AzTrials
AzTrials

Heart FailurePhase 3SCOREDNCT03315143

Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

A Phase 3 study testing Sotagliflozin in people with Heart Failure and Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 754 sites in 45 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sotagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10,584 participants
Where
754 sitesin 45 countries
Study dates
19 Dec 2017to 8 Jul 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) ≥7%.
  • Estimated glomerular filtration rate (eGFR) ≥25 and ≤60 milliliter/minute (mL/min)/1.73 square meter (m^2).
  • 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.

Who cannot join

  • 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 participant's potential participation in a clinical trial.

Trial locations and contacts

754 sites in 45 countries.

754 sites in 45 countries

United States119 sites

  • Investigational Site Number 8400101

    Albany, New York, 12206

  • Investigational Site Number 8400064

    Anderson, South Carolina, 29621

  • Investigational Site Number 8400114

    Arlington, Texas, 76015

  • Investigational Site Number 8400085

    Arlington Heights, Illinois, 60005

  • Investigational Site Number 8400123

    Atlanta, Georgia, 30303

  • Investigational Site Number 8400080

    Bangor, Maine, 04401

  • Investigational Site Number 8400047

    Beaver, Pennsylvania, 15009

  • Investigational Site Number 8400109

    Bend, Oregon, 97702

  • Investigational Site Number 8400093

    Bennington, Vermont, 05201

  • Investigational Site Number 8400039

    Beverly Hills, California, 90211

  • Investigational Site Number 8400017

    Birmingham, Alabama, 35205

  • Investigational Site Number 8400065

    Bountiful, Utah, 84010-7717

  • Investigational Site Number 8400095

    Bradenton, Florida, 34209

  • Investigational Site Number 8400104

    Chicago, Illinois, 60611

  • Investigational Site Number 8400027

    Chicago, Illinois, 60612

  • Investigational Site Number 8400124

    Chicago, Illinois, 60612

  • Investigational Site Number 8400001

    Chicago, Illinois, 60616

  • Investigational Site Number 8400038

    Cincinnati, Ohio, 45219

  • Investigational Site Number 8400007

    Cincinnati, Ohio, 45241

  • Investigational Site Number 8400090

    Clearwater, Florida, 33756

  • Investigational Site Number 8400121

    Clearwater, Florida, 33756

  • Investigational Site Number 8400015

    Columbus, Ohio, 43210

  • Investigational Site Number 8400042

    Concord, California, 94520

  • Investigational Site Number 8400049

    Cooper City, Florida, 33024

  • Investigational Site Number 8400067

    Corpus Christi, Texas, 78814

  • Investigational Site Number 8400052

    Crystal Lake, Illinois, 60012

  • Investigational Site Number 8400082

    Dallas, Texas, 75231

  • Investigational Site Number 8400133

    Danville, Virginia, 24541-2834

  • Investigational Site Number 8400003

    Des Moines, Iowa, 50314

  • Investigational Site Number 8400022

    El Paso, Texas, 79935

  • Investigational Site Number 8400054

    Fairfax, Virginia, 22039

  • Investigational Site Number 8400132

    Falls Church, Virginia, 22044

  • Investigational Site Number 8400072

    Fargo, North Dakota, 58103

  • Investigational Site Number 8400083

    Federal Way, Washington, 98003

  • Investigational Site Number 8400002

    Flint, Michigan, 48504

  • Investigational Site Number 8400069

    Flint, Michigan, 48532-3447

  • Investigational Site Number 8400089

    Fresno, California, 93720

  • Investigational Site Number 8400019

    Greensburg, Pennsylvania, 15601

  • Investigational Site Number 8400079

    Greenville, North Carolina, 27834-5704

  • Investigational Site Number 8400030

    Greer, South Carolina, 29651

  • Investigational Site Number 8400092

    Hialeah, Florida, 33012

  • Investigational Site Number 8400026

    Hollywood, Florida, 33024

  • Investigational Site Number 8400033

    Honolulu, Hawaii, 96814

  • Investigational Site Number 8400099

    Houston, Texas, 77043

  • Investigational Site Number 8400103

    Houston, Texas, 77070

  • Investigational Site Number 8400006

    Huntington Park, California, 90255

  • Investigational Site Number 8400097

    Indiana, Pennsylvania, 15701-3578

  • Investigational Site Number 8400134

    Jacksonville, Florida, 32204

  • Investigational Site Number 8400055

    Jacksonville, Florida, 32207-4966

  • Investigational Site Number 8400056

    Jacksonville, Florida, 32216

  • Investigational Site Number 8400031

    Jacksonville, Florida, 32277

  • Investigational Site Number 8400066

    Kansas City, Missouri, 64111

  • Investigational Site Number 8400086

    Katy, Texas, 77450

  • Investigational Site Number 8400009

    Las Vegas, Nevada, 89148

  • Investigational Site Number 8400061

    Laurelton, New York, 11413

  • Investigational Site Number 8400032

    Levittown, Pennsylvania, 19056-2404

  • Investigational Site Number 8400071

    Little Rock, Arkansas, 72211

  • Investigational Site Number 8400036

    Long Beach, California, 90807

  • Investigational Site Number 8400113

    Lorain, Ohio, 44053

  • Investigational Site Number 8400073

    Los Angeles, California, 90017

  • Investigational Site Number 8400084

    Los Angeles, California, 90022-4302

  • Investigational Site Number 8400035

    Los Gatos, California, 95032

  • Investigational Site Number 8400041

    Louisville, Kentucky, 40213

  • Investigational Site Number 8400037

    Maitland, Florida, 32751

  • Investigational Site Number 8400034

    Manassas, Virginia, 20110

  • Investigational Site Number 8400040

    Memphis, Tennessee, 38163

  • Investigational Site Number 8400011

    Mentor, Ohio, 44060

  • Investigational Site Number 8400004

    Mesa, Arizona, 85206

  • Investigational Site Number 8400059

    Mesa, Arizona, 85210

  • Investigational Site Number 8400100

    Mesquite, Texas, 75150

  • Investigational Site Number 8400078

    Miami, Florida, 33126

  • Investigational Site Number 8400117

    Miami, Florida, 33135

  • Investigational Site Number 8400119

    Miami, Florida, 33135

  • Investigational Site Number 8400118

    Miami, Florida, 33165

  • Investigational Site Number 8400105

    Miami, Florida, 33174

  • Investigational Site Number 8400120

    Miami, Florida, 33176

  • Investigational Site Number 8400125

    Michigan City, Indiana, 46360

  • Investigational Site Number 8400020

    Morehead City, North Carolina, 28557

  • Investigational Site Number 8400048

    Morehead City, North Carolina, 28557

  • Investigational Site Number 8400010

    Morganton, North Carolina, 28655

  • Investigational Site Number 8400029

    Myrtle Beach, South Carolina, 29572

  • Investigational Site Number 8400046

    New York, New York, 10029-6501

  • Investigational Site Number 8400050

    Norfolk, Virginia, 23510

  • Investigational Site Number 8400088

    North Miami Beach, Florida, 33162

  • Investigational Site Number 8400043

    Northridge, California, 91325

  • Investigational Site Number 8400131

    Ogden, Utah, 84405

  • Investigational Site Number 8400045

    Omaha, Nebraska, 68198-4100

  • Investigational Site Number 8400106

    Opa-locka, Florida, 33054

  • Investigational Site Number 8400063

    Ormond Beach, Florida, 32174

  • Investigational Site Number 8400087

    Palm Harbor, Florida, 34684-3609

  • Investigational Site Number 8400021

    Peoria, Arizona, 85381

  • Investigational Site Number 8400053

    Philadelphia, Pennsylvania, 19107

  • Investigational Site Number 8400012

    Pittsburgh, Pennsylvania, 15212

  • Investigational Site Number 8400094

    Plano, Texas, 75093

  • Investigational Site Number 8400044

    Richmond, Virginia, 23235

  • Investigational Site Number 8400111

    Richmond, Virginia, 23249

  • Investigational Site Number 8400112

    Rosedale, New York, 11422

  • Investigational Site Number 8400076

    Roswell, Georgia, 30076

  • Investigational Site Number 8400025

    Sacramento, California, 95821

  • Investigational Site Number 8400023

    Saint Cloud, Minnesota, 56303

  • Investigational Site Number 8400116

    San Antonio, Texas, 78224

  • Investigational Site Number 8400018

    San Dimas, California, 91713

  • Investigational Site Number 8400096

    Sheffield, Alabama, 35660

  • Investigational Site Number 8400062

    Smithtown, New York, 11787

  • Investigational Site Number 8400060

    South Burlington, Vermont, 05403

  • Investigational Site Number 8400068

    Spokane, Washington, 99207

  • Investigational Site Number 8400108

    Spring Hill, Florida, 34609

  • Investigational Site Number 8400028

    Springfield, Illinois, 62711

  • Investigational Site Number 8400024

    St Louis, Missouri, 63136

  • Investigational Site Number 8400058

    St. Petersburg, Florida, 33713

  • Investigational Site Number 8400014

    Surprise, Arizona, 85374

  • Investigational Site Number 8400051

    Tampa, Florida, 33624

  • Investigational Site Number 8400070

    Temecula, California, 92591

  • Investigational Site Number 8400081

    Topeka, Kansas, 66606

  • Investigational Site Number 8400016

    Troy, Michigan, 48098

  • Investigational Site Number 8400098

    Valparaiso, Indiana, 46383

  • Investigational Site Number 8400091

    Waco, Texas, 76710

  • Investigational Site Number 8400130

    Washington, Missouri, 63090

  • Investigational Site Number 8400013

    Waterbury, Connecticut, 06708

Other trials in United States

Russia45 sites

  • Investigational Site Number 6430028

    Kaliningrad, 236035

  • Investigational Site Number 6430018

    Kazan', 420101

  • Investigational Site Number 6430001

    Kemerovo, 650002

  • Investigational Site Number 6430035

    Kemerovo, 650070

  • Investigational Site Number 6430025

    Krasnodar, 350042

  • Investigational Site Number 6430040

    Krasnodar, 350063

  • Investigational Site Number 6430010

    Krasnodar, 350086

  • Investigational Site Number 6430015

    Moscow, 101990

  • Investigational Site Number 6430016

    Moscow, 101990

  • Investigational Site Number 6430046

    Moscow, 105554

  • Investigational Site Number 6430003

    Moscow, 117292

  • Investigational Site Number 6430036

    Moscow, 119192

  • Investigational Site Number 6430005

    Moscow, 119991

  • Investigational Site Number 6430039

    Moscow, 119991

  • Investigational Site Number 6430021

    Moscow, 121309

  • Investigational Site Number 6430002

    Moscow, 121374

  • Investigational Site Number 6430020

    Moscow, 125284

  • Investigational Site Number 6430024

    Moscow, 127644

  • Investigational Site Number 6430033

    Nizhny Novgorod, 603005

  • Investigational Site Number 6430037

    Novosibirsk, 630005

  • Investigational Site Number 6430034

    Novosibirsk, 630089

  • Investigational Site Number 6430007

    Perm, 614077

  • Investigational Site Number 6430019

    Rostov-on-Don, 344068

  • Investigational Site Number 6430012

    Saint Petersburg, 192242

  • Investigational Site Number 6430041

    Saint Petersburg, 193312

  • Investigational Site Number 6430006

    Saint Petersburg, 194044

  • Investigational Site Number 6430008

    Saint Petersburg, 194044

  • Investigational Site Number 6430030

    Saint Petersburg, 194044

  • Investigational Site Number 6430044

    Saint Petersburg, 197110

  • Investigational Site Number 6430045

    Saint Petersburg, 197110

  • Investigational Site Number 6430014

    Saint Petersburg, 197341

  • Investigational Site Number 6430017

    Saint Petersburg, 197341

  • Investigational Site Number 6430043

    Saint Petersburg, 198205

  • Investigational Site Number 6430004

    Saint Petersburg, 199106

  • Investigational Site Number 6430009

    Saratov, 410028

  • Investigational Site Number 6430013

    Saratov, 410028

  • Investigational Site Number 6430042

    Saratov, 410039

  • Investigational Site Number 6430026

    Sochi, 354057

  • Investigational Site Number 6430027

    Sochi, 354057

  • Investigational Site Number 6430011

    Tomsk, 634012

  • Investigational Site Number 6430038

    Tomsk, 634050

  • Investigational Site Number 6430032

    Tyumen, 625000

  • Investigational Site Number 6430023

    Vladimir, 600020

  • Investigational Site Number 6430022

    Vladimir, 600023

  • Investigational Site Number 6430031

    Yaroslavl, 150002

Other trials in Russia

India34 sites

  • Investigational Site Number 3560025

    Ahmedabad, 380060

  • Investigational Site Number 3560010

    Bangalore, 560 034

  • Investigational Site Number 3560026

    Bangalore, 560 054.

  • Investigational Site Number 3560005

    Belagavi, 590010

  • Investigational Site Number 3560008

    Bengaluru, 560017

  • Investigational Site Number 3560022

    Chandigarh, 160062

  • Investigational Site Number 3560040

    Chhatrapati Sambhajinagar, 431003

  • Investigational Site Number 3560003

    Gūrgaon, 122001

  • Investigational Site Number 3560004

    Gūrgaon, 122001

  • Investigational Site Number 3560018

    Hyderabad, 500001

  • Investigational Site Number 3560001

    Hyderabad, 500012

  • Investigational Site Number 3560007

    Hyderabad, 500063

  • Investigational Site Number 3560002

    Jaipur, 302017

  • Investigational Site Number 3560024

    Kochi

  • Investigational Site Number 3560016

    Kolkata, 700027

  • Investigational Site Number 3560030

    Kozhikode, 673008

  • Investigational Site Number 3560006

    Ludhiana, 141008

  • Investigational Site Number 3560027

    Mangalore, 575002

  • Investigational Site Number 3560028

    Mangalore, 575018

  • Investigational Site Number 3560017

    Mumbai

  • Investigational Site Number 3560037

    Mysore, 570015

  • Investigational Site Number 3560013

    Nagpur, 440009

  • Investigational Site Number 3560014

    Nagpur, 440010

  • Investigational Site Number 3560021

    Nashik, 42003

  • Investigational Site Number 3560041

    New Delhi, 110 029

  • Investigational Site Number 3560034

    New Delhi, 110002

  • Investigational Site Number 3560019

    Pune, 411001

  • Investigational Site Number 3560035

    Pune, 411004

  • Investigational Site Number 3560042

    Pune, 411004

  • Investigational Site Number 3560038

    Pune, 411010

  • Investigational Site Number 3560012

    Pune, 411019

  • Investigational Site Number 3560043

    Varanasi, 221 005

  • Investigational Site Number 3560020

    Vellore, 632004

  • Investigational Site Number 3560015

    Wardha, 442004

Other trials in India

China33 sites

  • Investigational Site Number 1560019

    Beijing, 100034

  • Investigational Site Number 1560001

    Beijing, 100037

  • Investigational Site Number 1560002

    Beijing, 100044

  • Investigational Site Number 1560003

    Beijing, 100730

  • Investigational Site Number 1560032

    Beijing, 100730

  • Investigational Site Number 1560012

    Changchun, 130021

  • Investigational Site Number 1560023

    Changchun, 130021

  • Investigational Site Number 1560034

    Changchun, 130033

  • Investigational Site Number 1560022

    Changsha, 410013

  • Investigational Site Number 1560021

    Chengdu, 610041

  • Investigational Site Number 1560018

    Dalian, 116011

  • Investigational Site Number 1560010

    Dalian, 116033

  • Investigational Site Number 1560007

    Guangzhou, 510080

  • Investigational Site Number 1560016

    Haikou, 570102

  • Investigational Site Number 1560033

    Hengyang, 421001

  • Investigational Site Number 1560038

    Hohhot, 010020

  • Investigational Site Number 1560005

    Huai'an, 223300

  • Investigational Site Number 1560009

    Jinan, 250013

  • Investigational Site Number 1560037

    Jining

  • Investigational Site Number 1560031

    Nanchang, 330006

  • Investigational Site Number 1560004

    Nanjing, 210008

  • Investigational Site Number 1560006

    Shanghai, 200120

  • Investigational Site Number 1560036

    Shenyang, 110016

  • Investigational Site Number 1560020

    Siping, 136000

  • Investigational Site Number 1560025

    Suzhou, 215004

  • Investigational Site Number 1560014

    Suzhou, 215006

  • Investigational Site Number 1560026

    Taizhou, 317000

  • Investigational Site Number 1560028

    Tianjin, 300121

  • Investigational Site Number 1560029

    Tianjin, 300211

  • Investigational Site Number 1560024

    Wuhan, 430033

  • Investigational Site Number 1560027

    Xi'an, 710061

  • Investigational Site Number 1560035

    Xinxiang, 453000

  • Investigational Site Number 1560008

    Zhenjiang, 212001

Other trials in China

Poland32 sites

  • Investigational Site Number 6160027

    Bialystok, 15-276

  • Investigational Site Number 6160011

    Bialystok, 15-435

  • Investigational Site Number 6160029

    Bydgoszcz, 85-079

  • Investigational Site Number 6160030

    Bydgoszcz, 85-231

  • Investigational Site Number 6160006

    Bydgoszcz, 85-822

  • Investigational Site Number 6160018

    Bytom, 41-902

  • Investigational Site Number 6160002

    Czeladź, 41-250

  • Investigational Site Number 6160003

    Gdynia, 81-394

  • Investigational Site Number 6160005

    Gdynia, 81-472

  • Investigational Site Number 6160008

    Grodzisk Mazowiecki, 05-825

  • Investigational Site Number 6160031

    Grodzisk Mazowiecki, 05-825

  • Investigational Site Number 6160023

    Katowice, 40-611

  • Investigational Site Number 6160026

    Katowice, 40-748

  • Investigational Site Number 6160022

    Kielce, 25-525

  • Investigational Site Number 6160019

    Krakow, 31-135

  • Investigational Site Number 6160024

    Krakow, 31-261

  • Investigational Site Number 6160010

    Krakow, 31-548

  • Investigational Site Number 6160016

    Lodz, 90-242

  • Investigational Site Number 6160013

    Lodz, 91-347

  • Investigational Site Number 6160015

    Lodz

  • Investigational Site Number 6160007

    Lublin, 20-044

  • Investigational Site Number 6160033

    Poznan, 60-589

  • Investigational Site Number 6160021

    Puławy, 24-100

  • Investigational Site Number 6160028

    Staszów, 28-200

  • Investigational Site Number 6160020

    Torun, 87-100

  • Investigational Site Number 6160014

    Warsaw, 00-631

  • Investigational Site Number 6160025

    Warsaw, 02-005

  • Investigational Site Number 6160001

    Warsaw, 02-097

  • Investigational Site Number 6160004

    Warsaw, 02-507

  • Investigational Site Number 6160012

    Wroclaw, 52-416

  • Investigational Site Number 6160017

    Zabrze, 41-800

  • Investigational Site Number 6160032

    Zamość, 22-400

Other trials in Poland

Canada30 sites

  • Investigational Site Number 1240002

    Brampton, L6S0C6

  • Investigational Site Number 1240013

    Burlington, L7M 4Y1

  • Investigational Site Number 1240021

    Calgary, T2T 5C7

  • Investigational Site Number 1240005

    Calgary, T2V 4J2

  • Investigational Site Number 1240029

    Concord, L4K 4M2

  • Investigational Site Number 1240004

    Edmonton, T5A 4L8

  • Investigational Site Number 1240010

    Edmonton, T6H 2L4

  • Investigational Site Number 1240008

    Greater Sudbury, P3E 4H5

  • Investigational Site Number 1240027

    Halifax, B3H 2Y9

  • Investigational Site Number 1240023

    Hamilton, L8N 3Z5

  • Investigational Site Number 1240011

    London, N6A 4V2

  • Investigational Site Number 1240019

    Montreal, H1T 1C8

  • Investigational Site Number 1240017

    Montreal, H4A 2C6

  • Investigational Site Number 1240018

    Montreal, H4N 2W2

  • Investigational Site Number 1240007

    Newmarket, L3Y 5G8

  • Investigational Site Number 1240026

    Oshawa, L1G 2B9

  • Investigational Site Number 1240016

    Oshawa, L1J 2K1

  • Investigational Site Number 1240006

    Ottawa, K1H7W9

  • Investigational Site Number 1240022

    Québec, G1G 3Z4

  • Investigational Site Number 1240025

    Québec, G1V 4G5

  • Investigational Site Number 1240014

    Québec, G1V 4W2

  • Investigational Site Number 1240003

    Québec, G1W-4R4

  • Investigational Site Number 1240034

    Saint-Charles-Borromée, J6E 6J2

  • Investigational Site Number 1240032

    Saint-Marc-des-Carrieres, G0A 4B0

  • Investigational Site Number 1240033

    St. John's, A1B 3V6

  • Investigational Site Number 1240031

    Surrey, V3V 0C6

  • Investigational Site Number 1240028

    Toronto, M6G 1M2

  • Investigational Site Number 1240015

    Trois-Rivières, G8Z 3R9

  • Investigational Site Number 1240001

    Vancouver, V5Y 3W2

  • Investigational Site Number 1240030

    Victoria, V8R 1B2

Other trials in Canada

Argentina29 sites

  • Investigational Site Number 0320016

    Buenos Aires

  • Investigational Site Number 0320029

    Buenos Aires

  • Investigational Site Number 0320017

    Caba, 1120

  • Investigational Site Number 0320002

    Caba, C1093AAS

  • Investigational Site Number 0320004

    Caba, C1118AAE

  • Investigational Site Number 0320018

    Caba, C1119ACN

  • Investigational Site Number 0320025

    Caba, C1128AAF

  • Investigational Site Number 0320019

    Caba

  • Investigational Site Number 0320027

    Capital Federal, C1056ABJ

  • Investigational Site Number 0320015

    Capital Federal, C1179AAB

  • Investigational Site Number 0320014

    Ciudad Autonoma de Bs.As, C1428DCO

  • Investigational Site Number 0320023

    Ciudad Autonoma de Buenos Aire, C1204AAD

  • Investigational Site Number 0320009

    Ciudadela, B1702BML

  • Investigational Site Number 0320001

    Córdoba, X5000AAX

  • Investigational Site Number 0320008

    Coronel Suárez, B7540GHD

  • Investigational Site Number 0320011

    Corrientes, W3400AMZ

  • Investigational Site Number 0320028

    La Plata, B1900AXI

  • Investigational Site Number 0320006

    La Plata, B1906ESC

  • Investigational Site Number 0320024

    Mar del Plata, B7600FZN

  • Investigational Site Number 0320003

    Mar del Plata, B7600

  • Investigational Site Number 0320020

    Merlo, B1722COV

  • Investigational Site Number 0320007

    Ramos Mejía, B1704ETD

  • Investigational Site Number 0320030

    Rosario, S2000CVD

  • Investigational Site Number 0320026

    Rosario, S2000DEJ

  • Investigational Site Number 0320012

    Salta, 4400

  • Investigational Site Number 0320021

    San Miguel de Tucumán, T4000ICL

  • Investigational Site Number 0320013

    Santa Fe, S3000FWO

  • Investigational Site Number 0320022

    Temperley, 1842

  • Investigational Site Number 0320005

    Villa María, X5900JKA

Other trials in Argentina

Mexico27 sites

  • Investigational Site Number 4840009

    Actopan, 42500

  • Investigational Site Number 4840013

    Aguascalientes, 20230

  • Investigational Site Number 4840019

    Aguascalientes, 20230

  • Investigational Site Number 4840005

    Celaya, 38000

  • Investigational Site Number 4840002

    Cuernavaca, 62250

  • Investigational Site Number 4840025

    Distrito Federal, 07760

  • Investigational Site Number 4840007

    Durango, 34000

  • Investigational Site Number 4840023

    Durango, 34080

  • Investigational Site Number 4840033

    Guadalajara, 44150

  • Investigational Site Number 4840024

    Guadalajara, 44160

  • Investigational Site Number 4840003

    Guadalajara, 44210

  • Investigational Site Number 4840011

    Guadalajara, 44210

  • Investigational Site Number 4840027

    Guadalajara, 44280

  • Investigational Site Number 4840004

    Guadalajara, 44600

  • Investigational Site Number 4840010

    Guadalajara, 44650

  • Investigational Site Number 4840030

    Guadalajara

  • Investigational Site Number 4840028

    Mérida, 72129

  • Investigational Site Number 4840034

    Mérida, 97070

  • Investigational Site Number 4840018

    Mexico City, 06760

  • Investigational Site Number 4840021

    Monterrey, 64020

  • Investigational Site Number 4840020

    Monterrey, 64060

  • Investigational Site Number 4840001

    Monterrey, 64460

  • Investigational Site Number 4840014

    Querétaro, 76000

  • Investigational Site Number 4840015

    Toluca, 50130

  • Investigational Site Number 4840008

    Veracruz, 91910

  • Investigational Site Number 4840016

    Xalapa, 91193

  • Investigational Site Number 4840026

    Zapopan, 45116

Other trials in Mexico

Brazil26 sites

  • Investigational Site Number 0760017

    Blumenau, 89020-430

  • Investigational Site Number 0760015

    Brasília, 70200-730

  • Investigational Site Number 0760026

    Brasília, 70390-903

  • Investigational Site Number 0760008

    Campinas, 13015-001

  • Investigational Site Number 0760005

    Campinas, 13060-080

  • Investigational Site Number 0760018

    Canoas, 92425-900

  • Investigational Site Number 0760019

    Curitiba, 80030-110

  • Investigational Site Number 0760011

    Curitiba, 80230-130

  • Investigational Site Number 0760007

    Curitiba, 80730-150

  • Investigational Site Number 0760010

    Fortaleza, 60115-282

  • Investigational Site Number 0760002

    Fortaleza, 60170-320

  • Investigational Site Number 0760004

    Fortaleza, 60430-350

  • Investigational Site Number 0760014

    Passo Fundo, 99010-180

  • Investigational Site Number 0760025

    Porto Alegre, 90020-090

  • Investigational Site Number 0760016

    Porto Alegre, 90430-001

  • Investigational Site Number 0760024

    Recife, 52051-380

  • Investigational Site Number 0760023

    Rio de Janeiro, 22271-100

  • Investigational Site Number 0760001

    São José do Rio Preto, 15090-000

  • Investigational Site Number 0760012

    São José dos Campos, 12243-280

  • Investigational Site Number 0760003

    São Paulo, 01.228-000

  • Investigational Site Number 0760020

    São Paulo, 01228-200

  • Investigational Site Number 0760013

    São Paulo, 04038-002

  • Investigational Site Number 0760022

    São Paulo, 04266-010

  • Investigational Site Number 0760006

    São Paulo, 05403-000

  • Investigational Site Number 0760009

    São Paulo, 05403-000

  • Investigational Site Number 0760021

    Vitória, 29055 450

Other trials in Brazil

Chile25 sites

  • Investigational Site Number 1520015

    Concepción, 4070566

  • Investigational Site Number 1520003

    Osorno, 5311092

  • Investigational Site Number 1520012

    Punta Arenas, 6210490

  • Investigational Site Number 1520013

    Santiago, 7500571

  • Investigational Site Number 1520018

    Santiago, 7500588

  • Investigational Site Number 1520001

    Santiago, 7500710

  • Investigational Site Number 1520004

    Santiago, 7500710

  • Investigational Site Number 1520006

    Santiago, 7500739

  • Investigational Site Number 1520014

    Santiago, 7591047

  • Investigational Site Number 1520016

    Santiago, 7650568

  • Investigational Site Number 1520017

    Santiago, 7770086

  • Investigational Site Number 1520020

    Santiago, 7770086

  • Investigational Site Number 1520009

    Santiago, 8053095

  • Investigational Site Number 1520011

    Santiago, 8207257

  • Investigational Site Number 1520026

    Santiago, 833-0024

  • Investigational Site Number 1520010

    Santiago, 8330336

  • Investigational Site Number 1520007

    Santiago, 8380456

  • Investigational Site Number 1520021

    Santiago, 8900132

  • Investigational Site Number 1520022

    Santiago, 8910131

  • Investigational Site Number 1520002

    Santiago

  • Investigational Site Number 1520024

    Talca

  • Investigational Site Number 1520019

    Temuco, 4781156

  • Investigational Site Number 1520025

    Temuco, 4781173

  • Investigational Site Number 1520005

    Temuco, 4813299

  • Investigational Site Number 1520008

    Viña del Mar

Other trials in Chile

Spain22 sites

  • Investigational Site Number 7240015

    A Coruña, 15006

  • Investigational Site Number 7240003

    Almería, 04120

  • Investigational Site Number 7240014

    Barcelona, 08035

  • Investigational Site Number 7240011

    Barcelona, 08041

  • Investigational Site Number 7240009

    Córdoba, 14004

  • Investigational Site Number 7240024

    El Puerto de Santa María, 11500

  • Investigational Site Number 7240016

    Granada, 18016

  • Investigational Site Number 7240001

    Madrid, 28023

  • Investigational Site Number 7240019

    Madrid, 28034

  • Investigational Site Number 7240006

    Madrid, 28040

  • Investigational Site Number 7240010

    Madrid, 28046

  • Investigational Site Number 7240020

    Madrid, 28046

  • Investigational Site Number 7240025

    Sabadell, 08208

  • Investigational Site Number 7240023

    Sanlúcar de Barrameda, 11540

  • Investigational Site Number 7240013

    Santa Cruz de Tenerife, 38320

  • Investigational Site Number 7240007

    Santiago de Compostela, 15706

  • Investigational Site Number 7240026

    Seville, 41014

  • Investigational Site Number 7240012

    Seville, 41071

  • Investigational Site Number 7240004

    Valencia, 46010

  • Investigational Site Number 7240002

    Vigo, 36312

  • Investigational Site Number 7240022

    Villamartín, 11650

  • Investigational Site Number 7240008

    Zaragoza, 50009

Other trials in Spain

Ukraine22 sites

  • Investigational Site Number 8040020

    Dnipro, 49005

  • Investigational Site Number 8040006

    Dnipro, 49600

  • Investigational Site Number 8040009

    Ivano-Frankivsk, 76000

  • Investigational Site Number 8040012

    Ivano-Frankivsk, 76018

  • Investigational Site Number 8040021

    Kharkiv, 61039

  • Investigational Site Number 8040011

    Kharkiv, 61058

  • Investigational Site Number 8040008

    Kharkiv, 61166

  • Investigational Site Number 8040002

    Kiev, 02091

  • Investigational Site Number 8040024

    Kiev, 02660

  • Investigational Site Number 8040003

    Kyiv, 03049

  • Investigational Site Number 8040015

    Kyiv, 03115

  • Investigational Site Number 8040019

    Kyiv, 04050

  • Investigational Site Number 8040010

    Kyiv, 04114

  • Investigational Site Number 8040026

    Kyiv

  • Investigational Site Number 8040023

    Lutsk, 43005

  • Investigational Site Number 8040025

    Lutsk, 43024

  • Investigational Site Number 8040022

    Lviv, 79011

  • Investigational Site Number 8040001

    Ternopil, 46000

  • Investigational Site Number 8040016

    Vinnitsya, 21018

  • Investigational Site Number 8040007

    Vinnitsya, 21100

  • Investigational Site Number 8040004

    Vinnytsia, 21001

  • Investigational Site Number 8040018

    Zhytomyr

Other trials in Ukraine

Peru20 sites

  • Investigational Site Number 6040004

    Arequipa

  • Investigational Site Number 6040006

    Callao, CALLAO 02

  • Investigational Site Number 6040009

    Callao

  • Investigational Site Number 6040024

    Chancay

  • Investigational Site Number 6040005

    Chiclayo

  • Investigational Site Number 6040010

    Cuzco

  • Investigational Site Number 6040001

    Lima, 09

  • Investigational Site Number 6040025

    Lima, 15135

  • Investigational Site Number 6040016

    Lima, LIMA 01

  • Investigational Site Number 6040020

    Lima, LIMA 14

  • Investigational Site Number 6040013

    Lima, Lima 17

  • Investigational Site Number 6040023

    Lima, LIMA 27

  • Investigational Site Number 6040007

    Lima, Lima 29

  • Investigational Site Number 6040019

    Lima, LIMA 31

  • Investigational Site Number 6040022

    Lima, LIMA 32

  • Investigational Site Number 6040012

    Lima, Lima 41

  • Investigational Site Number 6040017

    Lima

  • Investigational Site Number 6040014

    Lima Lima, Lima 01

  • Investigational Site Number 6040011

    Piura, 20000

  • Investigational Site Number 6040002

    Trujillo

Other trials in Peru

Australia18 sites

  • Investigational Site Number 0360014

    Adelaide, 5000

  • Investigational Site Number 0360004

    Box Hill, 3128

  • Investigational Site Number 0360015

    Elizabeth Vale, 5112

  • Investigational Site Number 0360005

    Fitzroy, 3065

  • Investigational Site Number 0360018

    Fremantle, 6160

  • Investigational Site Number 0360007

    Fullarton, 5063

  • Investigational Site Number 0360002

    Gosford, 2250

  • Investigational Site Number 0360016

    Heidelberg, 3081

  • Investigational Site Number 0360010

    Herston, 4029

  • Investigational Site Number 0360009

    Liverpool, 2170

  • Investigational Site Number 0360017

    Melbourne, 3004

  • Investigational Site Number 0360001

    Merewether, 2291

  • Investigational Site Number 0360012

    Oaklands Park, 5046

  • Investigational Site Number 0360011

    Parkville, 3050

  • Investigational Site Number 0360008

    Redcliffe, 4020

  • Investigational Site Number 0360013

    Sherwood, 4075

  • Investigational Site Number 0360019

    St Leonards, 2065

  • Investigational Site Number 0360006

    Wollongong, 2500

Other trials in Australia

Czechia18 sites

  • Investigational Site Number 2030012

    Brno, 62500

  • Investigational Site Number 2030002

    Brno, 63900

  • Investigational Site Number 2030021

    Broumov, 550 01

  • Investigational Site Number 2030017

    Humpolec, 396 01

  • Investigational Site Number 2030014

    Liberec, 46063

  • Investigational Site Number 2030007

    Mariánské Lázně, 353 01

  • Investigational Site Number 2030015

    Městec Králové, 28903

  • Investigational Site Number 2030009

    Pilsen, 301 00

  • Investigational Site Number 2030016

    Prague, 10800

  • Investigational Site Number 2030019

    Prague, 11694

  • Investigational Site Number 2030006

    Prague, 12808

  • Investigational Site Number 2030005

    Prague, 14021

  • Investigational Site Number 2030011

    Prague, 16900

  • Investigational Site Number 2030018

    Prague, 18100

  • Investigational Site Number 2030010

    Řevnice, 25230

  • Investigational Site Number 2030020

    Slaný, 27401

  • Investigational Site Number 2030001

    Trutnov, 54101

  • Investigational Site Number 2030008

    Vsetín, 75501

Other trials in Czechia

Hungary16 sites

  • Investigational Site Number 3480006

    Békéscsaba, 5600

  • Investigational Site Number 3480017

    Budapest, 1027

  • Investigational Site Number 3480004

    Budapest, 1042

  • Investigational Site Number 3480011

    Budapest, 1096

  • Investigational Site Number 3480001

    Budapest, 1122

  • Investigational Site Number 3480010

    Budapest, 1125

  • Investigational Site Number 3480012

    Budapest, 1134

  • Investigational Site Number 3480016

    Budapest, 1145

  • Investigational Site Number 3480018

    Budapest, 1204

  • Investigational Site Number 3480002

    Debrecen, 4032

  • Investigational Site Number 3480008

    Debrecen, 4032

  • Investigational Site Number 3480013

    Kaposvár, 7400

  • Investigational Site Number 3480014

    Nyíregyháza, 4400

  • Investigational Site Number 3480015

    Nyíregyháza, 4400

  • Investigational Site Number 3480003

    Székesfehérvár, 8000

  • Investigational Site Number 3480007

    Zalaegerszeg, 8900

Other trials in Hungary

Turkey (Türkiye)16 sites

  • Investigational Site Number 7920018

    Antalya, 07070

  • Investigational Site Number 7920010

    Aydin, 09100

  • Investigational Site Number 7920004

    Çorum, 19200

  • Investigational Site Number 7920016

    Gaziantep, 27310

  • Investigational Site Number 7920011

    Istanbul, 34034

  • Investigational Site Number 7920009

    Istanbul, 34390

  • Investigational Site Number 7920001

    Istanbul

  • Investigational Site Number 7920007

    Istanbul

  • Investigational Site Number 7920017

    Istanbul

  • Investigational Site Number 7920003

    Izmir, 35340

  • Investigational Site Number 7920013

    Kayseri, 38039

  • Investigational Site Number 7920014

    Kocaeli, 41380

  • Investigational Site Number 7920005

    Kütahya

  • Investigational Site Number 7920015

    Malatya

  • Investigational Site Number 7920008

    Mersin, 33169

  • Investigational Site Number 7920002

    Sivas, 58140

Other trials in Turkey (Türkiye)

Bulgaria15 sites

  • Investigational Site Number 1000015

    Blagoevgrad, 2700

  • Investigational Site Number 1000008

    Dobrich, MULTIPROFILE HOSPITA

  • Investigational Site Number 1000013

    Gabrovo, 5300

  • Investigational Site Number 1000003

    Plovdiv, 4002

  • Investigational Site Number 1000016

    Rousse, 7002

  • Investigational Site Number 1000014

    Silistra, 7500

  • Investigational Site Number 1000007

    Smolyan, 4700

  • Investigational Site Number 1000011

    Sofia, 1233

  • Investigational Site Number 1000004

    Sofia, 1431

  • Investigational Site Number 1000006

    Sofia, 1431

  • Investigational Site Number 1000012

    Sofia, 1632

  • Investigational Site Number 1000005

    Sofia, 1750

  • Investigational Site Number 1000017

    Sofia, 1784

  • Investigational Site Number 1000001

    Stara Zagora, 6000

  • Investigational Site Number 1000018

    Stara Zagora, 6000

Other trials in Bulgaria

New Zealand15 sites

  • Investigational Site Number 5540014

    Auckland, 1023

  • Investigational Site Number 5540006

    Birkenhead, 0626

  • Investigational Site Number 5540009

    Birkenhead, 0626

  • Investigational Site Number 5540002

    Christchurch, 8011

  • Investigational Site Number 5540003

    Christchurch

  • Investigational Site Number 5540012

    Christchurch

  • Investigational Site Number 5540007

    Dunedin, 9016

  • Investigational Site Number 5540016

    Hamilton, 3240

  • Investigational Site Number 5540013

    New Plymouth

  • Investigational Site Number 5540015

    Palmerston North, 4414

  • Investigational Site Number 5540005

    Rotorua, 3010

  • Investigational Site Number 5540010

    Takapuna, 1309

  • Investigational Site Number 5540008

    Tauranga, 3001

  • Investigational Site Number 5540011

    Tauranga, 3001

  • Investigational Site Number 5540004

    Wellington, 6021

Other trials in New Zealand

Romania14 sites

  • Investigational Site Number 6420008

    Bacau, 600154

  • Investigational Site Number 6420005

    Baia Mare, Maramures, 430222

  • Investigational Site Number 6420009

    Brasov, 500097

  • Investigational Site Number 6420013

    Bucharest, 010507

  • Investigational Site Number 6420014

    Bucharest, 010627

  • Investigational Site Number 6420012

    Bucharest, 020475

  • Investigational Site Number 6420011

    Bucharest, 022441

  • Investigational Site Number 6420002

    Craiova, 200349

  • Investigational Site Number 6420003

    Oradea, 410159

  • Investigational Site Number 6420004

    Oradea, 410469

  • Investigational Site Number 6420010

    Ploieşti, 100561

  • Investigational Site Number 6420001

    Targoviste, Dambovita, 130095

  • Investigational Site Number 6420006

    Targu Mures, Mures, 540142

  • Investigational Site Number 6420007

    Targu Mures, Mures, 540142

Other trials in Romania

South Africa13 sites

  • Investigational Site Number 7100005

    Brits, 0250

  • Investigational Site Number 7100009

    Cape Town, 7530

  • Investigational Site Number 7100006

    Cape Town, 7570

  • Investigational Site Number 7100002

    eMkhomazi, 4170

  • Investigational Site Number 7100001

    Parow, 7500

  • Investigational Site Number 7100012

    Pinelands, 7405

  • Investigational Site Number 7100011

    Pretoria, 0002

  • Investigational Site Number 7100014

    Pretoria, 0083

  • Investigational Site Number 7100008

    Pretoria, 0157

  • Investigational Site Number 7100010

    Rivonia, 2128

  • Investigational Site Number 7100007

    Soweto, 1818

  • Investigational Site Number 7100013

    Vosloorus, 1475

  • Investigational Site Number 7100003

    Western Cape, 7130

Other trials in South Africa

Slovakia12 sites

  • Investigational Site Number 7030006

    Bardejov, 085 01

  • Investigational Site Number 7030012

    Bratislava, 813 69

  • Investigational Site Number 7030011

    Košice, 040 01

  • Investigational Site Number 7030001

    Ľubochňa, 034 91

  • Investigational Site Number 7030008

    Lučenec, 984 39

  • Investigational Site Number 7030009

    Lučenec, 98401

  • Investigational Site Number 7030010

    Lučenec, 98401

  • Investigational Site Number 7030004

    Moldava nad Bodvou, 04525

  • Investigational Site Number 7030013

    Prešov, 080 01

  • Investigational Site Number 7030003

    Rožňava, 04801

  • Investigational Site Number 7030002

    Sabinov, 083 01

  • Investigational Site Number 7030007

    Svidník, 089 01

Other trials in Slovakia

Italy10 sites

  • Investigational Site Number 3800006

    Catanzaro, 88100

  • Investigational Site Number 3800010

    Catanzaro, 88100

  • Investigational Site Number 3800009

    Chieri, 10023

  • Investigational Site Number 3800007

    Livorno, 57123

  • Investigational Site Number 3800002

    Milan, 20132

  • Investigational Site Number 3800008

    Milan, 20145

  • Investigational Site Number 3800005

    Orbassano, 10043

  • Investigational Site Number 3800011

    Ravenna, 48100

  • Investigational Site Number 3800004

    Roma, 00133

  • Investigational Site Number 3800001

    Verona, 37126

Other trials in Italy

South Korea10 sites

  • Investigational Site Number 4100011

    Bucheon-si, 14647

  • Investigational Site Number 4100005

    Busan, 49201

  • Investigational Site Number 4100007

    Gwangju, 61469

  • Investigational Site Number 4100001

    Incheon, 22332

  • Investigational Site Number 4100002

    Seongnam-si, 13620

  • Investigational Site Number 4100003

    Seoul, 03080

  • Investigational Site Number 4100006

    Seoul, 03722

  • Investigational Site Number 4100008

    Seoul, 05505

  • Investigational Site Number 4100004

    Seoul, 06351

  • Investigational Site Number 4100010

    Uijeongbu-si, 11765

Other trials in South Korea

Guatemala9 sites

  • Investigational Site Number 3200007

    Guatemala City, 01001

  • Investigational Site Number 3200013

    Guatemala City, 01010

  • Investigational Site Number 3200001

    Guatemala City, 01014

  • Investigational Site Number 3200002

    Guatemala City, 1010

  • Investigational Site Number 3200009

    Guatemala City, 1010

  • Investigational Site Number 3200010

    Guatemala City

  • Investigational Site Number 3200006

    Quetzaltenango, 09001

  • Investigational Site Number 3200014

    Quetzaltenango, 09001

  • Investigational Site Number 3200004

    Quetzaltenango, 9011

Other trials in Guatemala

Lithuania9 sites

  • Investigational Site Number 4400006

    Kaunas, 49449

  • Investigational Site Number 4400003

    Kaunas, 51270

  • Investigational Site Number 4400009

    Kaunas, LT-50161

  • Investigational Site Number 4400008

    Kėdainiai, LT-57164

  • Investigational Site Number 4400004

    Klaipėda, 92111

  • Investigational Site Number 4400002

    Klaipėda, LT-92304

  • Investigational Site Number 4400007

    Ukmerge, 20184

  • Investigational Site Number 4400005

    Utena, LT-28151

  • Investigational Site Number 4400001

    Vilnius, 08661

Other trials in Lithuania

United Kingdom9 sites

  • Investigational Site Number 8260003

    Belfast, BT12 6BA

  • Investigational Site Number 8260007

    Chippenham, SN14 6GT

  • Investigational Site Number 8260009

    Davyhulme, Manchester, M41 5SL

  • Investigational Site Number 8260010

    Glasgow, G21 3UW

  • Investigational Site Number 8260004

    Hayle, TR27 5DT

  • Investigational Site Number 8260011

    Inverness, IV2 3UJ

  • Investigational Site Number 8260002

    Ipswich, IP4 5PD

  • Investigational Site Number 8260006

    Maidstone, ME16 9QQ

  • Investigational Site Number 8260001

    Swansea, SA2 8PP

Other trials in United Kingdom

Denmark8 sites

  • Investigational Site Number 2080003

    Aarhus N, 8200

  • Investigational Site Number 2080005

    Aarhus N, 8200

  • Investigational Site Number 2080009

    Gentofte Municipality, 2900

  • Investigational Site Number 2080004

    Herlev, 2730

  • Investigational Site Number 2080008

    Hvidovre, 2650

  • Investigational Site Number 2080002

    København NV, 2400

  • Investigational Site Number 2080007

    Slagelse, 4200

  • Investigational Site Number 2080006

    Svendborg, 5700

Other trials in Denmark

Germany8 sites

  • Investigational Site Number 2760008

    Berlin, 12351

  • Investigational Site Number 2760005

    Essen, 45136

  • Investigational Site Number 2760001

    Freiburg im Breisgau, 79106

  • Investigational Site Number 2760007

    Hamburg, 22041

  • Investigational Site Number 2760002

    Kassel, 34121

  • Investigational Site Number 2760006

    Leipzig, 04103

  • Investigational Site Number 2760003

    Münster, 48149

  • Investigational Site Number 2760009

    Oldenburg in Holstein, 23758

Other trials in Germany

Israel8 sites

  • Investigational Site Number 3760008

    Beersheba, 84101

  • Investigational Site Number 3760005

    Haifa, 31048

  • Investigational Site Number 3760007

    Haifa, 31096

  • Investigational Site Number 3760001

    Jerusalem, 91031

  • Investigational Site Number 3760002

    Jerusalem, 91120

  • Investigational Site Number 3760004

    Nahariya, 22100

  • Investigational Site Number 3760003

    Tel Aviv, 64239

  • Investigational Site Number 3760006

    Tel HaShomer, 52621

Other trials in Israel

Portugal8 sites

  • Investigational Site Number 6200004

    Almada, 2801-951

  • Investigational Site Number 6200005

    Caldas da Rainha, 2500-176

  • Investigational Site Number 6200009

    Carnaxide, 2790-134

  • Investigational Site Number 6200002

    Coimbra, 3000-075

  • Investigational Site Number 6200008

    Leiria, 2410-197

  • Investigational Site Number 6200001

    Lisbon, 1250

  • Investigational Site Number 6200007

    Loures, 2674-514

  • Investigational Site Number 6200003

    Porto, 4099-001

Other trials in Portugal

Sweden8 sites

  • Investigational Site Number 7520007

    Falun, 791 82

  • Investigational Site Number 7520005

    Lund, 221 85

  • Investigational Site Number 7520004

    Mölndal, 43180

  • Investigational Site Number 7520003

    Rättvik, 79530

  • Investigational Site Number 7520008

    Stockholm, 112 21

  • Investigational Site Number 7520002

    Stockholm, 118 83

  • Investigational Site Number 7520006

    Stockholm, 14186

  • Investigational Site Number 7520001

    Uppsala, 751 85

Other trials in Sweden

Taiwan8 sites

  • Investigational Site Number 1580005

    Hsinchu, 30071

  • Investigational Site Number 1580008

    Kaohsiung City, 807

  • Investigational Site Number 1580004

    Linkou District

  • Investigational Site Number 1580006

    Taichung, 40447

  • Investigational Site Number 1580002

    Tainan, 704

  • Investigational Site Number 1580007

    Tainan, 710

  • Investigational Site Number 1580003

    Taipei, 100

  • Investigational Site Number 1580001

    Taipei, 112

Other trials in Taiwan

France7 sites

  • Investigational Site Number 2500003

    Corbeil-Essonnes, 91106

  • Investigational Site Number 2500002

    La Rochelle, 17019

  • Investigational Site Number 2500005

    Paris, 75010

  • Investigational Site Number 2500006

    Paris, 75018

  • Investigational Site Number 2500001

    Paris, 75877

  • Investigational Site Number 2500004

    Toulouse, 31059

  • Investigational Site Number 2500007

    Vénissieux, 69200

Other trials in France

Georgia7 sites

  • Investigational Site Number 2680004

    Batumi, 6010

  • Investigational Site Number 2680001

    Kutaisi

  • Investigational Site Number 2680007

    Tbilisi, 0159

  • Investigational Site Number 2680005

    Tbilisi, 102

  • Investigational Site Number 2680003

    Tbilisi, 159

  • Investigational Site Number 2680006

    Tbilisi, 159

  • Investigational Site Number 2680002

    Tbilisi

Other trials in Georgia

Latvia7 sites

  • Investigational Site Number 4280004

    Daugavpils, LV-5417

  • Investigational Site Number 4280002

    Liepāja, LV3414

  • Investigational Site Number 4280007

    Ogre, LV-5001

  • Investigational Site Number 4280006

    Riga, LV-1002

  • Investigational Site Number 4280001

    Riga, LV-1011

  • Investigational Site Number 4280005

    Riga, LV-1038

  • Investigational Site Number 4280003

    Sigulda, LV-2150

Other trials in Latvia

Serbia7 sites

  • Investigational Site Number 6880002

    Belgrade, 11000

  • Investigational Site Number 6880003

    Belgrade, 11000

  • Investigational Site Number 6880004

    Belgrade, 11000

  • Investigational Site Number 6880005

    Kragujevac, 34000

  • Investigational Site Number 6880001

    Niš, 18000

  • Investigational Site Number 6880006

    Niš, 18000

  • Investigational Site Number 6880007

    Niš, 18000

Other trials in Serbia

Belgium5 sites

  • Investigational Site Number 0560004

    Bonheiden, 2820

  • Investigational Site Number 0560005

    Ghent, 9000

  • Investigational Site Number 0560003

    Kortrijk, 8500

  • Investigational Site Number 0560002

    La Louvière, 7100

  • Investigational Site Number 0560001

    Leuven, 3000

Other trials in Belgium

Greece5 sites

  • Investigational Site Number 3000001

    Athens, 11527

  • Investigational Site Number 3000002

    Ioannina, 45500

  • Investigational Site Number 3000004

    Larissa, 41110

  • Investigational Site Number 3000003

    Piraeus, 18454

  • Investigational Site Number 3000005

    Thessaloniki, 54629

Other trials in Greece

Netherlands5 sites

  • Investigational Site Number 5280004

    Almelo, 7609 PP

  • Investigational Site Number 5280001

    Groningen, 9728 NT

  • Investigational Site Number 5280003

    Hoogeveen, 7909 AA

  • Investigational Site Number 5280005

    Meppel, 7943 KA

  • Investigational Site Number 5280002

    Rotterdam, 3045 PM

Other trials in Netherlands

Norway5 sites

  • Investigational Site Number 5780005

    Hamar, 2317

  • Investigational Site Number 5780001

    Hønefoss, 3515

  • Investigational Site Number 5780003

    Oslo, 0514

  • Investigational Site Number 5780002

    Oslo, 373

  • Investigational Site Number 5780004

    Skedsmokorset, 2020

Other trials in Norway

North Macedonia4 sites

  • Investigational Site Number 8070003

    Skopje, 1000

  • Investigational Site Number 8070005

    Struga, 6330

  • Investigational Site Number 8070001

    Tetovo, 1200

  • Investigational Site Number 8070004

    Tetovo, 1200

Other trials in North Macedonia

Estonia3 sites

  • Investigational Site Number 2330003

    Tallinn, 10138

  • Investigational Site Number 2330001

    Tallinn, 13419

  • Investigational Site Number 2330002

    Tartu, 51014

Other trials in Estonia

Switzerland2 sites

  • Investigational Site Number 7560001

    Olten, 4600

  • Investigational Site Number 7560002

    Zollikerberg, 8125

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Puerto Rico1 site

  • Investigational Site Number 8400122

    San Juan, 00917

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About this study

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

The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.

Being tested
Sotagliflozin, Placebo
Medical subject headings
Heart Failure, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotagliflozinDrug

    Also called SAR439954

    Sotagliflozin was administered as a tablet(s), orally once daily.

  • PlaceboDrug

    Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.

Study groups in NCT03315143
Study groupRoleWhat they receive
SotagliflozinExperimentalSotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
Receives: Drug: Sotagliflozin
PlaceboPlacebo comparatorMatching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 30 months

Secondary outcomes (7)

  1. 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.

    Measured: Up to 30 months

  2. 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.

    Measured: Up to 30 months

  3. 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 randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.

    Measured: Up to 30 months

  4. 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 randomization of HHF, urgent HF visits, CV Death, and HF while hospitalized. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.

    Measured: Up to 30 months

  5. Number of Occurrences After Randomization of the Composite of Sustained ≥50% Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline (for ≥30 Days), Chronic Dialysis, Renal Transplant, or Sustained eGFR <15 mL/Min/1.73 m^2 (for ≥30 Days)

    Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.

    Measured: Up to 30 months

  6. 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.

    Measured: Up to 30 months

  7. Total Number of Occurrences of CV Death, Non-fatal Myocardial Infarction and Non-fatal Stroke

    Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death 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.

    Measured: Up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2017
  2. Study start19 Dec 2017
  3. Primary completion8 Jul 2020
  4. Study completion8 Jul 2020

Why it stopped: study terminated due to business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10,584 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03315143
Sponsor's protocol ID
EFC14875
Other IDs
2017-002644-32, U1111-1187-8703, 2017
Acronym
SCORED
Status last verified
Sep 2022
First submitted
16 Oct 2017
Last updated
28 Oct 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Aggarwal R, Bhatt DL, Szarek M, Cannon CP, Leiter LA, Inzucchi SE, Lopes RD, McGuire DK, Lewis JB, Riddle MC, Davies MJ, Banks P, Carroll AK, Scirica BM, Ray KK, Kosiborod MN, Cherney DZI, Udell JA, Verma S, Mason RP, Pitt B, Steg PG. Effect of sotagliflozin on major adverse cardiovascular events: a prespecified secondary analysis of the SCORED randomised trial. Lancet Diabetes Endocrinol. 2025 Apr;13(4):321-332. doi: 10.1016/S2213-8587(24)00362-0. Epub 2025 Feb 14.

    PubMed 39961315

  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

    PubMed 38770818

  • Sridhar VS, Bhatt DL, Odutayo A, Szarek M, Davies MJ, Banks P, Pitt B, Steg PG, Cherney DZI. Sotagliflozin and Kidney Outcomes, Kidney Function, and Albuminuria in Type 2 Diabetes and CKD: A Secondary Analysis of the SCORED Trial. Clin J Am Soc Nephrol. 2024 May 1;19(5):557-564. doi: 10.2215/CJN.0000000000000414. Epub 2024 Jan 26.

    PubMed 38277468

  • Bhatt DL, Szarek M, Pitt B, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Inzucchi SE, Kosiborod MN, Cherney DZI, Dwyer JP, Scirica BM, Bailey CJ, Diaz R, Ray KK, Udell JA, Lopes RD, Lapuerta P, Steg PG; SCORED Investigators. Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease. N Engl J Med. 2021 Jan 14;384(2):129-139. doi: 10.1056/NEJMoa2030186. Epub 2020 Nov 16.

    PubMed 33200891

  • Cefalo CMA, Cinti F, Moffa S, Impronta F, Sorice GP, Mezza T, Pontecorvi A, Giaccari A. Sotagliflozin, the first dual SGLT inhibitor: current outlook and perspectives. Cardiovasc Diabetol. 2019 Feb 28;18(1):20. doi: 10.1186/s12933-019-0828-y.

    PubMed 30819210

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotagliflozin in people with Heart Failure and Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 754 sites in 45 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 754 sites in United States, Russia, India, China, Poland and 40 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF) (time frame: Up to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03315143, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.

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