AzTrials
AzTrials

Acute Coronary SyndromePhase 3SOLID-TIMI 52NCT01000727

The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial

A Phase 3 study testing Darapladib 160 mg and Standard Therapy in people with Acute Coronary Syndrome, run by GlaxoSmithKline at 914 sites in 36 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

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g. medical procedures performed to restore the normal blood flow in patients with atherosclerosis)) when treatment is started within 30 days after an… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Darapladib 160 mg and Standard Therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13,026 participants
Where
914 sitesin 36 countries
Study dates
1 Dec 2009to 24 Apr 2014
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

  • Signed written informed consent.
  • Men or women at least 18 years old (in Taiwan, at least 20 years old). Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
  • Hospitalization for acute coronary syndrome (ACS) within 30 days prior to study entry.
  • Clinically stable for 24 hours prior to study entry.
  • A planned percutaneous coronary intervention (PCI) should be performed prior to study entry, whenever possible.
  • At least one of the following:
Show all 11Show fewer
  • At least 60 years old.
  • Myocardial infarction prior to the qualifying ACS event.
  • Diabetes mellitus requiring treatment with medication.
  • Diagnosed mild or moderate reduction in kidney function.
  • Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral artery disease.

Who cannot join

  • ACS symptoms or lab results not believed to be caused by a narrowing or blocked coronary artery.
  • No major coronary artery with a blockage of more than 50% (unless all stenoses are successfully treated by PCI).
  • Planned coronary artery bypass graft (CABG) surgery, or CABG surgery performed after the qualifying ACS event and prior to study entry.
  • Certain types of liver disease.
  • Severe reduction in kidney function OR removal of a kidney OR kidney transplant.
  • Severe heart failure.
Show all 18Show fewer
  • Blood pressure higher than normal despite lifestyle changes and treatment with medications.
  • Any life-threatening disease with a life expectancy of less than 2 years (other than heart disease) that may prevent the subject from completing the study.
  • Severe asthma that is poorly controlled with medication.
  • Pregnancy (Note: A pregnancy test will be performed on all non-sterile women prior to study entry).
  • Previous severe allergic reaction to food, medications, drink, insect stings, etc.
  • Drug or alcohol abuse within the past 6 months. Mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.
  • Certain medications that may interfere with the study medication (these will be identified by the study doctor).
  • If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less than or equal to 20.0 nmol/min/mL are excluded.
  • Previously took darapladib (SB-480848).
  • Participation in a study of an investigational medication within the past 30 days.
  • Current participation in a study of an investigational device.
  • Any other reason the investigator deems the subject should not participate in the study.

Trial locations and contacts

914 sites in 36 countries.

914 sites in 36 countries

United States290 sites

  • GSK Investigational Site

    Albany, New York, 12211

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131-0001

  • GSK Investigational Site

    Alexandria, Louisiana, 71301

  • GSK Investigational Site

    Allentown, Pennsylvania, 18103

  • GSK Investigational Site

    Amarillo, Texas, 79106

  • GSK Investigational Site

    Anchorage, Alaska, 99508

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109

  • GSK Investigational Site

    Asheville, North Carolina, 28803

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Atlantis, Florida, 33462

  • GSK Investigational Site

    Augusta, Georgia, 30901

  • GSK Investigational Site

    Aurora, Illinois, 60504

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Avon, Indiana, 46123

  • GSK Investigational Site

    Ayer, Massachusetts, 01432

  • GSK Investigational Site

    Bakersfield, California, 93308

  • GSK Investigational Site

    Bakersfield, California, 93309

  • GSK Investigational Site

    Baltimore, Maryland, 21201

  • GSK Investigational Site

    Baltimore, Maryland, 21208

  • GSK Investigational Site

    Baltimore, Maryland, 21218

  • GSK Investigational Site

    Baltimore, Maryland, 21229

  • GSK Investigational Site

    Baltimore, Maryland, 21236

  • GSK Investigational Site

    Bangor, Maine, 04401

  • GSK Investigational Site

    Bannockburn, Illinois, 60015

  • GSK Investigational Site

    Beaver, Pennsylvania, 15009

  • GSK Investigational Site

    Bel Air, Maryland, 21014

  • GSK Investigational Site

    Bellevue, Washington, 98004

  • GSK Investigational Site

    Bellingham, Washington, 98225

  • GSK Investigational Site

    Beloit, Wisconsin, 53511

  • GSK Investigational Site

    Bethlehem, Pennsylvania, 18015

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Birmingham, Alabama, 35243

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Boise, Idaho, 83712

  • GSK Investigational Site

    Boston, Massachusetts, 02111

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Brandon, Florida, 33511

  • GSK Investigational Site

    Bridgeport, Connecticut, 06606

  • GSK Investigational Site

    Bridgeport, Connecticut, 06610

  • GSK Investigational Site

    Brooklyn, New York, 11219

  • GSK Investigational Site

    Browns Mills, New Jersey, 08015

  • GSK Investigational Site

    Buffalo, New York, 14215

  • GSK Investigational Site

    Burien, Washington, 98166

  • GSK Investigational Site

    Burlington, North Carolina, 27215

  • GSK Investigational Site

    Camp Hill, Pennsylvania, 17011

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Chambersburg, Pennsylvania, 17201

  • GSK Investigational Site

    Charleston, South Carolina, 29401

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Charlotte, North Carolina, 28204

  • GSK Investigational Site

    Chattanooga, Tennessee, 37404

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Cincinnati, Ohio, 45267

  • GSK Investigational Site

    Clearwater, Florida, 33756

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Colorado Springs, Colorado, 80920

  • GSK Investigational Site

    Columbia, Maryland, 21044

  • GSK Investigational Site

    Columbia, Missouri, 65212

  • GSK Investigational Site

    Columbia, South Carolina, 29204

  • GSK Investigational Site

    Columbia, Tennessee, 38401

  • GSK Investigational Site

    Columbia Falls, Montana, 65201

  • GSK Investigational Site

    Concord, North Carolina, 28025

  • GSK Investigational Site

    Corpus Christi, Texas, 78404

  • GSK Investigational Site

    Cottonwood, Arizona, 86326

  • GSK Investigational Site

    Crestview Hills, Kentucky, 41017

  • GSK Investigational Site

    Cumming, Georgia, 30041

  • GSK Investigational Site

    Dallas, Texas, 75226

  • GSK Investigational Site

    Dallas, Texas, 75390-8887

  • GSK Investigational Site

    Dayton, Ohio, 45414

  • GSK Investigational Site

    Daytona Beach, Florida, 32114

  • GSK Investigational Site

    Daytona Beach, Florida, 32117

  • GSK Investigational Site

    Dearborn, Michigan, 48124

  • GSK Investigational Site

    Detroit, Michigan, 48201

  • GSK Investigational Site

    Doylestown, Pennsylvania, 18901

  • GSK Investigational Site

    Duluth, Minnesota, 55805

  • GSK Investigational Site

    Elizabeth, New Jersey, 07202

  • GSK Investigational Site

    Elmer, New Jersey, 8318

  • GSK Investigational Site

    Elyria, Ohio, 44035

  • GSK Investigational Site

    Erie, Pennsylvania, 16502

  • GSK Investigational Site

    Everett, Washington, 98201

  • GSK Investigational Site

    Fairfield, Ohio, 45014

  • GSK Investigational Site

    Fairview Park, Ohio, 44126

  • GSK Investigational Site

    Fall River, Massachusetts, 02720

  • GSK Investigational Site

    Fleming Island, Florida, 32003

  • GSK Investigational Site

    Flint, Michigan, 48532

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Fort Smith, Arkansas, 72903

  • GSK Investigational Site

    Fort Wayne, Indiana, 46804

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Fresno, California, 93721

  • GSK Investigational Site

    Gainesville, Florida, 32610

  • GSK Investigational Site

    Galveston, Texas, 77555-0553

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Glendale, Arizona, 85306

  • GSK Investigational Site

    Glendale, California, 91204

  • GSK Investigational Site

    Golden, Colorado, 80401

  • GSK Investigational Site

    Grand Forks, North Dakota, 58201

  • GSK Investigational Site

    Grand Island, Nebraska, 68803

  • GSK Investigational Site

    Great Falls, Montana, 59405

  • GSK Investigational Site

    Greeley, Colorado, 80631

  • GSK Investigational Site

    Green Bay, Wisconsin, 54301

  • GSK Investigational Site

    Greensboro, North Carolina, 27401

  • GSK Investigational Site

    Greenville, South Carolina, 29607

  • GSK Investigational Site

    Guilford, Connecticut, 06437

  • GSK Investigational Site

    Gulf Breeze, Florida, 32561

  • GSK Investigational Site

    Haddon Heights, New Jersey, 08035

  • GSK Investigational Site

    Hammond, Indiana, 46320

  • GSK Investigational Site

    Harker Heights, Texas, 76548

  • GSK Investigational Site

    Hartford, Connecticut, 06067

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Houston, Texas, 77002

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77090

  • GSK Investigational Site

    Houston, Texas, 77124

  • GSK Investigational Site

    Huntersville, North Carolina, 28078

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Indianapolis, Indiana, 46237

  • GSK Investigational Site

    Indianapolis, Indiana, 46290

  • GSK Investigational Site

    Inverness, Florida, 34452

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Jackson, Tennessee, 38085

  • GSK Investigational Site

    Jackson, Tennessee, 38301

  • GSK Investigational Site

    Jacksonville, Florida, 32207

  • GSK Investigational Site

    Jacksonville, Florida, 32209

  • GSK Investigational Site

    Jacksonville, Florida, 32216

  • GSK Investigational Site

    Jacksonville Beach, Florida, 32250

  • GSK Investigational Site

    Jenkintown, Pennsylvania, 19046

  • GSK Investigational Site

    Jersey Shore, Pennsylvania, 17740

  • GSK Investigational Site

    Johnson City, Tennessee, 37604

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Joplin, Missouri, 64804

  • GSK Investigational Site

    Jupiter, Florida, 33458

  • GSK Investigational Site

    Kalamazoo, Michigan, 49048

  • GSK Investigational Site

    Kalispell, Montana, 59901

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    Katy, Texas, 77493

  • GSK Investigational Site

    Kingwood, Texas, 77339

  • GSK Investigational Site

    Kirkland, Washington, 98034

  • GSK Investigational Site

    Kissimmee, Florida, 34741

  • GSK Investigational Site

    La Mesa, California, 91942

  • GSK Investigational Site

    Lafayette, Louisiana, 70506

  • GSK Investigational Site

    Lake Charles, Louisiana, 70601

  • GSK Investigational Site

    Lancaster, Pennsylvania, 17604

  • GSK Investigational Site

    Lansdale, Pennsylvania, 19446

  • GSK Investigational Site

    Las Vegas, Nevada, 89103

  • GSK Investigational Site

    Leetsdale, Pennsylvania, 15056

  • GSK Investigational Site

    Lewiston, Maine, 04240

  • GSK Investigational Site

    Lexington, Kentucky, 40536-0294

  • GSK Investigational Site

    Lincoln, Nebraska, 68526

  • GSK Investigational Site

    Linden, New Jersey, 07036

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Littleton, Colorado, 80120

  • GSK Investigational Site

    Lomita, California, 90717

  • GSK Investigational Site

    Lorain, Ohio, 44053

  • GSK Investigational Site

    Los Alamitos, California, 90720

  • GSK Investigational Site

    Los Angeles, California, 90015

  • GSK Investigational Site

    Los Angeles, California, 90073

  • GSK Investigational Site

    Louisville, Kentucky, 40205

  • GSK Investigational Site

    Louisville, Kentucky, 40207

  • GSK Investigational Site

    Lynchburg, Virginia, 24501

  • GSK Investigational Site

    Madison, Wisconsin, 53713

  • GSK Investigational Site

    Mansfield, Ohio, 44906

  • GSK Investigational Site

    Marquette, Michigan, 49855

  • GSK Investigational Site

    Matthews, North Carolina, 28105

  • GSK Investigational Site

    Melrose Park, Illinois, 60160

  • GSK Investigational Site

    Middleburg Heights, Ohio, 44130

  • GSK Investigational Site

    Midlothian, Virginia, 23114

  • GSK Investigational Site

    Midwest City, Oklahoma, 73110

  • GSK Investigational Site

    Minneapolis, Minnesota, 55426

  • GSK Investigational Site

    Miramar, Florida, 33025

  • GSK Investigational Site

    Mission Hills, California, 91345

  • GSK Investigational Site

    Mobile, Alabama, 36604

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Mokena, Illinois, 60448

  • GSK Investigational Site

    Monroe, North Carolina, 28112

  • GSK Investigational Site

    Muncie, Indiana, 47303

  • GSK Investigational Site

    Munster, Indiana, 46321

  • GSK Investigational Site

    Nashville, Tennessee, 37205

  • GSK Investigational Site

    New York, New York, 10001

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    New York, New York, 10021

  • GSK Investigational Site

    North Chicago, Illinois, 60064

  • GSK Investigational Site

    Oak Ridge, Tennessee, 37830

  • GSK Investigational Site

    Oakbrook Terrace, Illinois, 60181

  • GSK Investigational Site

    Oakbrook Terrace, Ohio, 60181

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Palm Beach Gardens, Florida, 33410

  • GSK Investigational Site

    Papillion, Nebraska, 68046

  • GSK Investigational Site

    Park Ridge, Illinois, 60068

  • GSK Investigational Site

    Paterson, New Jersey, 07503

  • GSK Investigational Site

    Peekskill, New York, 10567

  • GSK Investigational Site

    Pensacola, Florida, 32501

  • GSK Investigational Site

    Peoria, Illinois, 61614

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19141

  • GSK Investigational Site

    Pinehurst, North Carolina, 28374

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15240

  • GSK Investigational Site

    Plantation, Florida, 33317

  • GSK Investigational Site

    Pomona, New Jersey, 8240

  • GSK Investigational Site

    Pontiac, Michigan, 48341-2985

  • GSK Investigational Site

    Port Charlotte, Florida, 33952

  • GSK Investigational Site

    Portland, Oregon, 97220

  • GSK Investigational Site

    Portland, Oregon, 97239

  • GSK Investigational Site

    Raleigh, North Carolina, 27610

  • GSK Investigational Site

    Rapid City, South Dakota, 57701

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Richmond, Virginia, 23294

  • GSK Investigational Site

    Richmond, Virginia, 23298

  • GSK Investigational Site

    Robbinsdale, Minnesota, 55422

  • GSK Investigational Site

    Rock Island, Illinois, 61201

  • GSK Investigational Site

    Rocky Mount, North Carolina, 27804

  • GSK Investigational Site

    Roseville, California, 95661

  • GSK Investigational Site

    Roslyn, New York, 11576

  • GSK Investigational Site

    Round Rock, Texas, 78681

  • GSK Investigational Site

    Sacramento, California, 95819

  • GSK Investigational Site

    Safety Harbor, Florida, 34695

  • GSK Investigational Site

    Saint Cloud, Minnesota, 56303

  • GSK Investigational Site

    Saint Paul, Minnesota, 55101

  • GSK Investigational Site

    Salisbury, Maryland, 21801

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92161

  • GSK Investigational Site

    San Marcos, Texas, 78666

  • GSK Investigational Site

    Sandusky, Ohio, 44870

  • GSK Investigational Site

    Sanford, North Carolina, 27330

  • GSK Investigational Site

    Santa Ana, California, 92704

  • GSK Investigational Site

    Santa Ana, California, 92705

  • GSK Investigational Site

    Sarasota, Florida, 34232

  • GSK Investigational Site

    Sayre, Pennsylvania, 18840

  • GSK Investigational Site

    Scarborough, Maine, 04074

  • GSK Investigational Site

    Scranton, Pennsylvania, 18501

  • GSK Investigational Site

    Sellersville, Pennsylvania, 18960

  • GSK Investigational Site

    Sewell, New Jersey, 08080

  • GSK Investigational Site

    Shreveport, Louisiana, 71105

  • GSK Investigational Site

    Somerset, New Jersey, 08873

  • GSK Investigational Site

    South Bend, Indiana, 46601-1066

  • GSK Investigational Site

    Spokane, Washington, 99204-2334

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    Springfield, Massachusetts, 01199

  • GSK Investigational Site

    Springfield, Missouri, 65804

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    St Louis, Missouri, 63128

  • GSK Investigational Site

    St. Petersburg, Florida, 33713

  • GSK Investigational Site

    Stockton, California, 95204

  • GSK Investigational Site

    Stony Brook, New York, 11794

  • GSK Investigational Site

    Sugar Land, Texas, 77479

  • GSK Investigational Site

    Summit, New Jersey, 07902

  • GSK Investigational Site

    Syracuse, New York, 13202

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    The Bronx, New York, 10467

  • GSK Investigational Site

    Thousand Oaks, California, 91360

  • GSK Investigational Site

    Toledo, Ohio, 43606

  • GSK Investigational Site

    Toledo, Ohio, 43614

  • GSK Investigational Site

    Torrance, California, 90509

  • GSK Investigational Site

    Towson, Maryland, 21204

  • GSK Investigational Site

    Trinity, Florida, 34655

  • GSK Investigational Site

    Troy, Michigan, 48085

  • GSK Investigational Site

    Troy, New York, 12180

  • GSK Investigational Site

    Tucson, Arizona, 85710

  • GSK Investigational Site

    Tucson, Arizona, 85723

  • GSK Investigational Site

    Tucson, Arizona, 85724

  • GSK Investigational Site

    Tupelo, Mississippi, 38801

  • GSK Investigational Site

    Tyler, Texas, 75708

  • GSK Investigational Site

    Valparaiso, Indiana, 46383

  • GSK Investigational Site

    Ventura, California, 93003

  • GSK Investigational Site

    Vero Beach, Florida, 32960

  • GSK Investigational Site

    Victoria, Texas, 77901

  • GSK Investigational Site

    Voorhees Township, New Jersey, 08043

  • GSK Investigational Site

    Walla Walla, Washington, 99362

  • GSK Investigational Site

    Wausau, Wisconsin, 54401

  • GSK Investigational Site

    Wellington, Florida, 33449

  • GSK Investigational Site

    West Chester, Pennsylvania, 19380

  • GSK Investigational Site

    West Des Moines, Iowa, 50266

  • GSK Investigational Site

    West Orange, New Jersey, 07052

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

  • GSK Investigational Site

    Williamsville, New York, 14221

  • GSK Investigational Site

    Winchester, Virginia, 22601

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27157

  • GSK Investigational Site

    Worcester, Massachusetts, 01655

  • GSK Investigational Site

    York, Pennsylvania, 17405

  • GSK Investigational Site

    Youngstown, Ohio, 44501-1790

  • GSK Investigational Site

    Ypsilanti, Michigan, 48197

  • GSK Investigational Site

    Zanesville, Ohio, 43701

Other trials in United States

Russia40 sites

  • GSK Investigational Site

    Barnaul, 656024

  • GSK Investigational Site

    Gatchina, 188300

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Kemerovo, 650036

  • GSK Investigational Site

    Krasnoyarsk, 660097

  • GSK Investigational Site

    Moscow, 105187

  • GSK Investigational Site

    Moscow, 111020

  • GSK Investigational Site

    Moscow, 111539

  • GSK Investigational Site

    Moscow, 117292

  • GSK Investigational Site

    Moscow, 119620

  • GSK Investigational Site

    Moscow, 119991

  • GSK Investigational Site

    Moscow, 121 309

  • GSK Investigational Site

    Moscow, 121552

  • GSK Investigational Site

    Moscow, 127018

  • GSK Investigational Site

    Moscow, 127473

  • GSK Investigational Site

    Nizhny Novgorod, 603035

  • GSK Investigational Site

    Nizhny Novgorod, 603076

  • GSK Investigational Site

    Novosibirsk, 630008

  • GSK Investigational Site

    Novosibirsk, 630047

  • GSK Investigational Site

    Orenburg, 460040

  • GSK Investigational Site

    Saint Petersburg, 190000

  • GSK Investigational Site

    Saint Petersburg, 192242

  • GSK Investigational Site

    Saint Petersburg, 193079

  • GSK Investigational Site

    Saint Petersburg, 193312

  • GSK Investigational Site

    Saint Petersburg, 195067

  • GSK Investigational Site

    Saint Petersburg, 196247

  • GSK Investigational Site

    Saint Petersburg, 196601

  • GSK Investigational Site

    Saint Petersburg, 198013

  • GSK Investigational Site

    Saint Petersburg, 198205

  • GSK Investigational Site

    Saint Petersburg, 199106

  • GSK Investigational Site

    Samara, 443070

  • GSK Investigational Site

    Saratov, 410028

  • GSK Investigational Site

    Saratov, 410054

  • GSK Investigational Site

    St'Petersburg, 194156

  • GSK Investigational Site

    Tomsk, 643012

  • GSK Investigational Site

    Tyumen, 625023

  • GSK Investigational Site

    Tyumen, 625026

  • GSK Investigational Site

    Yaroslavl, 150003

  • GSK Investigational Site

    Yekaterinburg, 620039

  • GSK Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

Netherlands36 sites

  • GSK Investigational Site

    's-Hertogenbosch, 5223 GZ

  • GSK Investigational Site

    Amersfoort, 3818 ES

  • GSK Investigational Site

    Amsterdam, 1061 AE

  • GSK Investigational Site

    Amsterdam, 1091 AC

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Apeldoorn, 7334 DZ

  • GSK Investigational Site

    Blaricum, 1261 AN

  • GSK Investigational Site

    Deventer, 7416 SE

  • GSK Investigational Site

    Dirksland, 3247 BW

  • GSK Investigational Site

    Doetinchem, 7009 BL

  • GSK Investigational Site

    Drachten, 9202 NN

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Gorinchem, 4204 AA

  • GSK Investigational Site

    Gouda, 2803 HH

  • GSK Investigational Site

    Groningen, 9728 NT

  • GSK Investigational Site

    Hardenberg, 7772 SE

  • GSK Investigational Site

    Harderwijk, 3844 DG

  • GSK Investigational Site

    Heerenveen, 8441 PW

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Helmond, 5707 HA

  • GSK Investigational Site

    Hilversum, 1213 XZ

  • GSK Investigational Site

    Hoofddorp, 2134 TM

  • GSK Investigational Site

    Hoorn, 1625 HV

  • GSK Investigational Site

    Nijmegen, 6532 SZ

  • GSK Investigational Site

    Oss, 5342 BT

  • GSK Investigational Site

    Roermond, 6043 CV

  • GSK Investigational Site

    Rotterdam, 3045 PM

  • GSK Investigational Site

    Rotterdam, 3083 AN

  • GSK Investigational Site

    Sittard-geleen, 6162 BG

  • GSK Investigational Site

    Sneek, 8601 ZR

  • GSK Investigational Site

    The Hague, 2597 AX

  • GSK Investigational Site

    Tiel, 4002 WP

  • GSK Investigational Site

    Tilburg, 5042AD

  • GSK Investigational Site

    Veldhoven, 5504 DB

  • GSK Investigational Site

    Venlo, 5912 BL

  • GSK Investigational Site

    Zoetermeer, 2725 NA

Other trials in Netherlands

Germany33 sites

  • GSK Investigational Site

    Altenburg, Thuringia, 04600

  • GSK Investigational Site

    Bad Krozingen, Baden-Wurttemberg, 79189

  • GSK Investigational Site

    Bad Nauheim, Hesse, 61231

  • GSK Investigational Site

    Bad Rothenfelde, Lower Saxony, 49214

  • GSK Investigational Site

    Berlin, 12351

  • GSK Investigational Site

    Berlin, 12559

  • GSK Investigational Site

    Berlin, 13353

  • GSK Investigational Site

    Bielefeld, North Rhine-Westphalia, 33604

  • GSK Investigational Site

    Bremen, 28277

  • GSK Investigational Site

    Darmstadt, Hesse, 64283

  • GSK Investigational Site

    Eschweiler, North Rhine-Westphalia, 52249

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60590

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 65929

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Halle, 06120

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • GSK Investigational Site

    Homburg, Saarland, 66421

  • GSK Investigational Site

    Kiel, Schleswig-Holstein, 24105

  • GSK Investigational Site

    Langen, Hesse, 63225

  • GSK Investigational Site

    Limburg an der Lahn, Hesse, 65549

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23538

  • GSK Investigational Site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • GSK Investigational Site

    Munich, Bavaria, 80336

  • GSK Investigational Site

    Munich, Bavaria, 81737

  • GSK Investigational Site

    Neuss, North Rhine-Westphalia, 41464

  • GSK Investigational Site

    Oldenburg, Lower Saxony, 26133

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70376

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89081

  • GSK Investigational Site

    Wuppertal, North Rhine-Westphalia, 42117

Other trials in Germany

Poland32 sites

  • GSK Investigational Site

    Bialystok, 15-276

  • GSK Investigational Site

    Bydgoszcz, 85-079

  • GSK Investigational Site

    Bytom, 41-902

  • GSK Investigational Site

    Chrzanów, 32-500

  • GSK Investigational Site

    Gdansk, 80-952

  • GSK Investigational Site

    Gdynia, 81-423

  • GSK Investigational Site

    Gdynia, 81-472

  • GSK Investigational Site

    Gdynia, 81-519

  • GSK Investigational Site

    Inowrocław

  • GSK Investigational Site

    Krakow, 31-121

  • GSK Investigational Site

    Krakow, 31-202

  • GSK Investigational Site

    Lodz, 91-347

  • GSK Investigational Site

    Lubin, 59-300

  • GSK Investigational Site

    Mielec, 39-300

  • GSK Investigational Site

    Oława, 55-200

  • GSK Investigational Site

    Opole, 45-418

  • GSK Investigational Site

    Radom, 26-617

  • GSK Investigational Site

    Skierniewice, 96-100

  • GSK Investigational Site

    Tarnów, 33-100

  • GSK Investigational Site

    Torun, 87-100

  • GSK Investigational Site

    Tychy, 43-100

  • GSK Investigational Site

    Wałbrzych, 58-309

  • GSK Investigational Site

    Warsaw, 00-685

  • GSK Investigational Site

    Warsaw, 02-507

  • GSK Investigational Site

    Warsaw, 02-637

  • GSK Investigational Site

    Warsaw, 04-073

  • GSK Investigational Site

    Włocławek, 87-800

  • GSK Investigational Site

    Wroclaw, 50-349

  • GSK Investigational Site

    Wroclaw, 50-367

  • GSK Investigational Site

    Wroclaw, 51-124

  • GSK Investigational Site

    Zamość, 22-400

  • GSK Investigational Site

    Zielona Góra, 65-046

Other trials in Poland

Brazil31 sites

  • GSK Investigational Site

    Bahia, 40050-410

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30130-110

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30150-221.

  • GSK Investigational Site

    Brasília, 70658-700

  • GSK Investigational Site

    Campina Grande do Sul, Paraná, 83430000

  • GSK Investigational Site

    Campinas, 13060-803

  • GSK Investigational Site

    Campo Grande, 79080-090

  • GSK Investigational Site

    Curitiba, Paraná, 80730-150

  • GSK Investigational Site

    Fortaleza, Ceará, 60864-190

  • GSK Investigational Site

    Goiânia - GO, Goiás, 74605-020

  • GSK Investigational Site

    Marília, São Paulo, 17515-000

  • GSK Investigational Site

    Natal, Rio Grande do Norte, 59020-100

  • GSK Investigational Site

    Pelotas, Rio Grande do Sul, 96015-290

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90610000

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90620001

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90880-480

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 91350-200

  • GSK Investigational Site

    Rio de Janeiro, 21041-030

  • GSK Investigational Site

    Rio de Janeiro, RJ 22240-000

  • GSK Investigational Site

    Salvador, Estado de Bahia, 41810010

  • GSK Investigational Site

    São José do Rio Preto, São Paulo, 15015210

  • GSK Investigational Site

    São José do Rio Preto, São Paulo, 15090-000

  • GSK Investigational Site

    São Paulo, São Paulo, 04024-900

  • GSK Investigational Site

    São Paulo, 04012-180

  • GSK Investigational Site

    São Paulo, 05403000

  • GSK Investigational Site

    São Paulo, 05508-900

  • GSK Investigational Site

    São Paulo - SP, 01323-900

  • GSK Investigational Site

    Uberlândia, 38400-902

  • GSK Investigational Site

    Votuporanga, São Paulo, 15500-003

Other trials in Brazil

Canada31 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 7K8

  • GSK Investigational Site

    Brampton, Ontario, L6Z 4N5

  • GSK Investigational Site

    Cambridge, Ontario, N1R 6V6

  • GSK Investigational Site

    Cambridge, Ontario, N1R 7R1

  • GSK Investigational Site

    Campbell River, British Columbia, V9W 5Y4

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2B7

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3C 1S8

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 3B8

  • GSK Investigational Site

    Greenfield Park, Quebec, JAV 2GB

  • GSK Investigational Site

    Hamilton, Ontario, L8L 2X2

  • GSK Investigational Site

    Kelowna, Ontario, V1Y 1E4

  • GSK Investigational Site

    Longueuil, Quebec, J4M 2X1

  • GSK Investigational Site

    Mississauga, Ontario, L5B 2P7

  • GSK Investigational Site

    Montreal, Quebec, H1T 3Y7

  • GSK Investigational Site

    Montreal, Quebec, H3G 1A4

  • GSK Investigational Site

    New Westminster, British Columbia, V3L 3W4

  • GSK Investigational Site

    Newmarket, Ontario, L3Y 8C3

  • GSK Investigational Site

    Oshawa, Ontario, L1J 2J9

  • GSK Investigational Site

    Oshawa, Ontario, L1J 2K1

  • GSK Investigational Site

    Ottawa, Ontario, K1Y 4W7

  • GSK Investigational Site

    Sarnia, Ontario, N7T 4X3

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • GSK Investigational Site

    Surrey, British Columbia, V3V 1N1

  • GSK Investigational Site

    Thetford-Mines, Quebec, G6G 2V4

  • GSK Investigational Site

    Thunder Bay, Ontario, P7B 7C7

  • GSK Investigational Site

    Toronto, Ontario, M4C 3E7

  • GSK Investigational Site

    Toronto, Ontario, M5C 2T2

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • GSK Investigational Site

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

India27 sites

  • GSK Investigational Site

    Ahmedabad, 380052

  • GSK Investigational Site

    Ahmedabad, 380060

  • GSK Investigational Site

    Amritsar, 143004

  • GSK Investigational Site

    Chennai, 600037

  • GSK Investigational Site

    Chennai, 600081

  • GSK Investigational Site

    Faridabad, 121001

  • GSK Investigational Site

    Gandhinagar, 382428

  • GSK Investigational Site

    Gūrgaon, 122001

  • GSK Investigational Site

    Hyderabad, 500001

  • GSK Investigational Site

    Hyderabad, 500020

  • GSK Investigational Site

    Hyderabad, 500033

  • GSK Investigational Site

    Hyderabad, 500063

  • GSK Investigational Site

    Hyderabad, 500082

  • GSK Investigational Site

    Indore, 452018

  • GSK Investigational Site

    Jaipur, 302017

  • GSK Investigational Site

    Lucknow, 226014

  • GSK Investigational Site

    Mohali, 160062

  • GSK Investigational Site

    New Delhi, 110025

  • GSK Investigational Site

    New Delhi, 110060

  • GSK Investigational Site

    New Delhi, 110070

  • GSK Investigational Site

    Noida, 201301

  • GSK Investigational Site

    Patiāla, 147001

  • GSK Investigational Site

    Pune, 411001

  • GSK Investigational Site

    Pune, 411004

  • GSK Investigational Site

    Secunderabad, 500003

  • GSK Investigational Site

    Vadodara, 390015

  • GSK Investigational Site

    Visakhapatnam, 530002

Other trials in India

China26 sites

  • GSK Investigational Site

    Beijing, 100020

  • GSK Investigational Site

    Beijing, 100029

  • GSK Investigational Site

    Beijing, 100037

  • GSK Investigational Site

    Beijing, 100050

  • GSK Investigational Site

    Beijing, 100730

  • GSK Investigational Site

    Beijing, 100853

  • GSK Investigational Site

    Chengdu, Sichuan, 610041

  • GSK Investigational Site

    Dalian, Liaoning, 116027

  • GSK Investigational Site

    Guangzhou, Guangdong, 510080

  • GSK Investigational Site

    Guangzhou, Guangdong, 510120

  • GSK Investigational Site

    Haikou, Hainan, 570102

  • GSK Investigational Site

    Hangzhou, Zhejiang, 310009

  • GSK Investigational Site

    Hangzhou, 310016

  • GSK Investigational Site

    Jinan, Shandong, 250033

  • GSK Investigational Site

    Jinan, 250012

  • GSK Investigational Site

    Lanzhou, Gansu, 730030

  • GSK Investigational Site

    Nanjing, Jiangsu, 210029

  • GSK Investigational Site

    Nanning, Guangxi, 530021

  • GSK Investigational Site

    Shanghai, 200003

  • GSK Investigational Site

    Shanghai, 200040

  • GSK Investigational Site

    Shanghai, 200065

  • GSK Investigational Site

    Shenyang, Liaoning, 110004

  • GSK Investigational Site

    Shenyang, Liaoning, 110016

  • GSK Investigational Site

    Shijiazhuang, Hebei, 050000

  • GSK Investigational Site

    Suzhou, 215004

  • GSK Investigational Site

    Xi'an, Shaanxi, 710061

Other trials in China

Argentina25 sites

  • GSK Investigational Site

    Buenos Aires, 1425

  • GSK Investigational Site

    Buenos Aires, C1181ACH

  • GSK Investigational Site

    Capital Federal, Buenos Aires, C1180AAX

  • GSK Investigational Site

    Cipolletti, R8324CVM

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1179AAB

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AST

  • GSK Investigational Site

    Córdoba, Córdoba Province, X5000AAW

  • GSK Investigational Site

    Córdoba, Córdoba Province, X5000EPU

  • GSK Investigational Site

    Corrientes, W3400AMZ

  • GSK Investigational Site

    Haedo, Buenos Aires, B1706AJU

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, B7600FZN

  • GSK Investigational Site

    Ramos Mejía, Buenos Aires, B1704ETD

  • GSK Investigational Site

    Rosario, Santa Fe Province, 2002

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000BIF

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000CVD

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000ODA

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2002OUR

  • GSK Investigational Site

    San Justo, Buenos Aires, B1754FPI

  • GSK Investigational Site

    San Miguel de Tucumán, T4000ICL

  • GSK Investigational Site

    San Miguel de Tucumán, T4000IFL

  • GSK Investigational Site

    San Nicolás de los Arroyos, Buenos Aires, B2900DMH

  • GSK Investigational Site

    Santa Fe, 3000

  • GSK Investigational Site

    Sante Fe, S3000FSO

  • GSK Investigational Site

    Sante Fe, S3000GCI

  • GSK Investigational Site

    Zárate, B2800DGH

Other trials in Argentina

Japan24 sites

  • GSK Investigational Site

    Chiba, 270-2251

  • GSK Investigational Site

    Fukuoka, 807-0051

  • GSK Investigational Site

    Fukuoka, 811-0213

  • GSK Investigational Site

    Fukuoka, 816-0864

  • GSK Investigational Site

    Hokkaido, 006-8555

  • GSK Investigational Site

    Hokkaido, 063-0005

  • GSK Investigational Site

    Hokkaido, 065-0033

  • GSK Investigational Site

    Hyōgo, 650-0047

  • GSK Investigational Site

    Kanagawa, 232-0024

  • GSK Investigational Site

    Kanagawa, 243-8551

  • GSK Investigational Site

    Kanagawa, 247-8533

  • GSK Investigational Site

    Kyoto, 606-8507

  • GSK Investigational Site

    Nagasaki, 856-8562

  • GSK Investigational Site

    Ōita, 870-0263

  • GSK Investigational Site

    Okayama, 700-8558

  • GSK Investigational Site

    Osaka, 565-8565

  • GSK Investigational Site

    Osaka, 574-0074

  • GSK Investigational Site

    Osaka, 580-0032

  • GSK Investigational Site

    Saga, 843-0393

  • GSK Investigational Site

    Shizuoka, 410-2295

  • GSK Investigational Site

    Tokyo, 101-8643

  • GSK Investigational Site

    Tokyo, 113-8431

  • GSK Investigational Site

    Tokyo, 160-8582

  • GSK Investigational Site

    Tokyo, 196-0003

Other trials in Japan

France22 sites

  • GSK Investigational Site

    Avignon, 84000

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Bron, 69677

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Dijon, 21079

  • GSK Investigational Site

    Dunkirk, Hauts-de-France, 59240

  • GSK Investigational Site

    Lagny-sur-Marne, 77405

  • GSK Investigational Site

    Langres, Champagne-Ardenne, 52206

  • GSK Investigational Site

    Le Plessis-Robinson, 92350

  • GSK Investigational Site

    Lille, 59000

  • GSK Investigational Site

    Marseille, 13285

  • GSK Investigational Site

    Montfermeil, 93370

  • GSK Investigational Site

    Paris, 75651

  • GSK Investigational Site

    Paris, 75877

  • GSK Investigational Site

    Pau, Aquitaine, 64046

  • GSK Investigational Site

    Poitiers, 86021

  • GSK Investigational Site

    Quincy-sous-Sénart, 91480

  • GSK Investigational Site

    Rennes, 35033

  • GSK Investigational Site

    Strasbourg, 67091

  • GSK Investigational Site

    Toulouse, 31500

  • GSK Investigational Site

    Tourcoing, 59200

  • GSK Investigational Site

    Valenciennes, 59300

Other trials in France

Italy22 sites

  • GSK Investigational Site

    Ascoli Piceno, The Marches, 63100

  • GSK Investigational Site

    Bergamo, Lombardy, 24128

  • GSK Investigational Site

    Bologna, Emilia-Romagna, 40138

  • GSK Investigational Site

    Carpi, Emilia-Romagna, 41012

  • GSK Investigational Site

    Catanzaro, Calabria, 88100

  • GSK Investigational Site

    Ferrara, Emilia-Romagna, 44100

  • GSK Investigational Site

    Legnano, 20025

  • GSK Investigational Site

    Milan, Lombardy, 20162

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Novara, Piedmont, 28100

  • GSK Investigational Site

    Palmanova, Friuli Venezia Giulia, 33057

  • GSK Investigational Site

    Parma, Emilia-Romagna, 43100

  • GSK Investigational Site

    Pisa, Tuscany, 56126

  • GSK Investigational Site

    Rome, Lazio, 00135

  • GSK Investigational Site

    Rome, Lazio, 00168

  • GSK Investigational Site

    Rome, Lazio, 00189

  • GSK Investigational Site

    Rozzano (Mi), Lombardy, 20089

  • GSK Investigational Site

    San Daniele del Friuli, Friuli Venezia Giulia, 33038

  • GSK Investigational Site

    Sassari, Sardinia, 07100

  • GSK Investigational Site

    Sassuolo, 41049

  • GSK Investigational Site

    Treviso, Veneto, 31100

  • GSK Investigational Site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Ukraine20 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49006

  • GSK Investigational Site

    Donetsk, 83114

  • GSK Investigational Site

    Kharkiv, 61002

  • GSK Investigational Site

    Kharkiv, 61018

  • GSK Investigational Site

    Kharkiv, 61039

  • GSK Investigational Site

    Kharkiv, 61176

  • GSK Investigational Site

    Kyiv, 01601

  • GSK Investigational Site

    Kyiv, 02091

  • GSK Investigational Site

    Kyiv, 02660

  • GSK Investigational Site

    Kyiv, 03049

  • GSK Investigational Site

    Kyiv, 03680

  • GSK Investigational Site

    Kyiv, 3115

  • GSK Investigational Site

    Luhansk, 91045

  • GSK Investigational Site

    Lutsk, 43024

  • GSK Investigational Site

    Mykolaiv, 54033

  • GSK Investigational Site

    Odesa, 65014

  • GSK Investigational Site

    Simferopol, 95026

  • GSK Investigational Site

    Vinnytsia, 21018

  • GSK Investigational Site

    Vinnytsia, 21029

  • GSK Investigational Site

    Zaporizhzhya, 69000

Other trials in Ukraine

Denmark19 sites

  • GSK Investigational Site

    Aalborg, DK-9000

  • GSK Investigational Site

    Aarhus, DK-8000

  • GSK Investigational Site

    Esbjerg, 6700

  • GSK Investigational Site

    Frederikssund, DK-3600

  • GSK Investigational Site

    Glostrup Municipality, DK-2600

  • GSK Investigational Site

    Hellerup, 2900

  • GSK Investigational Site

    Herlev, DK-2730

  • GSK Investigational Site

    Holbæk, DK-4300

  • GSK Investigational Site

    Hvidovre, DK-2650

  • GSK Investigational Site

    København NV, DK-2400

  • GSK Investigational Site

    København S, DK-2300

  • GSK Investigational Site

    Koebenhavn N, 2100

  • GSK Investigational Site

    Køge, DK-4600

  • GSK Investigational Site

    Kolding, DK-6000

  • GSK Investigational Site

    Næstved, 4700

  • GSK Investigational Site

    Odense C, DK-5000

  • GSK Investigational Site

    Roskilde, 4000

  • GSK Investigational Site

    Silkeborg, DK-8600

  • GSK Investigational Site

    Svendborg, 5700

Other trials in Denmark

Israel19 sites

  • GSK Investigational Site

    Ashkelon, 78278

  • GSK Investigational Site

    Beersheba, 84350

  • GSK Investigational Site

    Haddera, 38100

  • GSK Investigational Site

    Haifa, 31048

  • GSK Investigational Site

    Haifa, 31096

  • GSK Investigational Site

    Haifa, 34362

  • GSK Investigational Site

    Holon, 58100

  • GSK Investigational Site

    Jerusalem, 91004

  • GSK Investigational Site

    Jerusalem, 91031

  • GSK Investigational Site

    Jerusalem, 91120

  • GSK Investigational Site

    Jerusalem, 91240

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Nahariya, 22100

  • GSK Investigational Site

    Poria – Neve Oved, 15208

  • GSK Investigational Site

    Raanana, 43000

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Rehovot, 76100

  • GSK Investigational Site

    Safed, 13110

  • GSK Investigational Site

    Tel Aviv, 64239

Other trials in Israel

South Africa19 sites

  • GSK Investigational Site

    Alberton, Gauteng, 1449

  • GSK Investigational Site

    Bloemfontein, Free State, 9301

  • GSK Investigational Site

    Cape Town, Western Province, 7500

  • GSK Investigational Site

    Cape Town, Western Province, 7530

  • GSK Investigational Site

    Durban, KwaZulu-Natal, 4001

  • GSK Investigational Site

    Durban, KwaZulu-Natal, 4052

  • GSK Investigational Site

    Goodwood, 7460

  • GSK Investigational Site

    Johannesburg, Gauteng, 2000

  • GSK Investigational Site

    Kempton Park, 1619

  • GSK Investigational Site

    Paarl, 7646

  • GSK Investigational Site

    Panorama, Western Province, 7500

  • GSK Investigational Site

    Parktown West, 2193

  • GSK Investigational Site

    Parow, 7505

  • GSK Investigational Site

    Pretoria, Gauteng, 0001

  • GSK Investigational Site

    Pretoria, Gauteng, 0132

  • GSK Investigational Site

    Pretoria, 0002

  • GSK Investigational Site

    Pretoria, 0041

  • GSK Investigational Site

    Somerset West, 7130

  • GSK Investigational Site

    Worcester, 6850

Other trials in South Africa

Hungary17 sites

  • GSK Investigational Site

    Budapest, 1032

  • GSK Investigational Site

    Budapest, 1096

  • GSK Investigational Site

    Budapest, 1106

  • GSK Investigational Site

    Budapest, 1122

  • GSK Investigational Site

    Budapest, 1125

  • GSK Investigational Site

    Budapest, 1134

  • GSK Investigational Site

    Budapest, 1145

  • GSK Investigational Site

    Cegléd, 2700

  • GSK Investigational Site

    Eger, 3300

  • GSK Investigational Site

    Gyula, 5700

  • GSK Investigational Site

    Hódmezővásárhely, 6800

  • GSK Investigational Site

    Kistarcsa, 2143

  • GSK Investigational Site

    Miskolc, 3526

  • GSK Investigational Site

    Székesfehérvár, 8000

  • GSK Investigational Site

    Szolnok, 5004

  • GSK Investigational Site

    Szombathely, 9700

  • GSK Investigational Site

    Zalaegerszeg, 8900

Other trials in Hungary

United Kingdom15 sites

  • GSK Investigational Site

    Airdrie, Lanarkshire, ML6 0JS

  • GSK Investigational Site

    Antrim, BT41 2RL

  • GSK Investigational Site

    Chertsey, Surrey, KT16 0PZ

  • GSK Investigational Site

    Chichester, PO19 6SE

  • GSK Investigational Site

    Coventry, West Midlands, CV2 2DX

  • GSK Investigational Site

    East Kilbride, G75 8RG

  • GSK Investigational Site

    Exeter, Devon, EX2 5DW

  • GSK Investigational Site

    Harrow, Middlesex, HA1 3UJ

  • GSK Investigational Site

    Hertfordshire

  • GSK Investigational Site

    Liverpool, L7 8XP

  • GSK Investigational Site

    Northampton, Northamptonshire, NN1 5BD

  • GSK Investigational Site

    Nottingham, Nottinghamshire, NG5 1PB

  • GSK Investigational Site

    Paisley, PA2 9PN

  • GSK Investigational Site

    Stirling, FK8 2AU

  • GSK Investigational Site

    Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Czechia14 sites

  • GSK Investigational Site

    Brno, 625 00

  • GSK Investigational Site

    Brno, 656 91

  • GSK Investigational Site

    Čáslav, 286 01

  • GSK Investigational Site

    Jihlava, 586 33

  • GSK Investigational Site

    Kroměříž, 767 55

  • GSK Investigational Site

    Milevsko, 399 01

  • GSK Investigational Site

    Olomouc, 775 20

  • GSK Investigational Site

    Plzen - Bory, 305 99

  • GSK Investigational Site

    Prague, 100 34

  • GSK Investigational Site

    Prague, 128 08

  • GSK Investigational Site

    Slaný

  • GSK Investigational Site

    Svitavy, 568 25

  • GSK Investigational Site

    Ústí nad Orlicí, 562 18

  • GSK Investigational Site

    Zlín, 762 75

Other trials in Czechia

Romania14 sites

  • GSK Investigational Site

    Baia Mare, 430123

  • GSK Investigational Site

    Brăila, 810249

  • GSK Investigational Site

    Brasov, 500326

  • GSK Investigational Site

    Bucharest, 011461

  • GSK Investigational Site

    Bucharest, 011794

  • GSK Investigational Site

    Bucharest, 014461

  • GSK Investigational Site

    Bucharest, 022328

  • GSK Investigational Site

    Bucharest, 041915

  • GSK Investigational Site

    Bucharest, 050098

  • GSK Investigational Site

    Cluj-Napoca, 400001

  • GSK Investigational Site

    Constanța, 900591

  • GSK Investigational Site

    Craiova, 200642

  • GSK Investigational Site

    Iași, 700503

  • GSK Investigational Site

    Târgu Mureş, 540136

Other trials in Romania

Spain14 sites

  • GSK Investigational Site

    Alicante, 03010

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    León, 24071

  • GSK Investigational Site

    Lleida, 25198

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Oviedo, 33006

  • GSK Investigational Site

    San Juan/Alicante, 03550

  • GSK Investigational Site

    San Sebastián, 20014

  • GSK Investigational Site

    San Sebastián de Los Reyes/Madrid

  • GSK Investigational Site

    Seville, 41009

  • GSK Investigational Site

    Valencia, 46014

  • GSK Investigational Site

    Vigo/Pontevedra, 36200

Other trials in Spain

Australia13 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Ashford, 5035

  • GSK Investigational Site

    Auchenflower, Queensland, 4066

  • GSK Investigational Site

    Box Hill, Victoria, 3128

  • GSK Investigational Site

    Camperdown, New South Wales, 2050

  • GSK Investigational Site

    Elizabeth Vale, South Australia, 5112

  • GSK Investigational Site

    Fremantle, Western Australia, 6160

  • GSK Investigational Site

    Garran, Australian Capital Territory, 2606

  • GSK Investigational Site

    Gosford, New South Wales, 2250

  • GSK Investigational Site

    Herston, Queensland, 4029

  • GSK Investigational Site

    Hobart, Tasmania, 7000

  • GSK Investigational Site

    Milton, Queensland, 4064

  • GSK Investigational Site

    Nedlands, Victoria, 6009

Other trials in Australia

Bulgaria12 sites

  • GSK Investigational Site

    Dimitrovgrad, 6400

  • GSK Investigational Site

    Haskovo, 6300

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Plovdiv, 4002

  • GSK Investigational Site

    Plovdiv, 4003

  • GSK Investigational Site

    Sofia, 1000

  • GSK Investigational Site

    Sofia, 1202

  • GSK Investigational Site

    Sofia, 1407

  • GSK Investigational Site

    Sofia, 1527

  • GSK Investigational Site

    Sofia, 1606

  • GSK Investigational Site

    Sofia, 1709

  • GSK Investigational Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Belgium11 sites

  • GSK Investigational Site

    Aalst, 9300

  • GSK Investigational Site

    Bonheiden, 2820

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Brussels, 1090

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Genk, 3600

  • GSK Investigational Site

    La Louvière, 7100

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

  • GSK Investigational Site

    Roeselaere, 8800

Other trials in Belgium

New Zealand11 sites

  • GSK Investigational Site

    Auckland, 2025

  • GSK Investigational Site

    Auckland

  • GSK Investigational Site

    Christchurch

  • GSK Investigational Site

    Dunedin

  • GSK Investigational Site

    Hamilton, 3204

  • GSK Investigational Site

    Lower Hutt, 6007

  • GSK Investigational Site

    New Plymouth, 4310

  • GSK Investigational Site

    Palmerston North

  • GSK Investigational Site

    Takapuna, Auckland, 0622

  • GSK Investigational Site

    Tauranga

  • GSK Investigational Site

    Whangarei

Other trials in New Zealand

Chile10 sites

  • GSK Investigational Site

    Concepción, Región Del Biobio, 56-41

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 750 0922

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7650018

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8330024

  • GSK Investigational Site

    Santiago, 8207257

  • GSK Investigational Site

    Santiago, 8900085

  • GSK Investigational Site

    Talcahuano, Región Del Biobio, 427 0918

  • GSK Investigational Site

    Temuco, Región de La Araucania

  • GSK Investigational Site

    Temuco

  • GSK Investigational Site

    Viña del Mar, Valparaiso

Other trials in Chile

South Korea10 sites

  • GSK Investigational Site

    Daegu, 700-721

  • GSK Investigational Site

    Daejeon, 301721

  • GSK Investigational Site

    Gangnam-gu, Seoul, 135-710

  • GSK Investigational Site

    Gwangju, 501-757

  • GSK Investigational Site

    Kangwon-do, 220-701

  • GSK Investigational Site

    Pusan, 602-739

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Seoul, 138-736

Other trials in South Korea

Colombia9 sites

  • GSK Investigational Site

    Armenia

  • GSK Investigational Site

    Barranquilla

  • GSK Investigational Site

    Bogotá, 38007

  • GSK Investigational Site

    Bogotá, 5600520

  • GSK Investigational Site

    Bogotá

  • GSK Investigational Site

    Bucaramanga

  • GSK Investigational Site

    Cartagena

  • GSK Investigational Site

    Manizales

  • GSK Investigational Site

    Medellín

Other trials in Colombia

Sweden9 sites

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Gothenburg, SE-41685

  • GSK Investigational Site

    Gothenburg, SE-43180

  • GSK Investigational Site

    Hässleholm, SE-28125

  • GSK Investigational Site

    Jönköping, SE-551 85

  • GSK Investigational Site

    Örebro, SE-70185

  • GSK Investigational Site

    Östersund, SE-831 83

  • GSK Investigational Site

    Stockholm, SE-11883

  • GSK Investigational Site

    Västerås, SE-721 89

Other trials in Sweden

Slovakia8 sites

  • GSK Investigational Site

    Bratislava, 813 69

  • GSK Investigational Site

    Bratislava, 826 06

  • GSK Investigational Site

    Bratislava, 833 05

  • GSK Investigational Site

    Bratislava, 833 48

  • GSK Investigational Site

    Košice, 040 22

  • GSK Investigational Site

    Nitra, 949 01

  • GSK Investigational Site

    Nitra, 950 01

  • GSK Investigational Site

    Nové Zámky, 940 52

Other trials in Slovakia

Peru7 sites

  • GSK Investigational Site

    Callao, Callao 02

  • GSK Investigational Site

    Lima, Lima 11

  • GSK Investigational Site

    Lima, Lima 27

  • GSK Investigational Site

    Lima, Lima 33

  • GSK Investigational Site

    Lima Cercado, LIMA 01

  • GSK Investigational Site

    Miraflores, Lima, Lima, Lima 18

  • GSK Investigational Site

    San Martín de Porres, Lima region, Lima 31

Other trials in Peru

Philippines6 sites

  • GSK Investigational Site

    Cebu City, 6000

  • GSK Investigational Site

    Davao City, 8000

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Quezon City, 1100

  • GSK Investigational Site

    Quezon City, 1109

  • GSK Investigational Site

    Quezon City, 1113

Other trials in Philippines

Taiwan6 sites

  • GSK Investigational Site

    Kaohsiung City, 807

  • GSK Investigational Site

    Kaohsiung City, 833

  • GSK Investigational Site

    Taipei, 111

  • GSK Investigational Site

    Taipei, 112

  • GSK Investigational Site

    Taipei, 220

  • GSK Investigational Site

    Yung Kang City, 71044

Other trials in Taiwan

Thailand6 sites

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Bangkoknoi, 10700

  • GSK Investigational Site

    Chiang Mai, 50200

  • GSK Investigational Site

    Khon Kaen, Muang, 40002

  • GSK Investigational Site

    Nakhon Ratchasima, 30000

  • GSK Investigational Site

    Pathum Thani, 12120

Other trials in Thailand

Turkey (Türkiye)6 sites

  • GSK Investigational Site

    Ankara, 06500

  • GSK Investigational Site

    Erzurum, 25240

  • GSK Investigational Site

    Eskişehir, 26480

  • GSK Investigational Site

    Izmir, 35100

  • GSK Investigational Site

    Izmir, 35340

  • GSK Investigational Site

    Izmir, 35360

Other trials in Turkey (Türkiye)

About this study

Official title: A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g. medical procedures performed to restore the normal blood flow in patients with atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).

Read the detailed description

Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, 6 months and every 6 months until the end of the study.

Being tested
Darapladib 160 mg, Placebo, Standard Therapy
Keywords
Atherosclerosis, Heart disease, Cardiovascular disease, Lp-PLA2 inhibitor, The TIMI Study Group, Coronary Heart Disease (CHD), Acute Coronary Syndrome (ACS)
Medical subject headings
Acute Coronary Syndrome, Atherosclerosis, Heart Diseases, Cardiovascular Diseases, Coronary Disease

What participants receive

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

  • Darapladib 160 mgDrug

    Also called SB-480848

    Lp-PLA2 inhibitor

  • PlaceboDrug

    Placebo administered

  • Standard TherapyOther

    Guideline mandated therapy for individual's condition

Study groups in NCT01000727
Study groupRoleWhat they receive
Darapladib 160 mgExperimentalSingle daily oral tablet
Receives: Drug: Darapladib 160 mg; Other: Standard Therapy
PlaceboPlacebo comparatorSingle daily oral tablet
Receives: Drug: Placebo; Other: Standard Therapy

What is being measured

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

  1. Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event

    Coronary heart disease (CHD) death=occurrence of a fatal myocardial infarction (MI), death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a nonischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent coronary revascularization (CR) for MI=ischemic discomfort at rest that prompted CR during the same hospitalization or resulted in hospital transfer for the purpose of CR.

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

Secondary outcomes (11)

  1. Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal MI or Non-fatal Stroke) During the Time Period for Follow-up of CV Events

    CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

  2. Number of Participants With Cardiovascular Death During the Time Period for Follow-up of Cardiovascular Events

    CV death is defined as a death due to a CV cause, which includes but is not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

  3. Number of Participants With First Occurrence of MI (Fatal/Nonfatal) During the Time Period for Follow-up of Cardiovascular Events

    Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

  4. Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of Cardiovascular Events

    Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

  5. Number of Participants With CHD Death During the Time Period for Follow-up of Cardiovascular Events

    CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

  6. Number of Participants With Urgent Coronary Revascularization for Myocardial Ischemia During the Time Period for Follow-up of Cardiovascular Events

    Urgent coronary revascularization for myocardial ischemia is defined as ischemic discomfort at rest that prompts coronary revascularization (PCI or coronary artery bypass graft [CABG]) during the same hospitalization or resulting in hospital transfer for the purpose of coronary revascularization. PCI is defined as any attempt at revascularization even if not successful (e.g., angioplasty, atherectomy or stenting).

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

  7. Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During the Time Period for FU of CV Events

    CHD death, acute MI, and prior MI diagnosed post-randomization are defined in the primary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort was found not to be caused by myocardial ischemia. Coronary revascularization procedures exclude PCI planned prior to randomization but performed after randomization.

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

  8. Number of Participants With First Occurrence of Any Coronary Revascularization Procedures (Excluding Coronary Revascularization Planned Prior to Randomization, But Performed After Randomization) During the Time Period for Follow-up of Cardiovascular Event

    All coronary revascularization procedures (except for PCI planned prior to randomization but performed after randomization) are included. Examples include coronary artery bypass graft, balloon angioplasty and stenting. The number of participants, with first occurrence of any coronary revascularization procedures, were reported.

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

  9. Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Nonfatal Stroke During the Time Period for Follow-up of Cardiovascular Events

    Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

  10. Number of Participants With First Occurrence of Any Event in the Composite of CHD Death and Non-fatal MI During the Time Period for Follow-up of Cardiovascular Events

    Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

  11. Number of Participants With All-cause Mortality During the Time Period for Vital Status

    Number of participants who died, during the vital status time-period were reported. The participants who were known to have died, date of death was used; for participants who completed the study the study completion date was used; for participants who withdrew from the study where vital status was ascertained , and are known to have not died , the last known date to be alive was used and for participants whom vital status was not ascertained, following study withdrawal the study withdrawal date was used.

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

Timeline

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

  1. First posted23 Oct 2009 (estimated)
  2. Study start1 Dec 2009
  3. Primary completion1 Apr 2014
  4. Study completion24 Apr 2014

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
13,026 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01000727
Sponsor's protocol ID
480848/033
Acronym
SOLID-TIMI 52
Status last verified
Jun 2017
First submitted
22 Oct 2009
Last updated
10 Aug 2017
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Correa S, Morrow DA, Braunwald E, Davies RY, Goodrich EL, Murphy SA, Cannon CP, O'Donoghue ML. Cystatin C for Risk Stratification in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2018 Oct 16;7(20):e009077. doi: 10.1161/JAHA.118.009077.

    PubMed 30371283

  • Barger LK, Rajaratnam SMW, Cannon CP, Lukas MA, Im K, Goodrich EL, Czeisler CA, O'Donoghue ML. Short Sleep Duration, Obstructive Sleep Apnea, Shiftwork, and the Risk of Adverse Cardiovascular Events in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2017 Oct 10;6(10):e006959. doi: 10.1161/JAHA.117.006959.

    PubMed 29018021

  • Eisen A, Cannon CP, Braunwald E, Steen DL, Zhou J, Goodrich EL, Im K, Dalby AJ, Spinar J, Daga S, Lukas MA, O'Donoghue ML. Predictors of Nonuse of a High-Potency Statin After an Acute Coronary Syndrome: Insights From the Stabilization of Plaques Using Darapladib-Thrombolysis in Myocardial Infarction 52 (SOLID-TIMI 52) Trial. J Am Heart Assoc. 2017 Jan 11;6(1):e004332. doi: 10.1161/JAHA.116.004332.

    PubMed 28077384

  • O'Donoghue ML, Braunwald E, White HD, Lukas MA, Tarka E, Steg PG, Hochman JS, Bode C, Maggioni AP, Im K, Shannon JB, Davies RY, Murphy SA, Crugnale SE, Wiviott SD, Bonaca MP, Watson DF, Weaver WD, Serruys PW, Cannon CP; SOLID-TIMI 52 Investigators; Steen DL. Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1006-15. doi: 10.1001/jama.2014.11061.

    PubMed 25173516

  • O'Donoghue ML, Braunwald E, White HD, Serruys P, Steg PG, Hochman J, Maggioni AP, Bode C, Weaver D, Johnson JL, Cicconetti G, Lukas MA, Tarka E, Cannon CP. Study design and rationale for the Stabilization of pLaques usIng Darapladib-Thrombolysis in Myocardial Infarction (SOLID-TIMI 52) trial in patients after an acute coronary syndrome. Am Heart J. 2011 Oct;162(4):613-619.e1. doi: 10.1016/j.ahj.2011.07.018. Epub 2011 Sep 15.

    PubMed 21982651

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darapladib 160 mg and Standard Therapy in people with Acute Coronary Syndrome, run by GlaxoSmithKline at 914 sites in 36 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 11 inclusion and 18 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 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 914 sites in United States, Russia, Netherlands, Germany, Poland and 31 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 10 Aug 2017). 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 Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event (time frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)). 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 NCT01000727, 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 10 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in