The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial

Atherosclerosis Clinical Trial

— STABILITY  

Official title:

LPL100601, A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799903
• Other study ID #: 100601
• Status: Completed
• Phase: Phase 3
• First received: November 26, 2008
• Last updated: March 21, 2017
• Start date: December 2008
• Est. completion date: October 2013

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 stroke) in people with coronary heart disease.

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, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15828
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.

• Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.

• Chronic coronary heart disease

• At least one of the following:

• At least 60 years old

• Diabetes requiring treatment with medication

• Low HDL cholesterol ("good cholesterol")

• Currently smoke cigarettes or stopped smoking within the past 3 months

• 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 arterial disease.

Exclusion Criteria:

• Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.

• 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 expected to result in death within the next 2 years (other than heart disease)

• Severe asthma that is poorly controlled with medication

• Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)

• Previous severe allergic response to food, drink, insect stings, etc.

• Drug or alcohol abuse within the past 6 months OR 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)

• Participation in a study of an investigational medication within the past 30 days

• Current participation in a study of an investigational device

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Darapladib
Lp-PLA2 inhibitor administered in addition to standard therapy
• Placebo
Placebo administered in addition to standard therapy

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Adrogue	Buenos Aires
Argentina	GSK Investigational Site	Bahia Blanca	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Caba	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	Corrientes
Argentina	GSK Investigational Site	Corrientes
Argentina	GSK Investigational Site	Junin	Buenos Aires
Argentina	GSK Investigational Site	La Plata	Buenos Aires
Argentina	GSK Investigational Site	Mar del Plata	Buenos Aires
Argentina	GSK Investigational Site	Mendoza
Argentina	GSK Investigational Site	Ramos Mejia	Buenos Aires
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Santa Fe
Argentina	GSK Investigational Site	Tucuman
Australia	GSK Investigational Site	Auchenflower	Queensland
Australia	GSK Investigational Site	Ballarat	Victoria
Australia	GSK Investigational Site	Bedford Park	South Australia
Australia	GSK Investigational Site	Caulfield South	Victoria
Australia	GSK Investigational Site	Coffs Harbour	New South Wales
Australia	GSK Investigational Site	Concord	New South Wales
Australia	GSK Investigational Site	Frankston	Victoria
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	Joondalup	Western Australia
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	GSK Investigational Site	Liverpool	New South Wales
Australia	GSK Investigational Site	Malvern	Victoria
Australia	GSK Investigational Site	Nedlands	Western Australia
Australia	GSK Investigational Site	Sherwood	Queensland
Belgium	GSK Investigational Site	Aalst
Belgium	GSK Investigational Site	Antwerpen
Belgium	GSK Investigational Site	Bonheiden
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Genk
Belgium	GSK Investigational Site	Hasselt
Belgium	GSK Investigational Site	La Louvière
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Liège
Belgium	GSK Investigational Site	Roeselaere
Belgium	GSK Investigational Site	Yvoir
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais
Brazil	GSK Investigational Site	Campinas	São Paulo
Brazil	GSK Investigational Site	Curitiba	Paraná
Brazil	GSK Investigational Site	Goiânia	Goiás
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	Rio de Janeiro
Brazil	GSK Investigational Site	Salvador	Bahía
Brazil	GSK Investigational Site	São José do Rio Preto	São Paulo
Brazil	GSK Investigational Site	São José do Rio Preto	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
Bulgaria	GSK Investigational Site	Dimitrovgrad
Bulgaria	GSK Investigational Site	Pleven
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Ruse
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	Bay Roberts	Newfoundland and Labrador
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Gatineau	Quebec
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Kelowna	British Columbia
Canada	GSK Investigational Site	Kitchener	Ontario
Canada	GSK Investigational Site	Levis	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	New Westminster	British Columbia
Canada	GSK Investigational Site	Oshawa	Ontario
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Quebec City	Quebec
Canada	GSK Investigational Site	Quebec City	Quebec
Canada	GSK Investigational Site	Saint Charles-Borromee	Quebec
Canada	GSK Investigational Site	Scarborough	Ontario
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	St. John's	Newfoundland and Labrador
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Thornhill	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Trois Rivières	Quebec
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
Canada	GSK Investigational Site	Winnipeg	Manitoba
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	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	Talcahuano	Región Del Biobio
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	Guangzhou
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Haerbin
China	GSK Investigational Site	Hang Zhou	Zhejiang
China	GSK Investigational Site	Jinan	Shandong
China	GSK Investigational Site	Nanjing	Jiangsu
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Wuhan
China	GSK Investigational Site	Xian	Shaanxi
Czech Republic	GSK Investigational Site	Caslav
Czech Republic	GSK Investigational Site	Chomutov
Czech Republic	GSK Investigational Site	Chrudim
Czech Republic	GSK Investigational Site	Jihlava
Czech Republic	GSK Investigational Site	Kladno
Czech Republic	GSK Investigational Site	Kolin
Czech Republic	GSK Investigational Site	Kromeriz
Czech Republic	GSK Investigational Site	Milevsko
Czech Republic	GSK Investigational Site	Pisek
Czech Republic	GSK Investigational Site	Praha 2
Czech Republic	GSK Investigational Site	Pribram
Czech Republic	GSK Investigational Site	Slany
Czech Republic	GSK Investigational Site	Svitavy
Czech Republic	GSK Investigational Site	Tabor
Czech Republic	GSK Investigational Site	Usti nad Orlici
Denmark	GSK Investigational Site	Aarhus
Denmark	GSK Investigational Site	Esbjerg
Denmark	GSK Investigational Site	Koebenhavn OE
Denmark	GSK Investigational Site	Silkeborg
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
France	GSK Investigational Site	Aix en Provence cedex 1
France	GSK Investigational Site	Avignon
France	GSK Investigational Site	Besançon Cedex
France	GSK Investigational Site	Bron Cedex
France	GSK Investigational Site	Créteil
France	GSK Investigational Site	Dijon
France	GSK Investigational Site	Lille Cedex
France	GSK Investigational Site	Marseille cedex 5
France	GSK Investigational Site	Metz Cedex 03
France	GSK Investigational Site	Nantes Cedex 1
France	GSK Investigational Site	Narbonne Cedex
France	GSK Investigational Site	Nimes
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris Cedex 13
France	GSK Investigational Site	Paris Cedex 18
France	GSK Investigational Site	Pessac cedex
France	GSK Investigational Site	Roubaix
France	GSK Investigational Site	Strasbourg cedex
France	GSK Investigational Site	Toulouse Cedex 09
France	GSK Investigational Site	Tourcoing
Germany	GSK Investigational Site	Aschaffenburg	Bayern
Germany	GSK Investigational Site	Bad Oeynhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bernau	Brandenburg
Germany	GSK Investigational Site	Deggingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Delitzsch	Sachsen
Germany	GSK Investigational Site	Dorsten	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Eschweiler	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt/M.	Hessen
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Gueglingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Haag	Bayern
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Herford	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hoehenkirchen-Siegertsbrunn	Bayern
Germany	GSK Investigational Site	Kelkheim	Hessen
Germany	GSK Investigational Site	Kuenzing	Bayern
Germany	GSK Investigational Site	Leipzg	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Lienen-Kattenvenne	Nordrhein-Westfalen
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Muehldorf	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Rhaunen	Rheinland-Pfalz
Germany	GSK Investigational Site	Schmiedeberg	Sachsen
Germany	GSK Investigational Site	Sulzbach-Rosenberg	Bayern
Germany	GSK Investigational Site	Ulm	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wallerfing	Bayern
Germany	GSK Investigational Site	Weyhe-Leeste	Niedersachsen
Germany	GSK Investigational Site	Witten	Nordrhein-Westfalen
Greece	GSK Investigational Site	Agia Varvara, Athens
Greece	GSK Investigational Site	Alexandroupolis
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Chalkida
Greece	GSK Investigational Site	Ioannina
Greece	GSK Investigational Site	Magoula, Elefsina
Greece	GSK Investigational Site	Patras
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Voula / Athens
Hong Kong	GSK Investigational Site	Hong Kong
Hong Kong	GSK Investigational Site	Shatin, New Territories
Hungary	GSK Investigational Site	Berettyóújfalu
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Esztergom
Hungary	GSK Investigational Site	Gyula
Hungary	GSK Investigational Site	Komárom
Hungary	GSK Investigational Site	Mosonmagyaróvár
Hungary	GSK Investigational Site	Sátoraljaújhely
Hungary	GSK Investigational Site	Székesfehérvár
Hungary	GSK Investigational Site	Szikszó
Hungary	GSK Investigational Site	Szolnok
India	GSK Investigational Site	Ahmedabad
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Cochin
India	GSK Investigational Site	Jaipur
India	GSK Investigational Site	Jaipur
India	GSK Investigational Site	Mysore
India	GSK Investigational Site	New Delhi
India	GSK Investigational Site	Patiala
India	GSK Investigational Site	Pune
India	GSK Investigational Site	Pune
India	GSK Investigational Site	Saket,Delhi
India	GSK Investigational Site	Vadodara
India	GSK Investigational Site	Vijayawada
Italy	GSK Investigational Site	Ascoli Piceno	Marche
Italy	GSK Investigational Site	Carpi	Emilia-Romagna
Italy	GSK Investigational Site	Chieti	Abruzzo
Italy	GSK Investigational Site	Cona (Ferrara)	Emilia-Romagna
Italy	GSK Investigational Site	Cuneo	Piemonte
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Novara	Piemonte
Italy	GSK Investigational Site	Parma	Emilia-Romagna
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Treviso	Veneto
Japan	GSK Investigational Site	Aichi
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	Kagoshima
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Nagano
Japan	GSK Investigational Site	Nagasaki
Japan	GSK Investigational Site	Nagasaki
Japan	GSK Investigational Site	Oita
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Shiga
Japan	GSK Investigational Site	Shizuoka
Japan	GSK Investigational Site	Tokyo
Korea, Republic of	GSK Investigational Site	Cheongju
Korea, Republic of	GSK Investigational Site	Dae-Gu
Korea, Republic of	GSK Investigational Site	Gangnam-gu, Seoul
Korea, Republic of	GSK Investigational Site	Gwangju
Korea, Republic of	GSK Investigational Site	jeonju-si, Jeollabuk-Do
Korea, Republic of	GSK Investigational Site	Seo-gu Busan
Korea, Republic of	GSK Investigational Site	Seongnam-si Gyeonggi-do
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
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	Uijeongbu-si Kyonggi-do
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Mexico
Mexico	GSK Investigational Site	México D.F,
Mexico	GSK Investigational Site	Monterrey NL	Nuevo León
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Beverwijk
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Doetinchem
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Enschede
Netherlands	GSK Investigational Site	Goes
Netherlands	GSK Investigational Site	Harderwijk
Netherlands	GSK Investigational Site	Hoofddorp
Netherlands	GSK Investigational Site	Leeuwarden
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Sittard-geleen
Netherlands	GSK Investigational Site	Sneek
Netherlands	GSK Investigational Site	Tiel
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Dunedin
New Zealand	GSK Investigational Site	Grafton, Auckland
New Zealand	GSK Investigational Site	Hamilton
New Zealand	GSK Investigational Site	Lower Hutt
New Zealand	GSK Investigational Site	Nelson
New Zealand	GSK Investigational Site	Otahuhu, Auckland
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	Timaru
New Zealand	GSK Investigational Site	Whangarei
Norway	GSK Investigational Site	Bergen
Norway	GSK Investigational Site	Moss
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Oslo
Pakistan	GSK Investigational Site	Karachi
Pakistan	GSK Investigational Site	Karachi
Pakistan	GSK Investigational Site	Korangi / Karachi
Pakistan	GSK Investigational Site	Lahore
Pakistan	GSK Investigational Site	Lahore
Pakistan	GSK Investigational Site	Multan
Pakistan	GSK Investigational Site	Rawalpindi Cantt
Peru	GSK Investigational Site	Callao
Peru	GSK Investigational Site	Jesus Maria	Lima
Peru	GSK Investigational Site	Lima
Philippines	GSK Investigational Site	Ermita, Manila
Philippines	GSK Investigational Site	Manila
Philippines	GSK Investigational Site	Manila
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	San Juan
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Gdynia
Poland	GSK Investigational Site	Kowanowko
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Mielec
Poland	GSK Investigational Site	Ostrow Wielkopolski
Poland	GSK Investigational Site	Plonsk
Poland	GSK Investigational Site	Radom
Poland	GSK Investigational Site	Ruda Slaska
Poland	GSK Investigational Site	Siemianowice Slaskie
Poland	GSK Investigational Site	Skierniewice
Poland	GSK Investigational Site	Torun
Poland	GSK Investigational Site	Tychy
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wloclawek
Poland	GSK Investigational Site	Wroclaw
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	Bucharest
Romania	GSK Investigational Site	Deva
Romania	GSK Investigational Site	Galati
Romania	GSK Investigational Site	Targu Mures
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Kemerovo
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	Novosibirsk
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Ryazan
Russian Federation	GSK Investigational Site	S.-Petresburg
Russian Federation	GSK Investigational Site	St Pertersburg
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	Yekaterinburg
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Nitra
South Africa	GSK Investigational Site	Bellville
South Africa	GSK Investigational Site	Bloemfontein
South Africa	GSK Investigational Site	Kempton Park
South Africa	GSK Investigational Site	Kuils River
South Africa	GSK Investigational Site	Moreletapark
South Africa	GSK Investigational Site	Olivedale
South Africa	GSK Investigational Site	Paarl
South Africa	GSK Investigational Site	Parktown	Gauteng
South Africa	GSK Investigational Site	Parktown West
South Africa	GSK Investigational Site	Parow
South Africa	GSK Investigational Site	Pinelands
South Africa	GSK Investigational Site	Somerset West
South Africa	GSK Investigational Site	Soweto
South Africa	GSK Investigational Site	Umhlanga
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Jerez de la Frontera
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Marid
Spain	GSK Investigational Site	Oviedo
Spain	GSK Investigational Site	Pozuelo de Alarcón/Madrid
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	Santander
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Sta Coloma de Gramanet (Barcelona)
Spain	GSK Investigational Site	Valdemoro/Madrid
Sweden	GSK Investigational Site	Eksjö
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Linköping
Sweden	GSK Investigational Site	Lund
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Östersund
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Umeå
Sweden	GSK Investigational Site	Uppsala
Sweden	GSK Investigational Site	Västerås
Sweden	GSK Investigational Site	Västervik
Taiwan	GSK Investigational Site	Changhua
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Tainan
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei City
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Chiangmai
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	Lviv
Ukraine	GSK Investigational Site	Odesa
Ukraine	GSK Investigational Site	Odesa
Ukraine	GSK Investigational Site	Vinnytsia
Ukraine	GSK Investigational Site	Zaporizhzhia
United Kingdom	GSK Investigational Site	Barnet
United Kingdom	GSK Investigational Site	Cambridge	Cambridgeshire
United Kingdom	GSK Investigational Site	Chelsea	London
United Kingdom	GSK Investigational Site	Chertsey	Surrey
United Kingdom	GSK Investigational Site	Chichester	Sussex West
United Kingdom	GSK Investigational Site	Coatbridge
United Kingdom	GSK Investigational Site	Cottingham
United Kingdom	GSK Investigational Site	Cumbernauld
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Hamilton
United Kingdom	GSK Investigational Site	Harrow	Middlesex
United Kingdom	GSK Investigational Site	Hertfordshire
United Kingdom	GSK Investigational Site	Liverpool
United Kingdom	GSK Investigational Site	Liverpool	Merseyside
United Kingdom	GSK Investigational Site	Motherwell	Lanarkshire
United Kingdom	GSK Investigational Site	Newcastle-upon-Tyne
United Kingdom	GSK Investigational Site	Paisley
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Amarillo	Texas
United States	GSK Investigational Site	Anchorage	Alaska
United States	GSK Investigational Site	Atlantis	Florida
United States	GSK Investigational Site	Auburn	Maine
United States	GSK Investigational Site	Aurora	Illinois
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Avon	Indiana
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bangor	Maine
United States	GSK Investigational Site	Beaver	Pennsylvania
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Bridgeport	Connecticut
United States	GSK Investigational Site	Bridgeport	Connecticut
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Browns Mills	New Jersey
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Burke	Virginia
United States	GSK Investigational Site	Cadillac	Michigan
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	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Colorada Springs	Colorado
United States	GSK Investigational Site	Concord	California
United States	GSK Investigational Site	Conyers	Georgia
United States	GSK Investigational Site	Corpus Christi/Texas	Texas
United States	GSK Investigational Site	Crestview Hills	Kentucky
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Danville	Pennsylvania
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Doylestown	Pennsylvania
United States	GSK Investigational Site	Draper	Utah
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Elizabeth	New Jersey
United States	GSK Investigational Site	Elyria	Ohio
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Franklin	Indiana
United States	GSK Investigational Site	Gainesville	Florida
United States	GSK Investigational Site	Garfield Heights	Ohio
United States	GSK Investigational Site	Gastonia	North Carolina
United States	GSK Investigational Site	Georgetown	Texas
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	Greenfield	Indiana
United States	GSK Investigational Site	Harker Heights	Texas
United States	GSK Investigational Site	Hartford	Connecticut
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	Huntsville	Alabama
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Iowa City	Iowa
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	Jersey Shore	Pennsylvania
United States	GSK Investigational Site	Johnson City	Tennessee
United States	GSK Investigational Site	Kettering	Ohio
United States	GSK Investigational Site	Kirkland	Washington
United States	GSK Investigational Site	Lafayette	Louisiana
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lewistown	Pennsylvania
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Lomita	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	Madera	California
United States	GSK Investigational Site	Matthews	North Carolina
United States	GSK Investigational Site	Melrose Park	Illinois
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Middleburg Heights	Ohio
United States	GSK Investigational Site	Natick	Massachusetts
United States	GSK Investigational Site	New Iberia	Louisiana
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	Newark	Delaware
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Oakland	California
United States	GSK Investigational Site	Oakland	California
United States	GSK Investigational Site	Ocala	Florida
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Olympia	Washington
United States	GSK Investigational Site	Oxon Hill	Maryland
United States	GSK Investigational Site	Petoskey	Michigan
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philipsburg	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Ponte Verda	Florida
United States	GSK Investigational Site	Port Matilda	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Poway	California
United States	GSK Investigational Site	Prince Frederick	Maryland
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Rapid City	South Dakota
United States	GSK Investigational Site	Renton	Washington
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Salisbury	North Carolina
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Ramon	California
United States	GSK Investigational Site	Sandusky	Ohio
United States	GSK Investigational Site	Santa Ana	California
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	Scranton	Pennsylvania
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Sellersville	Pennsylvania
United States	GSK Investigational Site	Sioux Falls	South Dakota
United States	GSK Investigational Site	Slidell	Louisiana
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Spring Valley	California
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	St Louis	Missouri
United States	GSK Investigational Site	St. Cloud	Minnesota
United States	GSK Investigational Site	Statesville	North Carolina
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Thornton	Colorado
United States	GSK Investigational Site	Thousand Oaks	California
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Valparaiso	Indiana
United States	GSK Investigational Site	Victoria	Texas
United States	GSK Investigational Site	Walla Walla	Washington
United States	GSK Investigational Site	Wausau	Wisconsin
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	West Des Moines	Iowa
United States	GSK Investigational Site	West Orange	New Jersey
United States	GSK Investigational Site	Westfield	New York
United States	GSK Investigational Site	Westlake	Ohio
United States	GSK Investigational Site	Wilkes-Barre	Pennsylvania
United States	GSK Investigational Site	Williamsville	New York
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Winchester	Virginia
United States	GSK Investigational Site	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Czech Republic,  Denmark,  Estonia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Pakistan,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  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 Adverse Cardiovascular Events [MACE: CV death (death due to a cardiovasacular cause), non-fatal myocardial infarction, non-fatal stroke]		Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years.
Secondary	The composite measure of major coronary events that include the time to first occurrence of coronary heart disease death, non-fatal myocardial infarction or urgent coronary revascularization for myocardial ischemia		Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years.
Secondary	The composite measure of total coronary events that include the time to first occurrence of coronary heart disease death, non-fatal myocardial infarction, hospitalization for unstable angina , or any coronary revascularization procedure		Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years.
Secondary	The time to individual components of MACE [cardiovascular death, myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal) ]		Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years.
Secondary	The time to the first occurrence of any component of the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke		Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years.
Secondary	All cause mortality		Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years.

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.