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

Acute Coronary Syndrome Clinical Trial

— SOLID-TIMI 52  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000727
• Other study ID #: 480848/033
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2009
• Last updated: March 21, 2017
• Start date: December 2009
• Est. completion date: April 2014

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 acute coronary syndrome (also called ACS).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13026
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Darapladib 160 mg
Lp-PLA2 inhibitor
• Placebo
Placebo administered

Other:
• Standard Therapy
Guideline mandated therapy for individual's condition

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Cipolletti
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	Corrientes
Argentina	GSK Investigational Site	Haedo, Buenos Aires
Argentina	GSK Investigational Site	Mar del Plata	Buenos Aires
Argentina	GSK Investigational Site	Ramos Mejia	Buenos Aires
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	San Justo	Buenos Aires
Argentina	GSK Investigational Site	San Miguel de Tucuman
Argentina	GSK Investigational Site	San Nicolas	Buenos Aires
Argentina	GSK Investigational Site	Santa fe
Argentina	GSK Investigational Site	Sante Fe
Argentina	GSK Investigational Site	Sante Fe
Argentina	GSK Investigational Site	Tucuman
Argentina	GSK Investigational Site	Zárate
Australia	GSK Investigational Site	Adelaide	South Australia
Australia	GSK Investigational Site	Ashford
Australia	GSK Investigational Site	Auchenflower	Queensland
Australia	GSK Investigational Site	Box Hill	Victoria
Australia	GSK Investigational Site	Camperdown	New South Wales
Australia	GSK Investigational Site	Elizabeth Vale	South Australia
Australia	GSK Investigational Site	Fremantle	Western Australia
Australia	GSK Investigational Site	Garran	Australian Capital Territory
Australia	GSK Investigational Site	Gosford	New South Wales
Australia	GSK Investigational Site	Herston	Queensland
Australia	GSK Investigational Site	Hobart	Tasmania
Australia	GSK Investigational Site	Milton	Queensland
Australia	GSK Investigational Site	Nedlands	Victoria
Belgium	GSK Investigational Site	Aalst
Belgium	GSK Investigational Site	Bonheiden
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Genk
Belgium	GSK Investigational Site	La Louvière
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Liège
Belgium	GSK Investigational Site	Roeselaere
Brazil	GSK Investigational Site	Bahia
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais
Brazil	GSK Investigational Site	Brasília
Brazil	GSK Investigational Site	Campina Grande do Sul	Paraná
Brazil	GSK Investigational Site	Campinas
Brazil	GSK Investigational Site	Campo Grande
Brazil	GSK Investigational Site	Curitiba	Paraná
Brazil	GSK Investigational Site	Fortaleza	Ceará
Brazil	GSK Investigational Site	Goiânia - GO	Goiás
Brazil	GSK Investigational Site	Marília	São Paulo
Brazil	GSK Investigational Site	Natal	Rio Grande Du Norte
Brazil	GSK Investigational Site	Pelotas	Rio Grande Do Sul
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Rio de Janeiro
Brazil	GSK Investigational Site	Rio De Janeiro
Brazil	GSK Investigational Site	Salvador	Bahía
Brazil	GSK Investigational Site	Sao Jose do Rio Preto	São Paulo
Brazil	GSK Investigational Site	São José do Rio Preto	São Paulo
Brazil	GSK Investigational Site	Sao Paulo	São Paulo
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo - SP
Brazil	GSK Investigational Site	Uberlandia
Brazil	GSK Investigational Site	Votuporanga	São Paulo
Bulgaria	GSK Investigational Site	Dimitrovgrad
Bulgaria	GSK Investigational Site	Haskovo
Bulgaria	GSK Investigational Site	Pleven
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Veliko Tarnovo
Canada	GSK Investigational Site	Ajax	Ontario
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Cambridge	Ontario
Canada	GSK Investigational Site	Cambridge	Ontario
Canada	GSK Investigational Site	Campbell River	British Columbia
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Kelowna	Ontario
Canada	GSK Investigational Site	Longueuil	Quebec
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	New Westminister	British Columbia
Canada	GSK Investigational Site	Newmarket	Ontario
Canada	GSK Investigational Site	Oshawa	Ontario
Canada	GSK Investigational Site	Oshawa	Ontario
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Sarnia	Ontario
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	St. John's	Newfoundland and Labrador
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Thetford Mines	Quebec
Canada	GSK Investigational Site	Thunder Bay	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
Chile	GSK Investigational Site	Concepción	Región Del Biobio
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago
Chile	GSK Investigational Site	Santiago
Chile	GSK Investigational Site	Talcahuano	Región Del Biobio
Chile	GSK Investigational Site	Temuco
Chile	GSK Investigational Site	Temuco	Región De La Araucania
Chile	GSK Investigational Site	Viña del Mar	Valparaíso
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Chengdu	Sichuan
China	GSK Investigational Site	Dalian	Liaoning
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Haikou	Hainan
China	GSK Investigational Site	Hangzhou	Zhejiang
China	GSK Investigational Site	Hangzhou
China	GSK Investigational Site	Jinan
China	GSK Investigational Site	Jinan	Shandong
China	GSK Investigational Site	Lanzhou	Gansu
China	GSK Investigational Site	Nanjing	Jiangsu
China	GSK Investigational Site	Nanning	Guangxi
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shenyang	Liaoning
China	GSK Investigational Site	Shenyang	Liaoning
China	GSK Investigational Site	Shijiazhuang	Hebei
China	GSK Investigational Site	Suzhou
China	GSK Investigational Site	Xian	Shaanxi
Colombia	GSK Investigational Site	Armenia
Colombia	GSK Investigational Site	Barranquilla
Colombia	GSK Investigational Site	Bogota
Colombia	GSK Investigational Site	Bogota
Colombia	GSK Investigational Site	Bogota
Colombia	GSK Investigational Site	Bogotá
Colombia	GSK Investigational Site	Bucaramanga
Colombia	GSK Investigational Site	Cartagena
Colombia	GSK Investigational Site	Manizales
Colombia	GSK Investigational Site	Medellin
Colombia	GSK Investigational Site	Medellín
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Caslav
Czech Republic	GSK Investigational Site	Jihlava
Czech Republic	GSK Investigational Site	Kromeriz
Czech Republic	GSK Investigational Site	Milevsko
Czech Republic	GSK Investigational Site	Olomouc
Czech Republic	GSK Investigational Site	Plzen - Bory
Czech Republic	GSK Investigational Site	Praha 10
Czech Republic	GSK Investigational Site	Praha 2
Czech Republic	GSK Investigational Site	Slany
Czech Republic	GSK Investigational Site	Svitavy
Czech Republic	GSK Investigational Site	Usti nad Orlici
Czech Republic	GSK Investigational Site	Zlin
Denmark	GSK Investigational Site	Aalborg
Denmark	GSK Investigational Site	Aarhus
Denmark	GSK Investigational Site	Esbjerg
Denmark	GSK Investigational Site	Frederikssund
Denmark	GSK Investigational Site	Glostrup
Denmark	GSK Investigational Site	Hellerup
Denmark	GSK Investigational Site	Herlev
Denmark	GSK Investigational Site	Holbæk
Denmark	GSK Investigational Site	Hvidovre
Denmark	GSK Investigational Site	København NV
Denmark	GSK Investigational Site	København S
Denmark	GSK Investigational Site	Koebenhavn N
Denmark	GSK Investigational Site	Køge
Denmark	GSK Investigational Site	Kolding
Denmark	GSK Investigational Site	Næstved
Denmark	GSK Investigational Site	Odense C
Denmark	GSK Investigational Site	Roskilde
Denmark	GSK Investigational Site	Silkeborg
Denmark	GSK Investigational Site	Svendborg
France	GSK Investigational Site	Avignon
France	GSK Investigational Site	Besançon Cedex
France	GSK Investigational Site	Bron
France	GSK Investigational Site	Créteil
France	GSK Investigational Site	Dijon Cedex
France	GSK Investigational Site	Dunkerque	Nord-Pas-de-Calais
France	GSK Investigational Site	Lagny sur Marne
France	GSK Investigational Site	Langres	Champagne-Ardenne
France	GSK Investigational Site	Le Plessis Robinson
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Marseille Cedex 08
France	GSK Investigational Site	Montfermeil
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris Cedex 18
France	GSK Investigational Site	Pau	Aquitaine
France	GSK Investigational Site	Poitiers
France	GSK Investigational Site	Quincy sous Sénart
France	GSK Investigational Site	Rennes
France	GSK Investigational Site	Strasbourg Cedex
France	GSK Investigational Site	Toulouse
France	GSK Investigational Site	Tourcoing
France	GSK Investigational Site	Valenciennes
Germany	GSK Investigational Site	Altenburg	Thueringen
Germany	GSK Investigational Site	Bad Krozingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Bad Nauheim	Hessen
Germany	GSK Investigational Site	Bad Rothenfelde	Niedersachsen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bielefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bremen
Germany	GSK Investigational Site	Darmstadt	Hessen
Germany	GSK Investigational Site	Eschweiler	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Halle
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Homburg	Saarland
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Langen	Hessen
Germany	GSK Investigational Site	Limburg	Hessen
Germany	GSK Investigational Site	Ludwigshafen	Rheinland-Pfalz
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Neuss	Nordrhein-Westfalen
Germany	GSK Investigational Site	Oldenburg	Niedersachsen
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ulm	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wuppertal	Nordrhein-Westfalen
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Cegléd
Hungary	GSK Investigational Site	Eger
Hungary	GSK Investigational Site	Gyula
Hungary	GSK Investigational Site	Hodmezovasarhely
Hungary	GSK Investigational Site	Kistarcsa
Hungary	GSK Investigational Site	Miskolc
Hungary	GSK Investigational Site	Székesfehérvár
Hungary	GSK Investigational Site	Szolnok
Hungary	GSK Investigational Site	Szombathely
Hungary	GSK Investigational Site	Zalaegerszeg
India	GSK Investigational Site	Ahmedabad
India	GSK Investigational Site	Ahmedabad
India	GSK Investigational Site	Amritsar
India	GSK Investigational Site	Chennai
India	GSK Investigational Site	Chennai
India	GSK Investigational Site	Faridabad
India	GSK Investigational Site	Gandhinagar
India	GSK Investigational Site	Gurgaon
India	GSK Investigational Site	Hyderabad
India	GSK Investigational Site	Hyderabad
India	GSK Investigational Site	Hyderabad
India	GSK Investigational Site	Hyderabad
India	GSK Investigational Site	Hyderabad
India	GSK Investigational Site	Indore
India	GSK Investigational Site	Jaipur
India	GSK Investigational Site	Lucknow
India	GSK Investigational Site	Mohali
India	GSK Investigational Site	New Delhi
India	GSK Investigational Site	New Delhi
India	GSK Investigational Site	New Delhi
India	GSK Investigational Site	Noida
India	GSK Investigational Site	Patiala
India	GSK Investigational Site	Pune
India	GSK Investigational Site	Pune,
India	GSK Investigational Site	Secunderabad,
India	GSK Investigational Site	Vadodara
India	GSK Investigational Site	Visakhapatnam
Israel	GSK Investigational Site	Ashkelon
Israel	GSK Investigational Site	Beer Sheva
Israel	GSK Investigational Site	Haddera
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Holon
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Kfar Saba
Israel	GSK Investigational Site	Nahariya
Israel	GSK Investigational Site	Poriya
Israel	GSK Investigational Site	Raanana
Israel	GSK Investigational Site	Ramat-Gan
Israel	GSK Investigational Site	Rehovot
Israel	GSK Investigational Site	Safed
Israel	GSK Investigational Site	Tel Aviv
Italy	GSK Investigational Site	Ascoli Piceno	Marche
Italy	GSK Investigational Site	Bergamo	Lombardia
Italy	GSK Investigational Site	Bologna	Emilia-Romagna
Italy	GSK Investigational Site	Carpi	Emilia-Romagna
Italy	GSK Investigational Site	Catanzaro	Calabria
Italy	GSK Investigational Site	Ferrara	Emilia-Romagna
Italy	GSK Investigational Site	Legnano
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Novara	Piemonte
Italy	GSK Investigational Site	Palmanova	Friuli-Venezia-Giulia
Italy	GSK Investigational Site	Parma	Emilia-Romagna
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Rozzano (Mi)	Lombardia
Italy	GSK Investigational Site	San Daniele del Friuli	Friuli-Venezia-Giulia
Italy	GSK Investigational Site	Sassari	Sardegna
Italy	GSK Investigational Site	Sassuolo
Italy	GSK Investigational Site	Treviso	Veneto
Italy	GSK Investigational Site	Udine	Friuli-Venezia-Giulia
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Nagasaki
Japan	GSK Investigational Site	Oita
Japan	GSK Investigational Site	Okayama
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Saga
Japan	GSK Investigational Site	Shizuoka
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Korea, Republic of	GSK Investigational Site	Dae-Gu
Korea, Republic of	GSK Investigational Site	Daejeon
Korea, Republic of	GSK Investigational Site	Gangnam-gu, Seoul
Korea, Republic of	GSK Investigational Site	Gwangju
Korea, Republic of	GSK Investigational Site	Kangwon-do
Korea, Republic of	GSK Investigational Site	Pusan
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Netherlands	GSK Investigational Site	's-Hertogenbosch
Netherlands	GSK Investigational Site	Amersfoort
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Apeldoorn
Netherlands	GSK Investigational Site	Blaricum
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Deventer
Netherlands	GSK Investigational Site	Dirksland
Netherlands	GSK Investigational Site	Doetinchem
Netherlands	GSK Investigational Site	Drachten
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Gorinchem
Netherlands	GSK Investigational Site	Gouda
Netherlands	GSK Investigational Site	Groningen
Netherlands	GSK Investigational Site	Hardenberg
Netherlands	GSK Investigational Site	Harderwijk
Netherlands	GSK Investigational Site	Heerenveen
Netherlands	GSK Investigational Site	Heerlen
Netherlands	GSK Investigational Site	Helmond
Netherlands	GSK Investigational Site	Hilversum
Netherlands	GSK Investigational Site	Hoofddorp
Netherlands	GSK Investigational Site	Hoorn
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	OSS
Netherlands	GSK Investigational Site	Roermond
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Sittard-geleen
Netherlands	GSK Investigational Site	Sneek
Netherlands	GSK Investigational Site	Tiel
Netherlands	GSK Investigational Site	Tilburg
Netherlands	GSK Investigational Site	Veldhoven
Netherlands	GSK Investigational Site	Venlo
Netherlands	GSK Investigational Site	Zoetermeer
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Dunedin
New Zealand	GSK Investigational Site	Hamilton
New Zealand	GSK Investigational Site	Lower Hutt
New Zealand	GSK Investigational Site	New Plymouth
New Zealand	GSK Investigational Site	Palmerston North
New Zealand	GSK Investigational Site	Takapuna, Auckland
New Zealand	GSK Investigational Site	Tauranga
New Zealand	GSK Investigational Site	Whangarei
Peru	GSK Investigational Site	Callao
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima Cercado
Peru	GSK Investigational Site	Miraflores, Lima	Lima
Peru	GSK Investigational Site	San Martin de Porres	Lima
Philippines	GSK Investigational Site	Cebu City
Philippines	GSK Investigational Site	Davao
Philippines	GSK Investigational Site	Manila
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Quezon City
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Bytom
Poland	GSK Investigational Site	Chrzanow
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Gdynia
Poland	GSK Investigational Site	Gdynia
Poland	GSK Investigational Site	Gdynia
Poland	GSK Investigational Site	Inowroclaw
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lubin
Poland	GSK Investigational Site	Mielec
Poland	GSK Investigational Site	Olawa
Poland	GSK Investigational Site	Opole
Poland	GSK Investigational Site	Radom
Poland	GSK Investigational Site	Skierniewice
Poland	GSK Investigational Site	Tarnow
Poland	GSK Investigational Site	Torun
Poland	GSK Investigational Site	Tychy
Poland	GSK Investigational Site	Walbrzych
Poland	GSK Investigational Site	Warsaw
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wloclawek
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Zamosc
Poland	GSK Investigational Site	Zielona Gora
Romania	GSK Investigational Site	Baia Mare
Romania	GSK Investigational Site	Braila
Romania	GSK Investigational Site	Brasov
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Cluj-Napoca
Romania	GSK Investigational Site	Constanta
Romania	GSK Investigational Site	Craiova
Romania	GSK Investigational Site	Iasi
Romania	GSK Investigational Site	Targu Mures
Russian Federation	GSK Investigational Site	Barnaul
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Gatchina
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Krasnoyarsk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Nizhniy Novgorod
Russian Federation	GSK Investigational Site	Nizhniy Novgorod
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Orenburg
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	Saratov
Russian Federation	GSK Investigational Site	Saratov
Russian Federation	GSK Investigational Site	St'Petersburg
Russian Federation	GSK Investigational Site	St-Petersburg
Russian Federation	GSK Investigational Site	St-Petersburg
Russian Federation	GSK Investigational Site	St-Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Tyumen
Russian Federation	GSK Investigational Site	Tyumen
Russian Federation	GSK Investigational Site	Yaroslavl
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Nitra
Slovakia	GSK Investigational Site	Nitra
Slovakia	GSK Investigational Site	Nove Zamky
South Africa	GSK Investigational Site	Alberton	Gauteng
South Africa	GSK Investigational Site	Bloemfontein	Free State
South Africa	GSK Investigational Site	Cape Town	Western Province
South Africa	GSK Investigational Site	Cape Town	Western Province
South Africa	GSK Investigational Site	Durban	KwaZulu- Natal
South Africa	GSK Investigational Site	Durban	KwaZulu- Natal
South Africa	GSK Investigational Site	Goodwood
South Africa	GSK Investigational Site	Johannesburg	Gauteng
South Africa	GSK Investigational Site	Kempton Park
South Africa	GSK Investigational Site	Paarl
South Africa	GSK Investigational Site	Panorama	Western Province
South Africa	GSK Investigational Site	Parktown West
South Africa	GSK Investigational Site	Parow
South Africa	GSK Investigational Site	Pretoria
South Africa	GSK Investigational Site	Pretoria
South Africa	GSK Investigational Site	Pretoria	Gauteng
South Africa	GSK Investigational Site	Pretoria	Gauteng
South Africa	GSK Investigational Site	Somerset West
South Africa	GSK Investigational Site	Worcester
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	León
Spain	GSK Investigational Site	Lerida
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Oviedo
Spain	GSK Investigational Site	San Juan/Alicante
Spain	GSK Investigational Site	San Sebastián
Spain	GSK Investigational Site	San Sebastián de los Reyes/Madrid
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Vigo/Pontevedra
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Hässleholm
Sweden	GSK Investigational Site	Jönköping
Sweden	GSK Investigational Site	Örebro
Sweden	GSK Investigational Site	Östersund
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Västerås
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Kaohsiung City
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Yung Kang City
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkoknoi
Thailand	GSK Investigational Site	Chiangmai
Thailand	GSK Investigational Site	Khon Kaen, Muang
Thailand	GSK Investigational Site	Nakhon Ratchasima
Thailand	GSK Investigational Site	Pathumthani
Turkey	GSK Investigational Site	Ankara
Turkey	GSK Investigational Site	Erzurum
Turkey	GSK Investigational Site	Eskisehir
Turkey	GSK Investigational Site	Izmir
Turkey	GSK Investigational Site	Izmir
Turkey	GSK Investigational Site	Izmir
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Lugansk
Ukraine	GSK Investigational Site	Lutsk
Ukraine	GSK Investigational Site	Mykolaiv
Ukraine	GSK Investigational Site	Odesa
Ukraine	GSK Investigational Site	Simferopol
Ukraine	GSK Investigational Site	Vinnytsia
Ukraine	GSK Investigational Site	Vinnytsia
Ukraine	GSK Investigational Site	Zaporizhzhya
United Kingdom	GSK Investigational Site	Airdrie	Lanarkshire
United Kingdom	GSK Investigational Site	Antrim
United Kingdom	GSK Investigational Site	Chertsey	Surrey
United Kingdom	GSK Investigational Site	Chichester
United Kingdom	GSK Investigational Site	Coventry	West Midlands
United Kingdom	GSK Investigational Site	East Kilbride
United Kingdom	GSK Investigational Site	Exeter	Devon
United Kingdom	GSK Investigational Site	Harrow	Middlesex
United Kingdom	GSK Investigational Site	Hertfordshire
United Kingdom	GSK Investigational Site	Liverpool
United Kingdom	GSK Investigational Site	Northampton	Northamptonshire
United Kingdom	GSK Investigational Site	Nottingham	Nottinghamshire
United Kingdom	GSK Investigational Site	Paisley
United Kingdom	GSK Investigational Site	Stirling
United Kingdom	GSK Investigational Site	Torquay	Devon
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Alexandria	Louisiana
United States	GSK Investigational Site	Allentown	Pennsylvania
United States	GSK Investigational Site	Amarillo	Texas
United States	GSK Investigational Site	Anchorage	Alaska
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Asheville	North Carolina
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlantis	Florida
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Aurora	Illinois
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Aventura	Florida
United States	GSK Investigational Site	Avon	Indiana
United States	GSK Investigational Site	Ayer	Massachusetts
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bangor	Maine
United States	GSK Investigational Site	Bannockburn	Illinois
United States	GSK Investigational Site	Beaver	Pennsylvania
United States	GSK Investigational Site	Bel Air	Maryland
United States	GSK Investigational Site	Bellevue	Washington
United States	GSK Investigational Site	Bellingham	Washington
United States	GSK Investigational Site	Beloit	Wisconsin
United States	GSK Investigational Site	Bethlehem	Pennsylvania
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boise	Idaho
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Brandon	Florida
United States	GSK Investigational Site	Bridgeport	Connecticut
United States	GSK Investigational Site	Bridgeport	Connecticut
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Brooklyn	New York
United States	GSK Investigational Site	Browns Mills	New Jersey
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Burien	Washington
United States	GSK Investigational Site	Burlington	North Carolina
United States	GSK Investigational Site	Camp Hill	Pennsylvania
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Chambersburg	Pennsylvania
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Columbia	Missouri
United States	GSK Investigational Site	Columbia	Maryland
United States	GSK Investigational Site	Columbia	Tennessee
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Columbia	Montana
United States	GSK Investigational Site	Concord	North Carolina
United States	GSK Investigational Site	Corpus Christi/Texas	Texas
United States	GSK Investigational Site	Cortlandt Manor	New York
United States	GSK Investigational Site	Cottonwood	Arizona
United States	GSK Investigational Site	Crestview Hill	Kentucky
United States	GSK Investigational Site	Cumming	Georgia
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Daytona Beach	Florida
United States	GSK Investigational Site	Daytona Beach	Florida
United States	GSK Investigational Site	Dearborn	Michigan
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Doylestown	Pennsylvania
United States	GSK Investigational Site	Duluth	Minnesota
United States	GSK Investigational Site	Elizabeth	New Jersey
United States	GSK Investigational Site	Elmer	New Jersey
United States	GSK Investigational Site	Elyria	Ohio
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Everett	Washington
United States	GSK Investigational Site	Fairfield	Ohio
United States	GSK Investigational Site	Fairview Park	Ohio
United States	GSK Investigational Site	Fall River	Massachusetts
United States	GSK Investigational Site	Fleming Island	Florida
United States	GSK Investigational Site	Flint	Michigan
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Smith	Arkansas
United States	GSK Investigational Site	Fort Wayne	Indiana
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Gainesville	Florida
United States	GSK Investigational Site	Galveston	Texas
United States	GSK Investigational Site	Gastonia	North Carolina
United States	GSK Investigational Site	Glendale	California
United States	GSK Investigational Site	Glendale	Arizona
United States	GSK Investigational Site	Golden	Colorado
United States	GSK Investigational Site	Grand Forks	North Dakota
United States	GSK Investigational Site	Grand Island	Nebraska
United States	GSK Investigational Site	Great Falls	Montana
United States	GSK Investigational Site	Greeley	Colorado
United States	GSK Investigational Site	Green Bay	Wisconsin
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Guilford	Connecticut
United States	GSK Investigational Site	Gulf Breeze	Florida
United States	GSK Investigational Site	Haddon Heights	New Jersey
United States	GSK Investigational Site	Hammond	Indiana
United States	GSK Investigational Site	Harker Heights	Texas
United States	GSK Investigational Site	Hartford	Connecticut
United States	GSK Investigational Site	Hershey	Pennsylvania
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntersville	North Carolina
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Inverness	Florida
United States	GSK Investigational Site	Iowa City	Iowa
United States	GSK Investigational Site	Jackson	Tennessee
United States	GSK Investigational Site	Jackson	Tennessee
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville Beach	Florida
United States	GSK Investigational Site	Jenkintown	Pennsylvania
United States	GSK Investigational Site	Jersey Shore	Pennsylvania
United States	GSK Investigational Site	Johnson City	Tennessee
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	Joplin	Missouri
United States	GSK Investigational Site	Jupiter	Florida
United States	GSK Investigational Site	Kalamazoo	Michigan
United States	GSK Investigational Site	Kalispell	Montana
United States	GSK Investigational Site	kansas City	Missouri
United States	GSK Investigational Site	Katy	Texas
United States	GSK Investigational Site	Kingwood	Texas
United States	GSK Investigational Site	Kirkland	Washington
United States	GSK Investigational Site	Kissimmee	Florida
United States	GSK Investigational Site	La Mesa	California
United States	GSK Investigational Site	Lafayette	Louisiana
United States	GSK Investigational Site	Lake Charles	Louisiana
United States	GSK Investigational Site	Lancaster	Pennsylvania
United States	GSK Investigational Site	Landsdale	Pennsylvania
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Leetsdale	Pennsylvania
United States	GSK Investigational Site	Lewiston	Maine
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Linden	New Jersey
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Littleton	Colorado
United States	GSK Investigational Site	Lomita	California
United States	GSK Investigational Site	Lorain	Ohio
United States	GSK Investigational Site	Los Alamitos	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Lynchburg	Virginia
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Mansfield	Ohio
United States	GSK Investigational Site	Marquette	Michigan
United States	GSK Investigational Site	Matthews	North Carolina
United States	GSK Investigational Site	Melrose Park	Illinois
United States	GSK Investigational Site	Middleburg Heights	Ohio
United States	GSK Investigational Site	Midlothian	Virginia
United States	GSK Investigational Site	Midwest City	Oklahoma
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Miramar	Florida
United States	GSK Investigational Site	Mission Hills	California
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Mokena	Illinois
United States	GSK Investigational Site	Monroe	North Carolina
United States	GSK Investigational Site	Muncie	Indiana
United States	GSK Investigational Site	Munster	Indiana
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	North Chicago	Illinois
United States	GSK Investigational Site	Oak Ridge	Tennessee
United States	GSK Investigational Site	Oakbrook Terrace	Ohio
United States	GSK Investigational Site	Oakbrook Terrace	Illinois
United States	GSK Investigational Site	Ocala	Florida
United States	GSK Investigational Site	Oklahoma	Oklahoma
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Palm Beach Gardens	Florida
United States	GSK Investigational Site	Papillion	Nebraska
United States	GSK Investigational Site	Park Ridge	Illinois
United States	GSK Investigational Site	Paterson	New Jersey
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Peoria	Illinois
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Pinehurst	North Carolina
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plantation	Florida
United States	GSK Investigational Site	Pomona	New Jersey
United States	GSK Investigational Site	Pontiac	Michigan
United States	GSK Investigational Site	Port Charlotte	Florida
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Rapid City	South Dakota
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Robbinsdale	Minnesota
United States	GSK Investigational Site	Rock Island	Illinois
United States	GSK Investigational Site	Rocky Mount	North Carolina
United States	GSK Investigational Site	Roseville	California
United States	GSK Investigational Site	Roslyn	New York
United States	GSK Investigational Site	Round Rock	Texas
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Safety Harbor	Florida
United States	GSK Investigational Site	Saint Paul	Minnesota
United States	GSK Investigational Site	Salisbury	Maryland
United States	GSK Investigational Site	Salisbury	North Carolina
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Marcos	Texas
United States	GSK Investigational Site	Sandusky	Ohio
United States	GSK Investigational Site	Sanford	North Carolina
United States	GSK Investigational Site	Santa Ana	California
United States	GSK Investigational Site	Santa Ana	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Sayre	Pennsylvania
United States	GSK Investigational Site	Scarborough	Maine
United States	GSK Investigational Site	Scranton	Pennsylvania
United States	GSK Investigational Site	Sellersville	Pennsylvania
United States	GSK Investigational Site	Sewell	New Jersey
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Somerset	New Jersey
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	St Cloud	Minnesota
United States	GSK Investigational Site	St Louis	Missouri
United States	GSK Investigational Site	St. Petersburg	Florida
United States	GSK Investigational Site	St.Louis	Missouri
United States	GSK Investigational Site	Stockton	California
United States	GSK Investigational Site	Stony Brook	New York
United States	GSK Investigational Site	Sugar Land	Texas
United States	GSK Investigational Site	Summit	New Jersey
United States	GSK Investigational Site	Syracuse	New York
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tallahassee	Florida
United States	GSK Investigational Site	Thousand Oaks	California
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Townson	Maryland
United States	GSK Investigational Site	Towson	Maryland
United States	GSK Investigational Site	Trinity	Florida
United States	GSK Investigational Site	Troy	Michigan
United States	GSK Investigational Site	Troy	New York
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tupelo	Mississippi
United States	GSK Investigational Site	Tyler	Texas
United States	GSK Investigational Site	Valparaiso	Indiana
United States	GSK Investigational Site	Ventura	California
United States	GSK Investigational Site	Vero Beach	Florida
United States	GSK Investigational Site	Victoria	Texas
United States	GSK Investigational Site	Voorhees	New Jersey
United States	GSK Investigational Site	Walla Walla	Washington
United States	GSK Investigational Site	Wausau	Wisconsin
United States	GSK Investigational Site	Wellington	Florida
United States	GSK Investigational Site	West Chester	Pennsylvania
United States	GSK Investigational Site	West Des Moines	Iowa
United States	GSK Investigational Site	West Orange	New Jersey
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Williamsville	New York
United States	GSK Investigational Site	Winchester	Virginia
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Worcester	Massachusetts
United States	GSK Investigational Site	York	Pennsylvania
United States	GSK Investigational Site	Youngstown	Ohio
United States	GSK Investigational Site	Ypsilanti	Michigan
United States	GSK Investigational Site	Zaneville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	The TIMI Study Group

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czech Republic,  Denmark,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the first occurrence of any component of the composite of major coronary events (i.e., Coronary Heart Disease (CHD) death, non-fatal myocardial infarction (MI), or urgent coronary revascularization for myocardial ischemia).		Up to 5 years.
Secondary	The composite measure of Major Adverse Cardiovascular Event (MACE) that includes cardiovascular (CV) death (death due to a cardiovascular cause), non-fatal MI, or non-fatal stroke.		Up to 1400 days.
Secondary	Individual components of MACE (CV death, MI (fatal and non-fatal), stroke (fatal and non-fatal)).		Up to 1400 days.
Secondary	Individual components of major coronary events (CHD death, MI (fatal and non-fatal), urgent coronary revascularization for myocardial ischemia).		Up to 1400 days.
Secondary	Composite measure of total coronary events that incl. first occurrence of CHD death, non-fatal MI, hosp. for unstable angina(UA), or any coronary revasc. proc.(excl. percutaneous coronary intervention(PCI) planned prior to but performed after rand.).		Up to 1400 days.
Secondary	Any coronary revascularization procedures (excluding PCI planned prior to randomization but performed after randomization).		Up to 1400 days.
Secondary	The first occurrence of any component of the composite of all-cause mortality, non-fatal MI, or non-fatal stroke.		Up to 1400 days.
Secondary	The composite of CHD death and non-fatal MI.		Up to 1400 days.
Secondary	All cause mortality.		Up to 1400 days.

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.