 14004
Investigational Site Number 7240024 Recruiting
El Puerto De Santa Maria, Spain, 11500
Investigational Site Number 7240016 Recruiting
Granada, Spain, 18016
Investigational Site Number 7240015 Recruiting
La Coruña, Spain, 15006
Investigational Site Number 7240001 Recruiting
Madrid, Spain, 28023
Investigational Site Number 7240019 Recruiting
Madrid, Spain, 28034
Investigational Site Number 7240006 Recruiting
Madrid, Spain, 28040
Investigational Site Number 7240010 Recruiting
Madrid, Spain, 28046
Investigational Site Number 7240020 Recruiting
Madrid, Spain, 28046
Investigational Site Number 7240025 Recruiting
Sabadell, Spain, 08208
Investigational Site Number 7240023 Recruiting
Sanlúcar De Barrameda, Spain, 11540
Investigational Site Number 7240013 Recruiting
Santa Cruz De Tenerife, Spain, 38320
Investigational Site Number 7240007 Recruiting
Santiago De Compostela, Spain, 15706
Investigational Site Number 7240026 Recruiting
Sevilla, Spain, 41014
Investigational Site Number 7240012 Recruiting
Sevilla, Spain, 41071
Investigational Site Number 7240004 Recruiting
Valencia, Spain, 46010
Investigational Site Number 7240002 Recruiting
Vigo, Spain, 36312
Investigational Site Number 7240022 Recruiting
Villamartín, Spain, 11650
Investigational Site Number 7240008 Recruiting
Zaragoza, Spain, 50009
Sweden
Investigational Site Number 7520007 Recruiting
Falun, Sweden, 791 82
Investigational Site Number 7520005 Recruiting
Lund, Sweden, 221 85
Investigational Site Number 7520004 Recruiting
Mölndal, Sweden, 43180
Investigational Site Number 7520003 Recruiting
Rättvik, Sweden, 79530
Investigational Site Number 7520008 Recruiting
Stockholm, Sweden, 112 21
Investigational Site Number 7520002 Recruiting
Stockholm, Sweden, 118 83
Investigational Site Number 7520006 Recruiting
Stockholm, Sweden, 14186
Investigational Site Number 7520001 Recruiting
Uppsala, Sweden, 751 85
Switzerland
Investigational Site Number 7560001 Recruiting
Olten, Switzerland, 4600
Investigational Site Number 7560002 Recruiting
Zollikerberg, Switzerland, 8125
Taiwan
Investigational Site Number 1580005 Recruiting
Hsinchu, Taiwan, 30071
Investigational Site Number 1580008 Recruiting
Kaohsiung, Taiwan, 807
Investigational Site Number 1580004 Recruiting
Linkou, Taiwan
Investigational Site Number 1580006 Recruiting
Taichung, Taiwan, 40447
Investigational Site Number 1580002 Recruiting
Tainan, Taiwan, 704
Investigational Site Number 1580007 Recruiting
Tainan, Taiwan, 710
Investigational Site Number 1580003 Recruiting
Taipei, Taiwan, 100
Investigational Site Number 1580001 Recruiting
Taipei, Taiwan, 112
Turkey
Investigational Site Number 7920018 Recruiting
Antalya, Turkey, 07070
Investigational Site Number 7920010 Recruiting
Aydın, Turkey, 09100
Investigational Site Number 7920004 Recruiting
Corum, Turkey, 19200
Investigational Site Number 7920016 Recruiting
Gaziantep, Turkey, 27310
Investigational Site Number 7920011 Recruiting
Istanbul, Turkey, 34034
Investigational Site Number 7920009 Recruiting
Istanbul, Turkey, 34390
Investigational Site Number 7920001 Recruiting
Istanbul, Turkey
Investigational Site Number 7920007 Completed
Istanbul, Turkey
Investigational Site Number 7920017 Recruiting
Istanbul, Turkey
Investigational Site Number 7920003 Recruiting
Izmir, Turkey, 35340
Investigational Site Number 7920013 Recruiting
Kayseri, Turkey, 38039
Investigational Site Number 7920014 Recruiting
Kocaeli, Turkey, 41380
Investigational Site Number 7920005 Recruiting
Kutahya, Turkey
Investigational Site Number 7920015 Recruiting
Malatya, Turkey
Investigational Site Number 7920008 Recruiting
Mersin, Turkey, 33169
Investigational Site Number 7920002 Recruiting
Sivas, Turkey, 58140
Ukraine
Investigational Site Number 8040020 Recruiting
Dnipro, Ukraine, 49005
Investigational Site Number 8040006 Recruiting
Dnipro, Ukraine, 49600
Investigational Site Number 8040009 Recruiting
Ivano-Frankivsk, Ukraine, 76000
Investigational Site Number 8040012 Recruiting
Ivano-Frankivsk, Ukraine, 76018
Investigational Site Number 8040021 Recruiting
Kharkiv, Ukraine, 61039
Investigational Site Number 8040011 Recruiting
Kharkiv, Ukraine, 61058
Investigational Site Number 8040008 Recruiting
Kharkiv, Ukraine, 61166
Investigational Site Number 8040002 Recruiting
Kiev, Ukraine, 02091
Investigational Site Number 8040024 Recruiting
Kiev, Ukraine, 02660
Investigational Site Number 8040003 Recruiting
Kyiv, Ukraine, 03049
Investigational Site Number 8040015 Recruiting
Kyiv, Ukraine, 03115
Investigational Site Number 8040019 Recruiting
Kyiv, Ukraine, 04050
Investigational Site Number 8040010 Recruiting
Kyiv, Ukraine, 04114
Investigational Site Number 8040026 Recruiting
Kyiv, Ukraine, 04114
Investigational Site Number 8040023 Recruiting
Lutsk, Ukraine, 43005
Investigational Site Number 8040025 Recruiting
Lutsk, Ukraine, 43024
Investigational Site Number 8040022 Recruiting
Lviv, Ukraine, 79011
Investigational Site Number 8040001 Recruiting
Ternopil, Ukraine, 46000
Investigational Site Number 8040016 Recruiting
Vinnitsya, Ukraine, 21018
Investigational Site Number 8040007 Recruiting
Vinnitsya, Ukraine, 21100
Investigational Site Number 8040004 Recruiting
Vinnytsya, Ukraine, 21001
Investigational Site Number 8040018 Recruiting
Zhytomyr, Ukraine
United Kingdom
Investigational Site Number 8260003 Recruiting
Belfast, United Kingdom, BT12 6BA
Investigational Site Number 8260007 Recruiting
Chippenham, United Kingdom, SN14 6GT
Investigational Site Number 8260009 Recruiting
Davyhulme, Manchester, United Kingdom, M41 5SL
Investigational Site Number 8260010 Recruiting
Glasgow, United Kingdom, G21 3UW
Investigational Site Number 8260004 Recruiting
Hayle, United Kingdom, TR27 5DT
Investigational Site Number 8260011 Recruiting
Inverness, United Kingdom, IV2 3UJ
Investigational Site Number 8260002 Recruiting
Ipswich, United Kingdom, IP4 5PD
Investigational Site Number 8260006 Recruiting
Maidstone, United Kingdom, ME16 9QQ
Investigational Site Number 8260001 Recruiting
Swansea, United Kingdom, SA2 8PP
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03315143     History of Changes
Other Study ID Numbers: EFC14875
2017-002644-32
U1111-1187-8703 ( Other Identifier: UTN )
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs