AzTrials
AzTrials

Acute Coronary SyndromePhase 3ELIXANCT01147250

Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

A Phase 3 study testing Lixisenatide (AVE0010) in people with Acute Coronary Syndrome, run by Sanofi at 829 sites in 49 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who recently experienced an acute… Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Lixisenatide (AVE0010)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,068 participants
Where
829 sitesin 49 countries
Study dates
Jun 2010to Feb 2015
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 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women who experienced a spontaneous ACS event (i.e., ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation MI (NSTEMI) or unstable angina) with a documented elevation above the normal reference range of a cardiac biomarker (Troponin or Creatinine Kinase (CK)-MB) and the clinical presentation consistent with an ACS which lead to admission to an acute care facility, within 180 days following the ACS event and prior to screening.
  • Participants with a history of type 2 diabetes (for participants newly diagnosed, diagnosis was based on the World Health Organization (WHO) criteria: i.e., either a fasting venous plasma glucose concentration ≥ 7.0 mmol/L [126 mg/dL] or 2-hour post glucose load venous plasma glucose ≥ 11.1 mmol/L [200 mg/dL], confirmed on 2 occasions) prior to the screening visit.

Who cannot join

  • Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to screening.
  • Glycosylated hemoglobin (HbA1c) <5.5 % or >11% measured at screening visit.
  • Required to use incretin-based agents (e.g., Glucagon-like peptide -1 (GLP-1) agonists or Dipeptidyl Peptidase-4 (DPP-4) inhibitors) other than the study drug during the double-blind treatment period.
  • Participants who had undergone coronary artery bypass graft (CABG) surgery following the qualifying ACS event.
  • Participants who had undergone percutaneous coronary intervention (PCI) within 15 days prior to screening.
  • Participants with planned revascularization procedure (PCI or CABG) or coronary angiogram within 90 days after screening visit.
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  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC), or genetic conditions that predisposes to MTC (e.g., multiple endocrine neoplasia syndromes).
  • Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases.
  • 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

829 sites in 49 countries.

829 sites in 49 countries

United States200 sites

  • Investigational Site Number 840285

    Albany, New York, 12206

  • Investigational Site Number 840019

    Alpena, Michigan, 49707

  • Investigational Site Number 840232

    American Fork, Utah, 84003

  • Investigational Site Number 840706

    Anaheim, California, 92801

  • Investigational Site Number 840497

    Anaheim, California, 92804

  • Investigational Site Number 840223

    Anderson, South Carolina, 29621

  • Investigational Site Number 840043

    Annapolis, Maryland, 21401

  • Investigational Site Number 840519

    Arlington Heights, Illinois, 60005

  • Investigational Site Number 840310

    Asheville, North Carolina, 28805

  • Investigational Site Number 840066

    Atlanta, Georgia, 30322

  • Investigational Site Number 840446

    Atlanta, Georgia, 30322

  • Investigational Site Number 840487

    Atlanta, Georgia, 30322

  • Investigational Site Number 840524

    Bartlett, Tennessee, 38133

  • Investigational Site Number 840299

    Baton Rouge, Louisiana, 70808

  • Investigational Site Number 840589

    Belleville, Illinois, 62220

  • Investigational Site Number 840427

    Bend, Oregon, 97701

  • Investigational Site Number 840196

    Biloxi, Mississippi, 39531

  • Investigational Site Number 840415

    Birmingham, Alabama, 35203

  • Investigational Site Number 840578

    Blue Ridge, Georgia, 30513

  • Investigational Site Number 840352

    Buckley, Michigan, 49620

  • Investigational Site Number 840560

    Butler, Pennsylvania, 16001

  • Investigational Site Number 840454

    Calabash, North Carolina, 28467

  • Investigational Site Number 840639

    Catonsville, Maryland, 21228

  • Investigational Site Number 840672

    Charlotte, North Carolina, 28203

  • Investigational Site Number 840152

    Charlotte, North Carolina, 28205

  • Investigational Site Number 840503

    Charlottesville, Virginia, 22908-0679

  • Investigational Site Number 840308

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840180

    Chesapeake, Virginia, 23320

  • Investigational Site Number 840465

    Chesapeake, Virginia, 23321

  • Investigational Site Number 840128

    Chesapeake, Virginia, 23323

  • Investigational Site Number 840555

    Chesterfield, Michigan, 48047

  • Investigational Site Number 840107

    Chicago, Illinois, 60415

  • Investigational Site Number 840633

    Chicago, Illinois, 60611

  • Investigational Site Number 840663

    Chicago, Illinois, 60612

  • Investigational Site Number 840028

    Cincinnati, Ohio, 45219

  • Investigational Site Number 840198

    Cincinnati, Ohio, 45220

  • Investigational Site Number 840464

    Clark Summit, Pennsylvania, 18411

  • Investigational Site Number 840281

    Clearwater, Florida, 33755

  • Investigational Site Number 840093

    Colorado Springs, Colorado, 80910

  • Investigational Site Number 840353

    Columbia, South Carolina, 29201

  • Investigational Site Number 840534

    Columbus, Georgia, 31904-5245

  • Investigational Site Number 840543

    Columbus, Ohio, 43201

  • Investigational Site Number 840533

    Covington, Kentucky, 41011

  • Investigational Site Number 840473

    Dallas, Texas, 75246

  • Investigational Site Number 840456

    Dayton, Ohio, 45439

  • Investigational Site Number 840411

    Dearborn, Michigan, 48124

  • Investigational Site Number 840205

    Detroit, Michigan, 48235

  • Investigational Site Number 840667

    Downey, California, 90242

  • Investigational Site Number 840471

    Draper, Utah, 84020

  • Investigational Site Number 840447

    Duluth, Georgia, 30096

  • Investigational Site Number 840499

    Duluth, Georgia, 30096

  • Investigational Site Number 840219

    Duluth, Minnesota, 55805

  • Investigational Site Number 840199

    Eagan, Minnesota, 55122

  • Investigational Site Number 840677

    Edinburg, Texas, 78539

  • Investigational Site Number 840698

    El Paso, Texas, 79925

  • Investigational Site Number 840344

    Elizabeth City, North Carolina, 27909

  • Investigational Site Number 840360

    Elwood, Indiana, 46036

  • Investigational Site Number 840439

    Fair Oaks Ranch, Texas, 78015

  • Investigational Site Number 840613

    Fairmount, Wisconsin, 26554

  • Investigational Site Number 840581

    Flint, Michigan, 48503

  • Investigational Site Number 840307

    Foley, Alabama, 36535

  • Investigational Site Number 840150

    Fresno, California, 93722

  • Investigational Site Number 840676

    Gary, Indiana, 46409

  • Investigational Site Number 840047

    Germantown, Tennessee, 38138

  • Investigational Site Number 840328

    Greensboro, North Carolina, 27401

  • Investigational Site Number 840513

    Greensboro, North Carolina, 27405

  • Investigational Site Number 840504

    Greenville, North Carolina, 27858

  • Investigational Site Number 840529

    Greenville, South Carolina, 29605

  • Investigational Site Number 840550

    Greer, South Carolina, 29651

  • Investigational Site Number 840657

    Hammond, Indiana, 46320

  • Investigational Site Number 840671

    Hammond, Louisiana, 70403

  • Investigational Site Number 840624

    Hawthorne, California, 90250

  • Investigational Site Number 840212

    Hines, Illinois, 60141

  • Investigational Site Number 840477

    Homosassa, Florida, 34448

  • Investigational Site Number 840303

    Hot Springs, Arkansas, 71913

  • Investigational Site Number 840164

    Houston, Texas, 77081

  • Investigational Site Number 840621

    Huntington, Indiana, 46750

  • Investigational Site Number 840536

    Idaho Falls, Idaho, 83404

  • Investigational Site Number 840702

    Indianapolis, Indiana, 46202

  • Investigational Site Number 840623

    Inglewood, California, 90301

  • Investigational Site Number 840636

    Inglewood, California, 90301

  • Investigational Site Number 840313

    Jackson, Tennessee, 38305

  • Investigational Site Number 840585

    Jamaica, New York, 11432

  • Investigational Site Number 840345

    Joliet, Illinois, 60435

  • Investigational Site Number 840184

    Jonesboro, Arkansas, 72401

  • Investigational Site Number 840404

    Kalamazoo, Michigan, 49048

  • Investigational Site Number 840337

    Kalispell, Montana, 59901

  • Investigational Site Number 840445

    Kansas City, Missouri, 64111

  • Investigational Site Number 840008

    Kansas City, Missouri, 64128

  • Investigational Site Number 840121

    La Crosse, Wisconsin, 54601

  • Investigational Site Number 840455

    La Mesa, California, 91942

  • Investigational Site Number 840382

    Las Vegas, Nevada, 89102

  • Investigational Site Number 840680

    Las Vegas, Nevada, 89102

  • Investigational Site Number 840217

    Las Vegas, Nevada, 89148

  • Investigational Site Number 840509

    Lincoln, Nebraska, 68521

  • Investigational Site Number 840072

    Linden, New Jersey

  • Investigational Site Number 840361

    Little Rock, Arkansas, 72204

  • Investigational Site Number 840023

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840240

    Loma Linda, California, 92354

  • Investigational Site Number 840262

    Long Beach, California, 90806

  • Investigational Site Number 840606

    Long Beach, California, 90813

  • Investigational Site Number 840545

    Longview, Texas, 75605

  • Investigational Site Number 840694

    Los Angeles, California, 90024

  • Investigational Site Number 840431

    Los Angeles, California, 90033

  • Investigational Site Number 840135

    Los Angeles, California, 90073

  • Investigational Site Number 840385

    Lubbock, Texas, 79409

  • Investigational Site Number 840530

    Lubbock, Texas, 79409

  • Investigational Site Number 840251

    Madisonville, Kentucky, 42431

  • Investigational Site Number 840368

    Marion, Ohio, 43302

  • Investigational Site Number 840174

    Marshall, Texas, 75670

  • Investigational Site Number 840625

    Memphis, Tennessee, 38114

  • Investigational Site Number 840637

    Memphis, Tennessee, 38163

  • Investigational Site Number 840314

    Merced, California, 95348

  • Investigational Site Number 840656

    Mesa, Arizona, 85206

  • Investigational Site Number 840470

    Metairie, Louisiana, 70006

  • Investigational Site Number 840261

    Miami, Florida, 33135

  • Investigational Site Number 840459

    Miami, Florida, 33155

  • Investigational Site Number 840493

    Milwaukee, Wisconsin, 53211

  • Investigational Site Number 840348

    Mineola, New York, 11501

  • Investigational Site Number 840290

    Mission Viejo, California, 92691

  • Investigational Site Number 840692

    Mobile, Alabama, 36604

  • Investigational Site Number 840037

    Mobile, Alabama, 36608

  • Investigational Site Number 840210

    Mobile, Alabama, 36609

  • Investigational Site Number 840642

    Monroe, North Carolina, 28110

  • Investigational Site Number 840326

    Muscle Shoals, Alabama, 35661

  • Investigational Site Number 840258

    Myrtle Beach, South Carolina, 29572

  • Investigational Site Number 840096

    Nashville, Tennessee, 37208

  • Investigational Site Number 840388

    Nashville, Tennessee, 37232

  • Investigational Site Number 840592

    National City, California, 91950

  • Investigational Site Number 840045

    Norfolk, Virginia, 23502

  • Investigational Site Number 840213

    Norfolk, Virginia, 23510

  • Investigational Site Number 840119

    Northport, New York, 11768

  • Investigational Site Number 840275

    Northridge, California, 91328

  • Investigational Site Number 840654

    Oakland, California, 94609

  • Investigational Site Number 840170

    Olympia, Washington, 98506

  • Investigational Site Number 840007

    Omaha, Nebraska, 68131

  • Investigational Site Number 840351

    Orange, California, 92868

  • Investigational Site Number 840689

    Orange, California, 92868

  • Investigational Site Number 840432

    Oviedo, Florida, 32765

  • Investigational Site Number 840168

    Owensboro, Kentucky, 42303

  • Investigational Site Number 840318

    Panama City, Florida, 32401

  • Investigational Site Number 840681

    Peoria, Illinois, 61602

  • Investigational Site Number 840506

    Phoenix, Arizona, 85012

  • Investigational Site Number 840520

    Phoenix, Arizona, 85020

  • Investigational Site Number 840322

    Phoenix, Arizona, 85032

  • Investigational Site Number 840449

    Pikeville, Kentucky, 41501

  • Investigational Site Number 840401

    Pittsburgh, Pennsylvania, 15220

  • Investigational Site Number 840565

    Plano, Texas, 75024

  • Investigational Site Number 840413

    Pocatello, Idaho, 83201

  • Investigational Site Number 840582

    Pomona, California, 91767

  • Investigational Site Number 840346

    Port Hueneme, California, 93041

  • Investigational Site Number 840422

    Portland, Oregon, 97201-3098

  • Investigational Site Number 840511

    Portland, Oregon, 97227-1191

  • Investigational Site Number 840266

    Providence, Rhode Island, 02908

  • Investigational Site Number 840481

    Raleigh, North Carolina, 27609

  • Investigational Site Number 840551

    Rapid City, South Dakota, 57701

  • Investigational Site Number 840608

    Richmond, Texas, 77469

  • Investigational Site Number 840001

    Richmond, Virginia, 23219

  • Investigational Site Number 840628

    Ridgewood, New Jersey, 07450

  • Investigational Site Number 840286

    Roanoke, Virginia, 24014

  • Investigational Site Number 840430

    Rockville, Maryland, 20852

  • Investigational Site Number 840696

    Rosedale, New York, 14221

  • Investigational Site Number 840466

    Roseville, California, 95661

  • Investigational Site Number 840573

    San Antonio, Texas, 78258

  • Investigational Site Number 840575

    San Marino, California, 91108

  • Investigational Site Number 840131

    Santa Ana, California, 82705

  • Investigational Site Number 840335

    Santa Ana, California, 92704

  • Investigational Site Number 840178

    Shreveport, Louisiana, 71130

  • Investigational Site Number 840576

    Simi Valley, California, 93065

  • Investigational Site Number 840162

    Somerset, New Jersey, 08873

  • Investigational Site Number 840312

    Southfield, Michigan, 48075

  • Investigational Site Number 840094

    Spokane, Washington, 99207

  • Investigational Site Number 840343

    Spokane, Washington, 99207

  • Investigational Site Number 840268

    Spokane, Washington, 99220

  • Investigational Site Number 840091

    St Louis, Missouri, 63122

  • Investigational Site Number 840046

    St Louis, Missouri, 63128

  • Investigational Site Number 840678

    St Louis, Missouri, 63131

  • Investigational Site Number 840400

    St Louis, Missouri, 63141

  • Investigational Site Number 840056

    St. Petersburg, Florida, 33707

  • Investigational Site Number 840484

    Sterling Heights, Michigan, 48310

  • Investigational Site Number 840564

    Sugarland, Texas, 77479

  • Investigational Site Number 840414

    Sylmar, California, 91342

  • Investigational Site Number 840061

    Tacoma, Washington, 98405

  • Investigational Site Number 840640

    Takoma Park, Maryland, 20912

  • Investigational Site Number 840309

    Taylors, South Carolina, 29687-4105

  • Investigational Site Number 840250

    Tempe, Arizona, 85284

  • Investigational Site Number 840393

    Toney, Alabama, 35773

  • Investigational Site Number 840009

    Topeka, Kansas, 66606

  • Investigational Site Number 840293

    Towson, Maryland, 21204

  • Investigational Site Number 840042

    Tucson, Arizona, 85723

  • Investigational Site Number 840395

    Ventura, California, 93003

  • Investigational Site Number 840206

    Vista, California, 92081-7832

  • Investigational Site Number 840241

    Waco, Texas, 76708

  • Investigational Site Number 840631

    Washington D.C., District of Columbia, 20060

  • Investigational Site Number 840044

    Washington D.C., District of Columbia, 20422

  • Investigational Site Number 840295

    Wellington, Florida, 33449

  • Investigational Site Number 840480

    Westlake Village, California, 91361

  • Investigational Site Number 840350

    Whittier, California, 90602

  • Investigational Site Number 840381

    Wilmington, North Carolina, 28401

  • Investigational Site Number 840532

    Winston-Salem, North Carolina, 27157-1071

Other trials in United States

Russia55 sites

  • Investigational Site Number 643023

    Barnaul, 656055

  • Investigational Site Number 643044

    Kazan', 420012

  • Investigational Site Number 643005

    Kemerovo, 650002

  • Investigational Site Number 643006

    Kemerovo, 650002

  • Investigational Site Number 643061

    Krasnodar, 350063

  • Investigational Site Number 643027

    Krasnodar, 350086

  • Investigational Site Number 643037

    Moscow, 101990

  • Investigational Site Number 643038

    Moscow, 101990

  • Investigational Site Number 643002

    Moscow, 105066

  • Investigational Site Number 643043

    Moscow, 117036

  • Investigational Site Number 643008

    Moscow, 117292

  • Investigational Site Number 643009

    Moscow, 117292

  • Investigational Site Number 643029

    Moscow, 117556

  • Investigational Site Number 643018

    Moscow, 119048

  • Investigational Site Number 643042

    Moscow, 119435

  • Investigational Site Number 643052

    Moscow, 121309

  • Investigational Site Number 643026

    Moscow, 121374

  • Investigational Site Number 643003

    Moscow, 121552

  • Investigational Site Number 643051

    Moscow, 125284

  • Investigational Site Number 643013

    Moscow, 127018

  • Investigational Site Number 643001

    Moscow, 127473

  • Investigational Site Number 643060

    Moscow, 127644

  • Investigational Site Number 643040

    Moscow, 129327

  • Investigational Site Number 643034

    Nizhny Novgorod, 603003

  • Investigational Site Number 643054

    Novosibirsk, 630047

  • Investigational Site Number 643055

    Novosibirsk, 630075

  • Investigational Site Number 643045

    Omsk, 644043

  • Investigational Site Number 643030

    Penza, 440026

  • Investigational Site Number 643017

    Perm, 614077

  • Investigational Site Number 643049

    Perm, 614097

  • Investigational Site Number 643048

    Rostov-on-Don, 344068

  • Investigational Site Number 643047

    Ryazan, 390026

  • Investigational Site Number 643024

    Saint Petersburg, 190000

  • Investigational Site Number 643031

    Saint Petersburg, 192242

  • Investigational Site Number 643035

    Saint Petersburg, 193312

  • Investigational Site Number 643022

    Saint Petersburg, 194044

  • Investigational Site Number 643039

    Saint Petersburg, 194156

  • Investigational Site Number 643057

    Saint Petersburg, 194354

  • Investigational Site Number 643041

    Saint Petersburg, 195257

  • Investigational Site Number 643036

    Saint Petersburg, 197341

  • Investigational Site Number 643011

    Saint Petersburg, 198013

  • Investigational Site Number 643004

    Saint Petersburg, 199106

  • Investigational Site Number 643025

    Saratov, 410028

  • Investigational Site Number 643056

    Saratov, 410028

  • Investigational Site Number 643010

    Saratov, 410030

  • Investigational Site Number 643033

    Saratov, 410039

  • Investigational Site Number 643019

    Saratov, 410054

  • Investigational Site Number 643014

    Smolensk, 214018

  • Investigational Site Number 643028

    Tomsk, 634012

  • Investigational Site Number 643016

    Tver', 170036

  • Investigational Site Number 643012

    Tyumen, 625023

  • Investigational Site Number 643059

    Vladimir, 600020

  • Investigational Site Number 643058

    Voronezh, 394065

  • Investigational Site Number 643020

    Yaroslavl, 150003

  • Investigational Site Number 643062

    Yaroslavl, 150030

Other trials in Russia

Argentina46 sites

  • Investigational Site Number 032028

    Adrogué, B1846DSK

  • Investigational Site Number 032030

    Bahía Blanca, B8000AKK

  • Investigational Site Number 032043

    Bahía Blanca, B8000FTD

  • Investigational Site Number 032054

    Bahía Blanca, B8001HXM

  • Investigational Site Number 032066

    Caba, 1120

  • Investigational Site Number 032049

    Caba, 1440

  • Investigational Site Number 032056

    Caba, C1181ACL

  • Investigational Site Number 032003

    Caba, C1425AGC

  • Investigational Site Number 032017

    Capital Federal, C1056ABJ

  • Investigational Site Number 032009

    Capital Federal, C1179AAB

  • Investigational Site Number 032050

    Cipolletti, 8324

  • Investigational Site Number 032052

    Ciudad Autonoma de Bs.As, 1428

  • Investigational Site Number 032015

    Córdoba, 5000

  • Investigational Site Number 032011

    Córdoba, X50009BSN

  • Investigational Site Number 032022

    Córdoba, X5000AAW

  • Investigational Site Number 032037

    Córdoba, X5000AAX

  • Investigational Site Number 032020

    Coronel Suárez, B7540GHD

  • Investigational Site Number 032004

    Corrientes, 3400

  • Investigational Site Number 032018

    Corrientes, W3410AVV

  • Investigational Site Number 032005

    Godoy Cruz, M5501ARP

  • Investigational Site Number 032042

    Haedo, 1706

  • Investigational Site Number 032019

    Junín, B6000BHA

  • Investigational Site Number 032063

    La Plata, 1900

  • Investigational Site Number 032040

    Lanus, 1824

  • Investigational Site Number 032036

    Mar del Plata, B7600

  • Investigational Site Number 032039

    Mar del Plata, C7600CBM

  • Investigational Site Number 032058

    Mendoza, 5500

  • Investigational Site Number 032038

    Morón, 1708

  • Investigational Site Number 032002

    Paraná, E3100BBJ

  • Investigational Site Number 032023

    Qilmes, b1878dkf

  • Investigational Site Number 032047

    Rafaela, S2300MMA

  • Investigational Site Number 032024

    Ramos Mejía, 1704

  • Investigational Site Number 032006

    Resistencia, H3500CDM

  • Investigational Site Number 032012

    Rosario, 2000CVD

  • Investigational Site Number 032027

    Rosario, S2000DSR

  • Investigational Site Number 032055

    Salta, 4400

  • Investigational Site Number 032065

    Salta, 4400

  • Investigational Site Number 032051

    San Miguel de Tucumán, 4000

  • Investigational Site Number 032008

    San Miguel de Tucumán, T4000ICL

  • Investigational Site Number 032033

    San Nicolás, B2900DMH

  • Investigational Site Number 032045

    Santa Fe, S3000AZG

  • Investigational Site Number 032035

    Santa Fe, S3000FWO

  • Investigational Site Number 032062

    Santa Rosa, L6300DSD

  • Investigational Site Number 032034

    Venado Tuerto, S2600KUE

  • Investigational Site Number 032046

    Villa María, X5900JKA

  • Investigational Site Number 032029

    Zárate, B2800DGH

Other trials in Argentina

United Kingdom31 sites

  • Investigational Site Number 826042

    Antrim, BT41 2RL

  • Investigational Site Number 826002

    Ashton-under-Lyne, OL6 9RW

  • Investigational Site Number 826026

    Barnstaple, EX31 4JB

  • Investigational Site Number 826017

    Bath, BA1 3NG

  • Investigational Site Number 826034

    Birmingham, B9 5SS

  • Investigational Site Number 826052

    Bolton, BL1 4AL

  • Investigational Site Number 826005

    Bradford, BD5 0NA

  • Investigational Site Number 826048

    Carmarthen, SA31 2AF

  • Investigational Site Number 826037

    Chester, CH2 1UL

  • Investigational Site Number 826011

    Dumfries, DG1 4AP

  • Investigational Site Number 826044

    East Kilbride, G75 8RG

  • Investigational Site Number 826023

    Edinburgh, EH3 9YW

  • Investigational Site Number 826008

    Glasgow, G11 6NT

  • Investigational Site Number 826010

    Harrogate, HG2 7SX

  • Investigational Site Number 826040

    Ipswich, IP4 5PD

  • Investigational Site Number 826033

    Larbert, FK5 4WR

  • Investigational Site Number 826027

    Liverpool, L9 7AL

  • Investigational Site Number 826039

    Londonderry, BT47 6SB

  • Investigational Site Number 826036

    Manchester, M13 9WL

  • Investigational Site Number 826021

    Manchester, M23 9LT

  • Investigational Site Number 826006

    Manchester, M8 6RB

  • Investigational Site Number 826049

    Norwich, NR1 3SR

  • Investigational Site Number 826020

    Nuneaton, CV10 7DJ

  • Investigational Site Number 826009

    Oldham, OL1 2JH

  • Investigational Site Number 826007

    Salford, M6 8HD

  • Investigational Site Number 826045

    Stoke-on-Trent, ST4 6QG

  • Investigational Site Number 826038

    Swansea, SA6 6NL

  • Investigational Site Number 826018

    Taunton, TA1 5DA

  • Investigational Site Number 826016

    Truro, TR1 3LJ

  • Investigational Site Number 826046

    Wolverhampton, WV10 0QP

  • Investigational Site Number 826019

    Yeovil, BA21 4AT

Other trials in United Kingdom

Chile29 sites

  • Investigational Site Number 152024

    Antofagasta, 1270001

  • Investigational Site Number 152023

    Concepción, 4070038

  • Investigational Site Number 152041

    Osorno, 5311092

  • Investigational Site Number 152040

    Port Montt, 5480000

  • Investigational Site Number 152038

    Punta Arenas, 6210005

  • Investigational Site Number 152036

    San Felipe, 2172972

  • Investigational Site Number 152035

    Santiago, 285-1950

  • Investigational Site Number 152020

    Santiago, 7500010

  • Investigational Site Number 152028

    Santiago, 7500503

  • Investigational Site Number 152031

    Santiago, 7500520

  • Investigational Site Number 152001

    Santiago, 7500710

  • Investigational Site Number 152034

    Santiago, 7500710

  • Investigational Site Number 152008

    Santiago, 7591047

  • Investigational Site Number 152013

    Santiago, 7591047

  • Investigational Site Number 152019

    Santiago, 7650018

  • Investigational Site Number 152018

    Santiago, 7980378

  • Investigational Site Number 152042

    Santiago, 80004005

  • Investigational Site Number 152015

    Santiago, 8053095

  • Investigational Site Number 152004

    Santiago, 8350595

  • Investigational Site Number 152029

    Santiago, 838-0456

  • Investigational Site Number 152022

    Santiago, 8380456

  • Investigational Site Number 152011

    Santiago, 890-0085

  • Investigational Site Number 152025

    Talca, 9999

  • Investigational Site Number 152014

    Temuco, 4781173

  • Investigational Site Number 152003

    Temuco, 4813299

  • Investigational Site Number 152037

    Valdivia, 5090146

  • Investigational Site Number 152032

    Valparaíso, 234-0207

  • Investigational Site Number 152010

    Viña del Mar, 2570017

  • Investigational Site Number 152002

    Viña del Mar

Other trials in Chile

Mexico28 sites

  • Investigational Site Number 484011

    Acapulco, 39670

  • Investigational Site Number 484008

    Aguascalientes, 20230

  • Investigational Site Number 484033

    Aguascalientes, 20230

  • Investigational Site Number 484016

    Chihuahua City, 31000

  • Investigational Site Number 484023

    Ciudad Madero, 89440

  • Investigational Site Number 484007

    Durango, 34000

  • Investigational Site Number 484001

    Durango, 34080

  • Investigational Site Number 484041

    Durango, 34080

  • Investigational Site Number 484032

    Guadalajara, 44150

  • Investigational Site Number 484034

    Guadalajara, 44160

  • Investigational Site Number 484014

    Guadalajara, 44210

  • Investigational Site Number 484028

    Guadalajara, 44210

  • Investigational Site Number 484021

    Guadalajara, 44670

  • Investigational Site Number 484006

    Guadalajara, 44680

  • Investigational Site Number 484018

    Guadalajara, 45200

  • Investigational Site Number 484024

    León, 37150

  • Investigational Site Number 484026

    Mexico City, 06470

  • Investigational Site Number 484022

    Mexico City, 07300

  • Investigational Site Number 484013

    Mexico City, 14000

  • Investigational Site Number 484003

    Monterrey, 64020

  • Investigational Site Number 484025

    Monterrey, 64060

  • Investigational Site Number 484002

    Monterrey, 64460

  • Investigational Site Number 484005

    Monterrey, 64460

  • Investigational Site Number 484004

    Monterrey, 64620

  • Investigational Site Number 484035

    Morelia, 58260

  • Investigational Site Number 484020

    San Luis Potosí City, 78200

  • Investigational Site Number 484017

    Tlalnepantla, 54055

  • Investigational Site Number 484031

    Xalapa, 91020

Other trials in Mexico

India27 sites

  • Investigational Site Number 356019

    Ahmedabad, 380052

  • Investigational Site Number 356002

    Bangalore, 560043

  • Investigational Site Number 356010

    Bangalore, 560092

  • Investigational Site Number 356026

    Bangalore, 562114

  • Investigational Site Number 356024

    Belagavi, 590001

  • Investigational Site Number 356012

    Chandigarh, 160062

  • Investigational Site Number 356022

    Gūrgaon, 122002

  • Investigational Site Number 356029

    Hubli, 580021

  • Investigational Site Number 356020

    Hyderabad, 500063

  • Investigational Site Number 356031

    Jaipur, 302001

  • Investigational Site Number 356016

    Kochi, 682026

  • Investigational Site Number 356004

    Kolkata

  • Investigational Site Number 356015

    Lucknow, 226003

  • Investigational Site Number 356014

    Lucknow

  • Investigational Site Number 356009

    Ludhiana, 141001

  • Investigational Site Number 356025

    Madurai

  • Investigational Site Number 356032

    Mangalore, 575002

  • Investigational Site Number 356018

    Manipal, 576104

  • Investigational Site Number 356023

    Mysore, 570020

  • Investigational Site Number 356027

    Nagpur, 440010

  • Investigational Site Number 356006

    Nagpur

  • Investigational Site Number 356030

    Nashik, 422002

  • Investigational Site Number 356034

    Nashik, 422005

  • Investigational Site Number 356013

    New Delhi, 110017

  • Investigational Site Number 356017

    New Delhi, 122001

  • Investigational Site Number 356021

    Pune, 411001

  • Investigational Site Number 356028

    Pune, 411019

Other trials in India

Japan25 sites

  • Investigational Site Number 392011

    Chūōku

  • Investigational Site Number 392015

    Fuchu-Shi

  • Investigational Site Number 392012

    Fujisawa-Shi

  • Investigational Site Number 392025

    Hachioji-Shi

  • Investigational Site Number 392027

    Hakusan-Shi

  • Investigational Site Number 392005

    Hamamatsu

  • Investigational Site Number 392022

    Hitachi-Shi

  • Investigational Site Number 392019

    Kawanishi-Shi

  • Investigational Site Number 392013

    Kobe

  • Investigational Site Number 392007

    Matsuyama

  • Investigational Site Number 392008

    Matsuyama

  • Investigational Site Number 392009

    Nagasaki

  • Investigational Site Number 392002

    Noda

  • Investigational Site Number 392020

    Osaka

  • Investigational Site Number 392021

    Osaka

  • Investigational Site Number 392001

    Sapporo

  • Investigational Site Number 392010

    Sapporo

  • Investigational Site Number 392024

    Setagaya-Ku

  • Investigational Site Number 392004

    Shinagawa-Ku

  • Investigational Site Number 392014

    Shirakawa-Shi

  • Investigational Site Number 392018

    Suita-Shi

  • Investigational Site Number 392003

    tabashi City

  • Investigational Site Number 392017

    tabashi City

  • Investigational Site Number 392016

    Tachikawa-Shi

  • Investigational Site Number 392023

    Takasaki-Shi

Other trials in Japan

Brazil22 sites

  • Investigational Site Number 076024

    Belém, 66087-660

  • Investigational Site Number 076006

    Belo Horizonte, 30150-221

  • Investigational Site Number 076012

    Belo Horizonte, 30150-221

  • Investigational Site Number 076021

    Brasília, 70310-500

  • Investigational Site Number 076002

    Campinas, 13015-001

  • Investigational Site Number 076019

    Curitiba, 80730-150

  • Investigational Site Number 076003

    Fortaleza, 60115-282

  • Investigational Site Number 076018

    Fortaleza, 60170-320

  • Investigational Site Number 076004

    Fortaleza, 60430-370

  • Investigational Site Number 076023

    Goiânia, 74823470

  • Investigational Site Number 076014

    Marília, 17515-240

  • Investigational Site Number 076015

    Passo Fundo, 99010-180

  • Investigational Site Number 076008

    Porto Alegre, 90020-090

  • Investigational Site Number 076013

    Porto Alegre, 90035-001

  • Investigational Site Number 076026

    Porto Alegre, 90620-001

  • Investigational Site Number 076025

    Recife, 52051-380

  • Investigational Site Number 076020

    Salvador, 40050-410

  • Investigational Site Number 076016

    São Paulo, 01323-001

  • Investigational Site Number 076010

    São Paulo, 04012-180

  • Investigational Site Number 076001

    São Paulo, 04024-002

  • Investigational Site Number 076005

    São Paulo, 05403-000

  • Investigational Site Number 076007

    Uberlândia, 38400-368

Other trials in Brazil

Romania22 sites

  • Investigational Site Number 642029

    Arad, 310158

  • Investigational Site Number 642020

    Baia Mare, 430123

  • Investigational Site Number 642019

    Brăila, 810249

  • Investigational Site Number 642003

    Brasov, 500365

  • Investigational Site Number 642034

    Bucharest, 010825

  • Investigational Site Number 642022

    Bucharest, 020475

  • Investigational Site Number 642001

    Bucharest, 021392

  • Investigational Site Number 642013

    Bucharest, 050098

  • Investigational Site Number 642026

    Cluj-Napoca, 40001

  • Investigational Site Number 642030

    Craiova, 200147

  • Investigational Site Number 642015

    Craiova, 200642

  • Investigational Site Number 642007

    Deva, 330084

  • Investigational Site Number 642011

    Iași, 700547

  • Investigational Site Number 642010

    Iași, 700732

  • Investigational Site Number 642016

    Oradea, 410598

  • Investigational Site Number 642033

    Piteşti, 110084

  • Investigational Site Number 642002

    Ploieşti, 100097

  • Investigational Site Number 642009

    Suceava, 720262

  • Investigational Site Number 642014

    Târgu Mureş, 540099

  • Investigational Site Number 642012

    Târgu Mureş, 540142

  • Investigational Site Number 642018

    Timișoara, 300174

  • Investigational Site Number 642031

    Timișoara, 300736

Other trials in Romania

Poland20 sites

  • Investigational Site Number 616005

    ?ód?, 91-087

  • Investigational Site Number 616008

    Bialystok, 15-276

  • Investigational Site Number 616019

    Bydgoszcz, 85-046

  • Investigational Site Number 616012

    Czeladź, 41-250

  • Investigational Site Number 616007

    Częstochowa, 42-217

  • Investigational Site Number 616014

    Gdynia, 81-394

  • Investigational Site Number 616013

    Gliwice, 44-100

  • Investigational Site Number 616028

    Grodzisk Mazowiecki, 05-825

  • Investigational Site Number 616022

    Katowice, 40-767

  • Investigational Site Number 616001

    Krakow, 30-082

  • Investigational Site Number 616024

    Krakow, 31-024

  • Investigational Site Number 616029

    Łęczyca, 99-100

  • Investigational Site Number 616023

    Poland, 42-500

  • Investigational Site Number 616021

    Puławy, 24-100

  • Investigational Site Number 616006

    Ruda Śląska, 41-706

  • Investigational Site Number 616025

    Szczecin, 70-506

  • Investigational Site Number 616032

    Warsaw, 00-685

  • Investigational Site Number 616020

    Wroclaw, 50-088

  • Investigational Site Number 616011

    Wroclaw, 50-981

  • Investigational Site Number 616031

    Zgierz, 95-100

Other trials in Poland

China19 sites

  • Investigational Site Number 156016

    Beijing, 100029

  • Investigational Site Number 156034

    Beijing, 100029

  • Investigational Site Number 156024

    Beijing, 100034

  • Investigational Site Number 156028

    Beijing, 100037

  • Investigational Site Number 156014

    Beijing, 100088

  • Investigational Site Number 156005

    Beijing, 100730

  • Investigational Site Number 156006

    Beijing, 100730

  • Investigational Site Number 156001

    Beijing, 100853

  • Investigational Site Number 156008

    Dalian, 116011

  • Investigational Site Number 156020

    Guangzhou, 510080

  • Investigational Site Number 156023

    Jinan, 250012

  • Investigational Site Number 156015

    Jinan, 250013

  • Investigational Site Number 156009

    Nanjing, 210008

  • Investigational Site Number 156013

    Shanghai, 200003

  • Investigational Site Number 156019

    Shanghai, 200080

  • Investigational Site Number 156032

    Shenyang, 110004

  • Investigational Site Number 156022

    Shenyang, 110016

  • Investigational Site Number 156004

    Suzhou, 215006

  • Investigational Site Number 156033

    Ürümqi, 830054

Other trials in China

Colombia19 sites

  • Investigational Site Number 170025

    Armenia

  • Investigational Site Number 170009

    Barranquilla

  • Investigational Site Number 170010

    Barranquilla

  • Investigational Site Number 170002

    Bogotá

  • Investigational Site Number 170005

    Bogotá

  • Investigational Site Number 170012

    Bogotá

  • Investigational Site Number 170014

    Bogotá

  • Investigational Site Number 170022

    Bogotá

  • Investigational Site Number 170004

    Bucaramanga

  • Investigational Site Number 170017

    Cali

  • Investigational Site Number 170024

    Cali

  • Investigational Site Number 170013

    Cartagena

  • Investigational Site Number 170026

    Espinal - Tolima

  • Investigational Site Number 170007

    Floridablanca

  • Investigational Site Number 170008

    Floridablanca

  • Investigational Site Number 170019

    Manizales

  • Investigational Site Number 170003

    Medellín

  • Investigational Site Number 170020

    Medellín

  • Investigational Site Number 170021

    Pereira

Other trials in Colombia

Germany17 sites

  • Investigational Site Number 276003

    Berlin, 13347

  • Investigational Site Number 276022

    Bochum, 44787

  • Investigational Site Number 276005

    Chemnitz, 09111

  • Investigational Site Number 276021

    Dresden, 01067

  • Investigational Site Number 276024

    Dresden, 01099

  • Investigational Site Number 276007

    Elsterwerda, 04910

  • Investigational Site Number 276018

    Frankfurt A.M., 60596

  • Investigational Site Number 276011

    Frankfurt am Main, 60389

  • Investigational Site Number 276017

    Görlitz, 02826

  • Investigational Site Number 276025

    Haßloch, 67454

  • Investigational Site Number 276009

    Heidelberg, 69120

  • Investigational Site Number 276019

    Leipzig, 04103

  • Investigational Site Number 276020

    Magdeburg, 39104

  • Investigational Site Number 276028

    Mühldorf, 84453

  • Investigational Site Number 276014

    Pirna, 01796

  • Investigational Site Number 276016

    Pohlheim, 35415

  • Investigational Site Number 276026

    Rotenburg an der Fulda, 36199

Other trials in Germany

Italy16 sites

  • Investigational Site Number 380024

    Carpi, 41012

  • Investigational Site Number 380004

    Chieri, 10023

  • Investigational Site Number 380002

    Chieti, 66013

  • Investigational Site Number 380006

    Fermo, 63023

  • Investigational Site Number 380010

    Florence, 50141

  • Investigational Site Number 380009

    Genova, 16011

  • Investigational Site Number 380016

    Messina, 98124

  • Investigational Site Number 380023

    Milan, 20122

  • Investigational Site Number 380011

    Milan, 20132

  • Investigational Site Number 380012

    Milan, 20142

  • Investigational Site Number 380014

    Naples, 80131

  • Investigational Site Number 380019

    Novara, 28100

  • Investigational Site Number 380005

    Palermo, 90127

  • Investigational Site Number 380001

    Pisa, 56124

  • Investigational Site Number 380013

    Roma, 00128

  • Investigational Site Number 380020

    Rozzano, 20089

Other trials in Italy

South Africa16 sites

  • Investigational Site Number 710020

    Alberton, 1450

  • Investigational Site Number 710017

    Cape Town, 7405

  • Investigational Site Number 710006

    Cape Town, 7530

  • Investigational Site Number 710010

    Cape Town, 7764

  • Investigational Site Number 710025

    Cape Town, 7925

  • Investigational Site Number 710008

    Chatsworth, 4091

  • Investigational Site Number 710011

    Durban

  • Investigational Site Number 710015

    George, 6529

  • Investigational Site Number 710019

    Kempton Park, 1619

  • Investigational Site Number 710014

    Paarl, 7646

  • Investigational Site Number 710023

    Parow, 7500

  • Investigational Site Number 710002

    Pretoria, 0002

  • Investigational Site Number 710001

    Pretoria, 181

  • Investigational Site Number 710005

    Richards Bay, 3900

  • Investigational Site Number 710007

    Somerset West, 7130

  • Investigational Site Number 710004

    Worcester, 6850

Other trials in South Africa

Peru15 sites

  • Investigational Site Number 604007

    Arequipa, 5154

  • Investigational Site Number 604014

    Callao, CALLAO 2

  • Investigational Site Number 604011

    Lima, 051

  • Investigational Site Number 604019

    Lima, 051

  • Investigational Site Number 604013

    Lima, 11

  • Investigational Site Number 604010

    Lima, 12

  • Investigational Site Number 604002

    Lima, 27

  • Investigational Site Number 604006

    Lima, 27

  • Investigational Site Number 604015

    Lima, 511

  • Investigational Site Number 604016

    Lima, 511

  • Investigational Site Number 604017

    Lima, LIMA 01

  • Investigational Site Number 604018

    Lima, LIMA 11

  • Investigational Site Number 604005

    Lima, LIMA 14

  • Investigational Site Number 604009

    Lima, LIMA 27

  • Investigational Site Number 604001

    Lima, LIMA 31

Other trials in Peru

Spain15 sites

  • Investigational Site Number 724013

    A Coruña, 15006

  • Investigational Site Number 724005

    Alcalá de Henares, 28805

  • Investigational Site Number 724016

    Almería, 04120

  • Investigational Site Number 724012

    Barakaldo, 48903

  • Investigational Site Number 724018

    Barcelona, 08036

  • Investigational Site Number 724014

    Bilbao, 48013

  • Investigational Site Number 724015

    Cáceres, 10003

  • Investigational Site Number 724008

    Lleida, 25198

  • Investigational Site Number 724011

    Madrid, 28046

  • Investigational Site Number 724017

    Murcia, 30120

  • Investigational Site Number 724022

    Oviedo, 33006

  • Investigational Site Number 724003

    Pontevedra, 36071

  • Investigational Site Number 724001

    Seville, 41014

  • Investigational Site Number 724020

    Valencia, 46010

  • Investigational Site Number 724004

    Vigo, 36211

Other trials in Spain

Canada13 sites

  • Investigational Site Number 124024

    Calgary, T2N 4N1

  • Investigational Site Number 124016

    Cambridge, N1R 7Z6

  • Investigational Site Number 124026

    Edmonton, T6G 2B7

  • Investigational Site Number 124005

    Greater Sudbury, P3C 5K7

  • Investigational Site Number 124001

    Laval, H7T 2P5

  • Investigational Site Number 124021

    Montreal, H1T 1C8

  • Investigational Site Number 124006

    Montreal, H3Z 1E5

  • Investigational Site Number 124027

    Oshawa, L1J 2J9

  • Investigational Site Number 124025

    Québec, G1V 4G5

  • Investigational Site Number 124028

    Red Deer, T4N 6V7

  • Investigational Site Number 124003

    Saint-Marc-des-Carrieres, G0A 4B0

  • Investigational Site Number 124007

    Sarnia, N7T 4R9

  • Investigational Site Number 124002

    Thetford-Mines, G6G 2V4

Other trials in Canada

South Korea12 sites

  • Investigational Site Number 410012

    Bucheon-si, 420-767

  • Investigational Site Number 410006

    Daegu, 705-717

  • Investigational Site Number 410009

    Gwangju, 501-757

  • Investigational Site Number 410008

    Incheon, 400-711

  • Investigational Site Number 410001

    Incheon, 405-760

  • Investigational Site Number 410004

    Seongnam, 463-707

  • Investigational Site Number 410014

    Seoul, 110-744

  • Investigational Site Number 410013

    Seoul, 134-727

  • Investigational Site Number 410002

    Seoul, 135-720

  • Investigational Site Number 410011

    Seoul, 152-703

  • Investigational Site Number 410010

    Seoul, 156-755

  • Investigational Site Number 410007

    Wŏnju, 220-701

Other trials in South Korea

Ukraine12 sites

  • Investigational Site Number 804004

    Chernivtsi, 58022

  • Investigational Site Number 804006

    Dnipro, 49023

  • Investigational Site Number 804002

    Dnipropetrovsk, 49006

  • Investigational Site Number 804009

    Kharkiv, 61022

  • Investigational Site Number 804010

    Kharkiv, 61176

  • Investigational Site Number 804003

    Kiev, 02091

  • Investigational Site Number 804011

    Kiev, 02660

  • Investigational Site Number 804012

    Kyiv, 03680

  • Investigational Site Number 804013

    Kyiv, 04114

  • Investigational Site Number 804005

    Lviv, 79015

  • Investigational Site Number 804007

    Odesa, 65025

  • Investigational Site Number 804008

    Odesa, 65059

Other trials in Ukraine

Bulgaria11 sites

  • Investigational Site Number 100002

    Byala, 7100

  • Investigational Site Number 100011

    Gabrovo, 5300

  • Investigational Site Number 100001

    Kazanlak, 6100

  • Investigational Site Number 100006

    Lovech, 5500

  • Investigational Site Number 100004

    Pleven, 5800

  • Investigational Site Number 100003

    Plovdiv, 4002

  • Investigational Site Number 100007

    Plovdiv, 4002

  • Investigational Site Number 100016

    Sandanski, 2800

  • Investigational Site Number 100010

    Sofia, 1606

  • Investigational Site Number 100015

    Sofia, 1618

  • Investigational Site Number 100005

    Varna, 9000

Other trials in Bulgaria

Denmark11 sites

  • Investigational Site Number 208003

    Aarhus, 8000

  • Investigational Site Number 208009

    Aarhus C, 8000

  • Investigational Site Number 208011

    Esbjerg, 6700

  • Investigational Site Number 208004

    Farsø, 9640

  • Investigational Site Number 208002

    Hellerup, 2900

  • Investigational Site Number 208010

    Herlev, 2730

  • Investigational Site Number 208008

    Hillerød, 3400

  • Investigational Site Number 208006

    Hvidovre, 2650

  • Investigational Site Number 208001

    København NV, 2400

  • Investigational Site Number 208007

    København Ø, 2100

  • Investigational Site Number 208005

    København S, 2300

Other trials in Denmark

Israel11 sites

  • Investigational Site Number 376010

    Afula, 18101

  • Investigational Site Number 376006

    Giv‘atayim, 53583

  • Investigational Site Number 376002

    Haifa, 31096

  • Investigational Site Number 376008

    Haifa, 35251

  • Investigational Site Number 376001

    Holon, 58100

  • Investigational Site Number 376012

    Jerusalem, 91120

  • Investigational Site Number 376011

    Nahariya, 22100

  • Investigational Site Number 376005

    Safed, 13100

  • Investigational Site Number 376004

    Tel Aviv, 64239

  • Investigational Site Number 376003

    Tel HaShomer, 52621

  • Investigational Site Number 376009

    Tzrifin, 70300

Other trials in Israel

Turkey (Türkiye)11 sites

  • Investigational Site Number 792004

    Ankara, 06110

  • Investigational Site Number 792002

    Ankara, 06490

  • Investigational Site Number 792012

    Ankara

  • Investigational Site Number 792001

    Capa / Istanbul, 34390

  • Investigational Site Number 792015

    Istanbul, 34010

  • Investigational Site Number 792008

    Istanbul, 34034

  • Investigational Site Number 792014

    Istanbul, 34385

  • Investigational Site Number 792003

    Izmir, 35100

  • Investigational Site Number 792007

    Izmir, 35100

  • Investigational Site Number 792011

    Mersin, 33169

  • Investigational Site Number 792013

    Samsun, 55200

Other trials in Turkey (Türkiye)

Guatemala10 sites

  • Investigational Site Number 320004

    Guatemala City, 01010

  • Investigational Site Number 320006

    Guatemala City, 01010

  • Investigational Site Number 320012

    Guatemala City, 01010

  • Investigational Site Number 320014

    Guatemala City, 01010

  • Investigational Site Number 320001

    Guatemala City, 01014

  • Investigational Site Number 320002

    Guatemala City, 01014

  • Investigational Site Number 320007

    Guatemala City, 01014

  • Investigational Site Number 320008

    Guatemala City, 01014

  • Investigational Site Number 320011

    Guatemala City, 01015

  • Investigational Site Number 320015

    Quetzaltenango, 09001

Other trials in Guatemala

Serbia10 sites

  • Investigational Site Number 688002

    Belgrade, 11000

  • Investigational Site Number 688003

    Belgrade, 11000

  • Investigational Site Number 688004

    Belgrade, 11000

  • Investigational Site Number 688006

    Belgrade, 11000

  • Investigational Site Number 688008

    Belgrade, 11000

  • Investigational Site Number 688009

    Belgrade, 11000

  • Investigational Site Number 688010

    Belgrade, 11000

  • Investigational Site Number 688001

    Belgrade, 11040

  • Investigational Site Number 688005

    Niš, 18000

  • Investigational Site Number 688007

    Niš, 18000

Other trials in Serbia

France9 sites

  • Investigational Site Number 250008

    Brest, 29610

  • Investigational Site Number 250002

    Corbeil-Essonnes, 91109

  • Investigational Site Number 250005

    Nantes, 44093

  • Investigational Site Number 250014

    Nîmes, 30029

  • Investigational Site Number 250007

    Paris, 75908

  • Investigational Site Number 250011

    Pessac, 33600

  • Investigational Site Number 250012

    Poitiers, 86021

  • Investigational Site Number 250006

    Rennes, 35700

  • Investigational Site Number 250001

    Toulouse, 31403

Other trials in France

Philippines8 sites

  • Investigational Site Number 608006

    Cavite

  • Investigational Site Number 608009

    Iligan City, Lanao Del Norte, 9200

  • Investigational Site Number 608003

    Makati City

  • Investigational Site Number 608001

    Manila, 1008

  • Investigational Site Number 608007

    Manila

  • Investigational Site Number 608005

    Marikina City, 1800

  • Investigational Site Number 608002

    Pasay, 1300

  • Investigational Site Number 608008

    Quezon City, 1109

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Taiwan8 sites

  • Investigational Site Number 158005

    Chiayi City, 60002

  • Investigational Site Number 158004

    Taichung, 402

  • Investigational Site Number 158006

    Tainan Hsien, 710

  • Investigational Site Number 158002

    Taipei, 100

  • Investigational Site Number 158007

    Taipei, 111

  • Investigational Site Number 158001

    Taipei, 112

  • Investigational Site Number 158008

    Taipei, 220

  • Investigational Site Number 158003

    Taipei Hsien, 23137

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Latvia7 sites

  • Investigational Site Number 428005

    Cēsis, LV-4101

  • Investigational Site Number 428001

    Daugavpils, LV-5417

  • Investigational Site Number 428002

    Liepāja, LV-3414

  • Investigational Site Number 428003

    Riga, LV-1002

  • Investigational Site Number 428007

    Riga, LV-1011

  • Investigational Site Number 428004

    Riga, LV-1038

  • Investigational Site Number 428006

    Sigulda, LV-2150

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Netherlands7 sites

  • Investigational Site Number 528005

    Alkmaar, 1815 JD

  • Investigational Site Number 528008

    Deventer, 7416 SE

  • Investigational Site Number 528004

    Hoorn, 1625 HV

  • Investigational Site Number 528001

    Rotterdam, 3045 PM

  • Investigational Site Number 528007

    The Hague, 2597 AX

  • Investigational Site Number 528003

    Tilburg, 5022 GC

  • Investigational Site Number 528006

    Venlo, 5912 BL

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Sweden7 sites

  • Investigational Site Number 752012

    Karlstad, 651 85

  • Investigational Site Number 752011

    Kristianstad, 29185

  • Investigational Site Number 752006

    Ljungby, 341 82

  • Investigational Site Number 752009

    Oskarshamn, 572 28

  • Investigational Site Number 752004

    Stockholm, 118 83

  • Investigational Site Number 752007

    Stockholm, 182 88

  • Investigational Site Number 752002

    Vaxjo, 351 85

Other trials in Sweden

Australia6 sites

  • Investigational Site Number 036015

    Epping, 3076

  • Investigational Site Number 036001

    Fremantle, 6160

  • Investigational Site Number 036009

    Geelong, 3220

  • Investigational Site Number 036011

    Perth, 6000

  • Investigational Site Number 036005

    St Leonards, 2065

  • Investigational Site Number 036016

    Townsville, 4810

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Estonia6 sites

  • Investigational Site Number 233004

    Tallinn, 10138

  • Investigational Site Number 233002

    Tallinn, 13415

  • Investigational Site Number 233001

    Tallinn, 13419

  • Investigational Site Number 233003

    Tallinn, 13419

  • Investigational Site Number 233005

    Tartu, 50406

  • Investigational Site Number 233006

    Viljandimaa, 71024

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Finland6 sites

  • Investigational Site Number 246005

    Jyväskylä, 40620

  • Investigational Site Number 246003

    Rauma, 26100

  • Investigational Site Number 246010

    Tampere, 33520

  • Investigational Site Number 246009

    Turku, FIN-20520

  • Investigational Site Number 246007

    Valkeakoski, 37600

  • Investigational Site Number 246012

    Vantaa, 01600

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Lithuania6 sites

  • Investigational Site Number 440003

    Kaunas, LT-49456

  • Investigational Site Number 440002

    Kaunas, LT-50009

  • Investigational Site Number 440004

    Klaipėda, LT-91131

  • Investigational Site Number 440006

    Klaipėda, LT-92304

  • Investigational Site Number 440005

    Panevezys, LT-37355

  • Investigational Site Number 440001

    Vilnius, LT-08661

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Portugal5 sites

  • Investigational Site Number 620005

    Amadora, 2720-276

  • Investigational Site Number 620003

    Coimbra, 3000-075

  • Investigational Site Number 620001

    Lisbon, 1349-019

  • Investigational Site Number 620007

    Penafiel, 4564-007

  • Investigational Site Number 620006

    Porto, 4200

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Tunisia5 sites

  • Investigational Site Number 788003

    Sfax, 3029

  • Investigational Site Number 788005

    Tunis, 1006

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    Tunis, 1007

  • Investigational Site Number 788002

    Tunis, 1008

  • Investigational Site Number 788001

    Tunis, 1027

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Georgia4 sites

  • Investigational Site Number 268003

    Batumi

  • Investigational Site Number 268004

    Kutaisi

  • Investigational Site Number 268001

    Tbilisi

  • Investigational Site Number 268002

    Tbilisi

Other trials in Georgia

Panama4 sites

  • Investigational Site Number 591001

    Cuidad de Panama

  • Investigational Site Number 591003

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  • Investigational Site Number 591004

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  • Investigational Site Number 591002

    Penonomé

Other trials in Panama

Belarus3 sites

  • Investigational Site Number 112002

    Minsk, 220036

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    Minsk, 220096

  • Investigational Site Number 112001

    Minsk, 220116

Other trials in Belarus

Ecuador3 sites

  • Investigational Site Number 218001

    Guayaquil, EC090112

  • Investigational Site Number 218005

    Guayaquil, EC09112

  • Investigational Site Number 218002

    Quito, EC090112

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Norway3 sites

  • Investigational Site Number 578003

    Bodø, 8092

  • Investigational Site Number 578002

    Haugesund, 5528

  • Investigational Site Number 578001

    Stavanger, 4095

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Austria2 sites

  • Investigational Site Number 040002

    Graz, 8036

  • Investigational Site Number 040001

    Vienna, 1160

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Belgium2 sites

  • Investigational Site Number 056001

    Brussels, 1200

  • Investigational Site Number 056003

    Leuven, 3000

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Egypt2 sites

  • Investigational Site Number 818002

    Alexandria

  • Investigational Site Number 818001

    Cairo

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United Arab Emirates2 sites

  • Investigational Site Number 784001

    Abu Dhabi, 51900

  • Investigational Site Number 784002

    Dubai, 4545

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Switzerland1 site

  • Investigational Site Number 756003

    Lugano, 6900

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About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome

Primary Objective:

  • To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome (ACS) event.
Read more

Secondary Objectives:

To demonstrate that when compared to placebo, lixisenatide can reduce:

  • composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure.
  • composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure.
  • urinary albumin excretion (based on the urinary albumin/creatinine ratio).

To assess the safety and tolerability of lixisenatide.

Read the detailed description

The estimated maximum study duration for the first randomized participant was approximately 204 weeks (± 14 days), with a median follow-up over all participants of approximately 91 weeks, broken down as follows:

  • placebo-run-in period: 7 days (+ 3 days)
  • double-blind study treatment period: 203 weeks (± 14 days) (with about a 37 months of recruitment period)
  • post-treatment follow-up period: 3 days (± 1 day)

All participants were followed from randomization until the end of study, which should occur when the last randomized participant had been followed for approximately 10 months. The actual end date of the study was "event driven" and the study end when there were approximately 844 positively-adjudicated primary cardiovascular outcome events.

Being tested
Lixisenatide (AVE0010), Placebo
Medical subject headings
Acute Coronary Syndrome

What participants receive

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

  • Lixisenatide (AVE0010)Drug

    Also called Lyxumia

    Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast using self-injector pen device (Opticlik®). If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 15 or 10 mcg.

  • PlaceboDrug

    Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.

Study groups in NCT01147250
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo matched to lixisenatide once daily (QD) up to end of treatment.
Receives: Drug: Placebo
LixisenatideExperimentalLixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment.
Receives: Drug: Lixisenatide (AVE0010)

What is being measured

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

  1. Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina

    Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.

    Measured: From randomization up to the end of study (median follow-up of 25 months)

Secondary outcomes (3)

  1. Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure

    All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.

    Measured: From randomization up to the end of study (median follow-up of 25 months)

  2. Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure

    All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.

    Measured: From randomization up to the end of study (median follow-up of 25 months)

  3. Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108

    Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.

    Measured: Baseline to Week 108 (LOCF)

Timeline

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

  1. First posted22 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
6,068 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01147250
Sponsor's protocol ID
EFC11319
Other IDs
2009-012852-26, U1111-1116-5558, 2009
Acronym
ELIXA
Status last verified
Oct 2016
First submitted
17 Jun 2010
Last updated
20 Dec 2016
Data monitoring committee
Yes

Publications

  • Bentley-Lewis R, Aguilar D, Riddle MC, Claggett B, Diaz R, Dickstein K, Gerstein HC, Johnston P, Kober LV, Lawson F, Lewis EF, Maggioni AP, McMurray JJ, Ping L, Probstfield JL, Solomon SD, Tardif JC, Wu Y, Pfeffer MA; ELIXA Investigators. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015 May;169(5):631-638.e7. doi: 10.1016/j.ahj.2015.02.002. Epub 2015 Feb 12.

    PubMed 25965710

  • Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJ, Probstfield JL, Riddle MC, Solomon SD, Tardif JC; ELIXA Investigators. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57. doi: 10.1056/NEJMoa1509225.

    PubMed 26630143

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PubMed 39963952

  • Gerstein HC, Wolsk E, Claggett B, Diaz R, Dickstein K, Hess S, Kober L, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Pfeffer MA. Effect of lixisenatide on natriuretic peptides in people with type 2 diabetes and recent acute coronary syndrome: The ELIXA trial. Diabetes Obes Metab. 2023 Apr;25(4):1125-1129. doi: 10.1111/dom.14954. Epub 2023 Jan 3. No abstract available.

    PubMed 36546588

  • Gerstein HC, Hess S, Claggett B, Dickstein K, Kober L, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Pfeffer MA. Protein Biomarkers and Cardiovascular Outcomes in People With Type 2 Diabetes and Acute Coronary Syndrome: The ELIXA Biomarker Study. Diabetes Care. 2022 Sep 1;45(9):2152-2155. doi: 10.2337/dc22-0453.

    PubMed 35817031

  • Wijkman MO, Claggett B, Diaz R, Gerstein HC, Kober L, Lewis E, Maggioni AP, Wolsk E, Aguilar D, Bentley-Lewis R, McMurray JJ, Probstfield J, Riddle M, Tardif JC, Solomon SD, Pfeffer MA. Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial. Cardiovasc Diabetol. 2020 Oct 12;19(1):175. doi: 10.1186/s12933-020-01150-0.

    PubMed 33046070

  • Shin SH, Claggett B, Pfeffer MA, Skali H, Liu J, Aguilar D, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Solomon SD; ELIXA Investigators. Hyperglycaemia, ejection fraction and the risk of heart failure or cardiovascular death in patients with type 2 diabetes and a recent acute coronary syndrome. Eur J Heart Fail. 2020 Jul;22(7):1133-1143. doi: 10.1002/ejhf.1790. Epub 2020 Mar 25.

    PubMed 32212368

  • Seferovic JP, Bentley-Lewis R, Claggett B, Diaz R, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Pfeffer MA. Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration. J Diabetes Res. 2018 Dec 16;2018:1631263. doi: 10.1155/2018/1631263. eCollection 2018.

    PubMed 30648112

  • Muskiet MHA, Tonneijck L, Huang Y, Liu M, Saremi A, Heerspink HJL, van Raalte DH. Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):859-869. doi: 10.1016/S2213-8587(18)30268-7. Epub 2018 Oct 3.

    PubMed 30292589

  • Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.

    PubMed 29693361

  • Wolsk E, Claggett B, Pfeffer MA, Diaz R, Dickstein K, Gerstein HC, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Kober L. Role of B-Type Natriuretic Peptide and N-Terminal Prohormone BNP as Predictors of Cardiovascular Morbidity and Mortality in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. J Am Heart Assoc. 2017 May 29;6(6):e004743. doi: 10.1161/JAHA.116.004743.

    PubMed 28554908

  • Wohlfart P, Linz W, Hubschle T, Linz D, Huber J, Hess S, Crowther D, Werner U, Ruetten H. Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies. J Transl Med. 2013 Mar 28;11:84. doi: 10.1186/1479-5876-11-84.

    PubMed 23537041

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lixisenatide (AVE0010) in people with Acute Coronary Syndrome, run by Sanofi at 829 sites in 49 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 829 sites in United States, Russia, Argentina, United Kingdom, Chile and 44 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 14 Oct 2016). 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?

Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina (time frame: From randomization up to the end of study (median follow-up of 25 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 NCT01147250, which also lists 12 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 20 Dec 2016.

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