Last updated: 07/17/2024 17:39:11
The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 TrialSOLID-TIMI 52
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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).
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: 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:
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
Timeframe: 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)
Number of participants with cardiovascular death during the time period for follow-up of cardiovascular events
Timeframe: 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)
Number of participants with first occurrence of MI (fatal/nonfatal) during the time period for follow-up of cardiovascular events
Timeframe: 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)
Number of participants with first occurrence of stroke (fatal/non-fatal) during the time period for follow-up of cardiovascular events
Timeframe: 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)
Number of participants with CHD death during the time period for follow-up of cardiovascular events
Timeframe: 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)
Number of participants with urgent coronary revascularization for myocardial ischemia during the time period for follow-up of cardiovascular events
Timeframe: 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)
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
Timeframe: 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)
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
Timeframe: 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)
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
Timeframe: 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)
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
Timeframe: 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)
Number of participants with all-cause mortality during the time period for vital status
Timeframe: 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)
Interventions:
Drug: Darapladib 160 mg
Drug: Placebo
Other: Standard Therapy
Enrollment:
13026
Observational study model:
Not applicable
Primary completion date:
2014-24-04
Time perspective:
Not applicable
Clinical publications:
Michelle L. O’Donoghue,MD, MPH; Eugene Braunwald, MD; Harvey D. White, MBChB, DSc; Dylan P. Steen, MD; Mary Ann Lukas, MD; Elizabeth Tarka, MD; P. Gabriel Steg, MD; Judith S. Hochman, MD; et al .Effect of Darapladib on Major Coronary Events After an Acute Coronary Syndrome: The SOLID-TIMI 52 Randomized Clinical Trial.JAMA.2014;312(10):1006-1015
Matthias Wuttke et al (200+ authors).A catalogue of molecular targets for kidney function from genetic 1 analyses of a million individuals.Nat Genet.2019;51:957–972
DOI: 10.1038/s41588-019-0407-x
Medical condition
acute coronary syndrome
Product
darapladib
Collaborators
The TIMI Study Group
Study date(s)
December 2009 to April 2014
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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).
Inclusion and exclusion criteria
Inclusion criteria:
- 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:
- 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.
Exclusion criteria:
- 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.
- 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 location(s)
Location
GSK Investigational Site
Linden, New Jersey, United States, 07036
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000CVD
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Aurora, Illinois, United States, 60504
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Burien, Washington, United States, 98166
Status
Study Complete
Location
GSK Investigational Site
Columbia, Maryland, United States, 21044
Status
Study Complete
Location
GSK Investigational Site
Haddon Heights, New Jersey, United States, 08035
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, Indiana, United States, 46383
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 750 0922
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90211
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Camp Hill, Pennsylvania, United States, 17011
Status
Study Complete
Location
GSK Investigational Site
Gangnam-gu, Seoul, South Korea, 135-710
Status
Study Complete
Location
GSK Investigational Site
Brandon, Florida, United States, 33511
Status
Study Complete
Location
GSK Investigational Site
Kirkland, Washington, United States, 98034
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
Santa Ana, California, United States, 92704
Status
Study Complete
Location
GSK Investigational Site
Mission Hills, California, United States, 91345
Status
Study Complete
Location
GSK Investigational Site
Worcester, Massachusetts, United States, 01655
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90620001
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85306
Status
Study Complete
Location
GSK Investigational Site
Fleming Island, Florida, United States, 32003
Status
Study Complete
Location
GSK Investigational Site
Safety Harbor, Florida, United States, 34695
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93721
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68526
Status
Study Complete
Location
GSK Investigational Site
Bakersfield, California, United States, 93308
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21208
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chertsey, Surrey, United Kingdom, KT16 0PZ
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425AST
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pinehurst, North Carolina, United States, 28374
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45267
Status
Study Complete
Location
GSK Investigational Site
Stony Brook, New York, United States, 11794
Status
Study Complete
Location
GSK Investigational Site
Bloemfontein, Free State, South Africa, 9301
Status
Study Complete
Location
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35243
Status
Study Complete
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
Jersey Shore, Pennsylvania, United States, 17740
Status
Study Complete
Location
GSK Investigational Site
Anchorage, Alaska, United States, 99508
Status
Study Complete
Location
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, B7600FZN
Status
Study Complete
Location
GSK Investigational Site
North Chicago, Illinois, United States, 60064
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40207
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32209
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21229
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46290
Status
Study Complete
Location
GSK Investigational Site
Leetsdale, Pennsylvania, United States, 15056
Status
Study Complete
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35801
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55426
Status
Study Complete
Location
GSK Investigational Site
Votuporanga, São Paulo, Brazil, 15500-003
Status
Study Complete
Location
GSK Investigational Site
Kalispell, Montana, United States, 59901
Status
Study Complete
Location
GSK Investigational Site
Youngstown, Ohio, United States, 44501-1790
Status
Study Complete
Location
GSK Investigational Site
Great Falls, Montana, United States, 59405
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30901
Status
Study Complete
Location
GSK Investigational Site
Scarborough, Maine, United States, 04074
Status
Study Complete
Location
GSK Investigational Site
Gosford, New South Wales, Australia, 2250
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14215
Status
Study Complete
Location
GSK Investigational Site
Cape Town, Western Province, South Africa, 7500
Status
Study Complete
Location
GSK Investigational Site
Galveston, Texas, United States, 77555-0553
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48201
Status
Study Complete
Location
GSK Investigational Site
Panorama, Western Province, South Africa, 7500
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29425
Status
Study Complete
Location
GSK Investigational Site
Marquette, Michigan, United States, 49855
Status
Study Complete
Location
GSK Investigational Site
Bad Krozingen, Baden-Wuerttemberg, Germany, 79189
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71105
Status
Study Complete
Location
GSK Investigational Site
Browns Mills, New Jersey, United States, 08015
Status
Study Complete
Location
GSK Investigational Site
La Mesa, California, United States, 91942
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
York, Pennsylvania, United States, 17405
Status
Study Complete
Location
GSK Investigational Site
Midlothian, Virginia, United States, 23114
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Study Complete
Location
GSK Investigational Site
Wuppertal, Nordrhein-Westfalen, Germany, 42117
Status
Study Complete
Location
GSK Investigational Site
Robbinsdale, Minnesota, United States, 55422
Status
Study Complete
Location
GSK Investigational Site
Allentown, Pennsylvania, United States, 18103
Status
Study Complete
Location
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Status
Study Complete
Location
GSK Investigational Site
San Sebastián de los Reyes/Madrid, Spain
Status
Study Complete
Location
GSK Investigational Site
Columbia, Tennessee, United States, 38401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greeley, Colorado, United States, 80631
Status
Study Complete
Location
GSK Investigational Site
Winchester, Virginia, United States, 22601
Status
Study Complete
Location
GSK Investigational Site
's-Hertogenbosch, Netherlands, 5223 GZ
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, JAV 2GB
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mobile, Alabama, United States, 36604
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bridgeport, Connecticut, United States, 06606
Status
Study Complete
Location
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
Status
Study Complete
Location
GSK Investigational Site
Vero Beach, Florida, United States, 32960
Status
Study Complete
Location
GSK Investigational Site
Duluth, Minnesota, United States, 55805
Status
Study Complete
Location
GSK Investigational Site
Rock Island, Illinois, United States, 61201
Status
Study Complete
Location
GSK Investigational Site
Ayer, Massachusetts, United States, 01432
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hollywood, Florida, United States, 33021
Status
Study Complete
Location
GSK Investigational Site
Lafayette, Louisiana, United States, 70506
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90509
Status
Study Complete
Location
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Glendale, California, United States, 91204
Status
Study Complete
Location
GSK Investigational Site
Sarasota, Florida, United States, 34232
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 05508-900
Status
Study Complete
Location
GSK Investigational Site
Surrey, British Columbia, Canada, V3V 1N1
Status
Study Complete
Location
GSK Investigational Site
Oldenburg, Niedersachsen, Germany, 26133
Status
Study Complete
Location
GSK Investigational Site
Middleburg Heights, Ohio, United States, 44130
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33604
Status
Study Complete
Location
GSK Investigational Site
Alexandria, Louisiana, United States, 71301
Status
Study Complete
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
West Des Moines, Iowa, United States, 50266
Status
Study Complete
Location
GSK Investigational Site
Plantation, Florida, United States, 33317
Status
Study Complete
Location
GSK Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Landsdale, Pennsylvania, United States, 19446
Status
Study Complete
Location
GSK Investigational Site
Cortlandt Manor, New York, United States, 10567
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46237
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 05403000
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10001
Status
Study Complete
Location
GSK Investigational Site
Mokena, Illinois, United States, 60448
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Talcahuano, Región Del Biobio, Chile, 427 0918
Status
Study Complete
Location
GSK Investigational Site
Port Charlotte, Florida, United States, 33952
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Status
Study Complete
Location
GSK Investigational Site
Exeter, Devon, United Kingdom, EX2 5DW
Status
Study Complete
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Location
GSK Investigational Site
Catanzaro, Calabria, Italy, 88100
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbia, Montana, United States, 65201
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29607
Status
Study Complete
Location
GSK Investigational Site
Johannesburg, Gauteng, South Africa, 2000
Status
Study Complete
Location
GSK Investigational Site
Sugar Land, Texas, United States, 77479
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41464
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kissimmee, Florida, United States, 34741
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Miramar, Florida, United States, 33025
Status
Study Complete
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 21041-030
Status
Study Complete
Location
GSK Investigational Site
Hammond, Indiana, United States, 46320
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90015
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Eschweiler, Nordrhein-Westfalen, Germany, 52249
Status
Study Complete
Location
GSK Investigational Site
Gastonia, North Carolina, United States, 28054
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53713
Status
Study Complete
Location
GSK Investigational Site
New Westminister, British Columbia, Canada, V3L 3W4
Status
Study Complete
Location
GSK Investigational Site
Round Rock, Texas, United States, 78681
Status
Study Complete
Location
GSK Investigational Site
Concord, North Carolina, United States, 28025
Status
Study Complete
Location
GSK Investigational Site
Goiânia - GO, Goiás, Brazil, 74605-020
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
Nizhniy Novgorod, Russia, 603035
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hartford, Connecticut, United States, 06067
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
Status
Study Complete
Location
GSK Investigational Site
Scranton, Pennsylvania, United States, 18501
Status
Study Complete
Location
GSK Investigational Site
Tyler, Texas, United States, 75708
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21201
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75390-8887
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16502
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27610
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Munster, Indiana, United States, 46321
Status
Study Complete
Location
GSK Investigational Site
Northampton, Northamptonshire, United Kingdom, NN1 5BD
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19141
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sellersville, Pennsylvania, United States, 18960
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131-0001
Status
Study Complete
Location
GSK Investigational Site
Sao Paulo, São Paulo, Brazil, 04024-900
Status
Study Complete
Location
GSK Investigational Site
Tupelo, Mississippi, United States, 38801
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95819
Status
Study Complete
Location
GSK Investigational Site
Everett, Washington, United States, 98201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Paterson, New Jersey, United States, 07503
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ramos Mejia, Buenos Aires, Argentina, B1704ETD
Status
Study Complete
Location
GSK Investigational Site
kansas City, Missouri, United States, 64114
Status
Study Complete
Location
GSK Investigational Site
San Daniele del Friuli, Friuli-Venezia-Giulia, Italy, 33038
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02111
Status
Study Complete
Location
GSK Investigational Site
Oakbrook Terrace, Illinois, United States, 60181
Status
Study Complete
Location
GSK Investigational Site
Bel Air, Maryland, United States, 21014
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
Status
Study Complete
Location
GSK Investigational Site
Natal, Rio Grande Du Norte, Brazil, 59020-100
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04012-180
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
Campina Grande do Sul, Paraná, Brazil, 83430000
Status
Study Complete
Location
GSK Investigational Site
Rio De Janeiro, Rio De Janeiro, Brazil, RJ 22240-000
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11219
Status
Study Complete
Location
GSK Investigational Site
Rapid City, South Dakota, United States, 57701
Status
Study Complete
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01199
Status
Study Complete
Location
GSK Investigational Site
Brampton, Ontario, Canada, L6Z 4N5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Justo, Buenos Aires, Argentina, B1754FPI
Status
Study Complete
Location
GSK Investigational Site
Ventura, California, United States, 93003
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Marcos, Texas, United States, 78666
Status
Study Complete
Location
GSK Investigational Site
St.Louis, Missouri, United States, 63128
Status
Study Complete
Location
GSK Investigational Site
Elmer, New Jersey, United States, 8318
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Daytona Beach, Florida, United States, 32114
Status
Study Complete
Location
GSK Investigational Site
Atlantis, Florida, United States, 33462
Status
Study Complete
Location
GSK Investigational Site
Townson, Maryland, United States, 21204
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Guilford, Connecticut, United States, 06437
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
Lomita, California, United States, 90717
Status
Study Complete
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37404
Status
Study Complete
Location
GSK Investigational Site
Oklahoma, Oklahoma, United States, 73104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
Status
Study Complete
Location
GSK Investigational Site
Canton, Ohio, United States, 44718
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Diego, California, United States, 92161
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12211
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Washington, United States, 98004
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
Status
Study Complete
Location
GSK Investigational Site
Matthews, North Carolina, United States, 28105
Status
Study Complete
Location
GSK Investigational Site
Bethlehem, Pennsylvania, United States, 18015
Status
Study Complete
Location
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
Status
Study Complete
Location
GSK Investigational Site
Papillion, Nebraska, United States, 68046
Status
Study Complete
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28803
Status
Study Complete
Location
GSK Investigational Site
Melrose Park, Illinois, United States, 60160
Status
Study Complete
Location
GSK Investigational Site
Torquay, Devon, United Kingdom, TQ2 7AA
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80920
Status
Study Complete
Location
GSK Investigational Site
San Martin de Porres, Lima, Peru, Lima 31
Status
Study Complete
Location
GSK Investigational Site
Dearborn, Michigan, United States, 48124
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32610
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29401
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32501
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70376
Status
Study Complete
Location
GSK Investigational Site
Sayre, Pennsylvania, United States, 18840
Status
Study Complete
Location
GSK Investigational Site
Jackson, Tennessee, United States, 38085
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15240
Status
Study Complete
Location
GSK Investigational Site
Cape Town, Western Province, South Africa, 7530
Status
Study Complete
Location
GSK Investigational Site
Crestview Hill, Kentucky, United States, 41017
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Peoria, Illinois, United States, 61614
Status
Study Complete
Location
GSK Investigational Site
Rocky Mount, North Carolina, United States, 27804
Status
Study Complete
Location
GSK Investigational Site
Grand Forks, North Dakota, United States, 58201
Status
Study Complete
Location
GSK Investigational Site
Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
Status
Study Complete
Location
GSK Investigational Site
Jackson, Tennessee, United States, 38301
Status
Study Complete
Location
GSK Investigational Site
Jupiter, Florida, United States, 33458
Status
Study Complete
Location
GSK Investigational Site
Palmanova, Friuli-Venezia-Giulia, Italy, 33057
Status
Study Complete
Location
GSK Investigational Site
Coventry, West Midlands, United Kingdom, CV2 2DX
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37604
Status
Study Complete
Location
GSK Investigational Site
Cottonwood, Arizona, United States, 86326
Status
Study Complete
Location
GSK Investigational Site
Bannockburn, Illinois, United States, 60015
Status
Study Complete
Location
GSK Investigational Site
Salisbury, Maryland, United States, 21801
Status
Study Complete
Location
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32207
Status
Study Complete
Location
GSK Investigational Site
Dunkerque, Nord-Pas-de-Calais, France, 59240
Status
Study Complete
Location
GSK Investigational Site
Los Alamitos, California, United States, 90720
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Status
Study Complete
Location
GSK Investigational Site
Golden, Colorado, United States, 80401
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204-2334
Status
Study Complete
Location
GSK Investigational Site
Durban, KwaZulu- Natal, South Africa, 4052
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Trinity, Florida, United States, 34655
Status
Study Complete
Location
GSK Investigational Site
Columbia, Missouri, United States, 65212
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
Status
Study Complete
Location
GSK Investigational Site
Concepción, Región Del Biobio, Chile, 56-41
Status
Study Complete
Location
GSK Investigational Site
Springfield, Missouri, United States, 65804
Status
Study Complete
Location
GSK Investigational Site
Huntersville, North Carolina, United States, 28078
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77124
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90880-480
Status
Study Complete
Location
GSK Investigational Site
Bellingham, Washington, United States, 98225
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Burlington, North Carolina, United States, 27215
Status
Study Complete
Location
GSK Investigational Site
Fremantle, Western Australia, Australia, 6160
Status
Study Complete
Location
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1180AAX
Status
Study Complete
Location
GSK Investigational Site
Pelotas, Rio Grande Do Sul, Brazil, 96015-290
Status
Study Complete
Location
GSK Investigational Site
Thetford Mines, Québec, Canada, G6G 2V4
Status
Study Complete
Location
GSK Investigational Site
Doylestown, Pennsylvania, United States, 18901
Status
Study Complete
Location
GSK Investigational Site
Fall River, Massachusetts, United States, 02720
Status
Study Complete
Location
GSK Investigational Site
St Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Lake Charles, Louisiana, United States, 70601
Status
Study Complete
Location
GSK Investigational Site
Walla Walla, Washington, United States, 99362
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Airdrie, Lanarkshire, United Kingdom, ML6 0JS
Status
Study Complete
Location
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40205
Status
Study Complete
Location
GSK Investigational Site
Palm Beach Gardens, Florida, United States, 33410
Status
Study Complete
Location
GSK Investigational Site
Campbell River, British Columbia, Canada, V9W 5Y4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Syracuse, New York, United States, 13202
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pomona, New Jersey, United States, 8240
Status
Study Complete
Location
GSK Investigational Site
Jenkintown, Pennsylvania, United States, 19046
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Littleton, Colorado, United States, 80120
Status
Study Complete
Location
GSK Investigational Site
Usti nad Orlici, Czech Republic, 562 18
Status
Study Complete
Location
GSK Investigational Site
Somerset, New Jersey, United States, 08873
Status
Study Complete
Location
GSK Investigational Site
Harker Heights, Texas, United States, 76548
Status
Study Complete
Location
GSK Investigational Site
Bad Rothenfelde, Niedersachsen, Germany, 49214
Status
Study Complete
Location
GSK Investigational Site
Grand Island, Nebraska, United States, 68803
Status
Study Complete
Location
GSK Investigational Site
Jacksonville Beach, Florida, United States, 32250
Status
Study Complete
Location
GSK Investigational Site
Gulf Breeze, Florida, United States, 32561
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29204
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Santa Ana, California, United States, 92705
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi/Texas, Texas, United States, 78404
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0294
Status
Study Complete
Location
GSK Investigational Site
San Nicolas, Buenos Aires, Argentina, B2900DMH
Status
Study Complete
Location
GSK Investigational Site
St Cloud, Minnesota, United States, 56303
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221.
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
Status
Study Complete
Location
GSK Investigational Site
Monroe, North Carolina, United States, 28112
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21236
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
Status
Study Complete
Location
GSK Investigational Site
Cumming, Georgia, United States, 30041
Status
Study Complete
Location
GSK Investigational Site
Fairview Park, Ohio, United States, 44126
Status
Study Complete
Location
GSK Investigational Site
Oakbrook Terrace, Ohio, United States, 60181
Status
Study Complete
Location
GSK Investigational Site
West Chester, Pennsylvania, United States, 19380
Status
Study Complete
Location
GSK Investigational Site
Rozzano (Mi), Lombardia, Italy, 20089
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46804
Status
Study Complete
Location
GSK Investigational Site
Bridgeport, Connecticut, United States, 06610
Status
Study Complete
Location
GSK Investigational Site
Inverness, Florida, United States, 34452
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucuman, Argentina, T4000IFL
Status
Study Complete
Location
GSK Investigational Site
Bakersfield, California, United States, 93309
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8R 4R2
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30130-110
Status
Study Complete
Location
GSK Investigational Site
Thousand Oaks, California, United States, 91360
Status
Study Complete
Location
GSK Investigational Site
Wausau, Wisconsin, United States, 54401
Status
Study Complete
Location
GSK Investigational Site
Summit, New Jersey, United States, 07902
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95661
Status
Study Complete
Location
GSK Investigational Site
Chambersburg, Pennsylvania, United States, 17201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oak Ridge, Tennessee, United States, 37830
Status
Study Complete
Location
GSK Investigational Site
Pontiac, Michigan, United States, 48341-2985
Status
Study Complete
Location
GSK Investigational Site
Midwest City, Oklahoma, United States, 73110
Status
Study Complete
Location
GSK Investigational Site
Joplin, Missouri, United States, 64804
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Orange, New Jersey, United States, 07052
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Durban, KwaZulu- Natal, South Africa, 4001
Status
Study Complete
Location
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33713
Status
Study Complete
Location
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
Status
Study Complete
Location
GSK Investigational Site
Beaver, Pennsylvania, United States, 15009
Status
Study Complete
Location
GSK Investigational Site
Wellington, Florida, United States, 33449
Status
Study Complete
Location
GSK Investigational Site
Fort Smith, Arkansas, United States, 72903
Status
Study Complete
Location
GSK Investigational Site
Williamsville, New York, United States, 14221
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23249
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90073
Status
Study Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Status
Study Complete
Location
GSK Investigational Site
Alberton, Gauteng, South Africa, 1449
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Daytona Beach, Florida, United States, 32117
Status
Study Complete
Location
GSK Investigational Site
Sanford, North Carolina, United States, 27330
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23298
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saint Paul, Minnesota, United States, 55101
Status
Study Complete
Location
GSK Investigational Site
Roslyn, New York, United States, 11576
Status
Study Complete
Location
GSK Investigational Site
Quincy sous Sénart, France, 91480
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portland, Oregon, United States, 97220
Status
Study Complete
Location
GSK Investigational Site
Lancaster, Pennsylvania, United States, 17604
Status
Study Complete
Location
GSK Investigational Site
Green Bay, Wisconsin, United States, 54301
Status
Study Complete
Location
GSK Investigational Site
Stockton, California, United States, 95204
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH
Status
Study Complete
Location
GSK Investigational Site
Elizabeth, New Jersey, United States, 07202
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
São José do Rio Preto, São Paulo, Brazil, 15015210
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46601-1066
Status
Study Complete
Location
GSK Investigational Site
Sewell, New Jersey, United States, 08080
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Status
Study Complete
Location
GSK Investigational Site
East Kilbride, United Kingdom, G75 8RG
Status
Study Complete
Location
GSK Investigational Site
Lynchburg, Virginia, United States, 24501
Status
Study Complete
Location
GSK Investigational Site
Towson, Maryland, United States, 21204
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21218
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Haedo, Buenos Aires, Argentina, B1706AJU
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Langres, Champagne-Ardenne, France, 52206
Status
Study Complete
Location
GSK Investigational Site
Beloit, Wisconsin, United States, 53511
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Corrientes, Corrientes, Argentina, W3400AMZ
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Study Complete
Location
GSK Investigational Site
Elizabeth Vale, South Australia, Australia, 5112
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2014-24-04
Actual study completion date
2014-24-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
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