Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)

Atherosclerosis Clinical Trial

— CANTOS  

Official title:

A Randomized, Double-blind, Placebo-controlled, Event-driven Trial of Quarterly Subcutaneous Canakinumab in the Prevention of Recurrent Cardiovascular Events Among Stable Post-myocardial Infarction Patients With Elevated hsCRP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327846
• Other study ID #: CACZ885M2301
• Secondary ID: 2010-022970-14
• Status: Completed
• Phase: Phase 3
• Start date: April 11, 2011
• Est. completion date: April 14, 2019

Study information

• Verified date: January 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events.

The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase.

Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS).

Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.

Description:

Sub-study 1 and 2 were terminated prior to data collection from subjects. However, there is an ongoing extension trial where patients are receiving open-drug label.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10066
• Est. completion date: April 14, 2019
• Est. primary completion date: March 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main Study Inclusion Criteria:

• Written informed consent

• Male, or Female of non-child-bearing potential

• Age = 18 years.

• Spontaneous MI at least 30 days before randomization. hsCRP = 2 mg/L

Substudy 1 Inclusion:

• All Inclusion from Main Study

• Acquisition of evaluable baseline MRI images of bilateral carotid arteries by the imaging core laboratory

Substudy 2 Inclusion:

• All inclusion from Main Study

• T2D at baseline per Main protocol criteria and be on a stable anti-hyperglycemic medication for at least 4 weeks prior to the baseline OGTT test

• Willing to have the OGTT assessment started before 10 am

Main Study Exclusion Criteria:

• Pregnant or nursing (lactating) women

• Women of child-bearing potential

• Any of the following concomitant diseases

• Planned coronary revascularization (PCI or CABG)

• Major non-cardiac surgical or endoscopic procedure within past 6 months

• Multi-vessel CABG surgery within the past 3 years

• Symptomatic patients with Class IV heart failure (HF) (New York Heart Association [NYHA].

• Uncontrolled hypertension

• Uncontrolled diabetes

• History or evidence of active tuberculosis (TB) infection Substudy 1 Exclusion

• All Main exclusion

• Patients with prior history of carotid angioplasty, stenting, or carotid atherectomy

• Patients with contraindications to MRI examination (brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body or other implanted body, tattoos, implanted insulin pump, metal shrapnel or bullet)

• Patients prone to claustrophobia or known anxiety disorders

• BMI > 40 kg/m2 Substudy 2 Exclusion

• This sub-study does not have any additional exclusion criteria.

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• Canakinumab

• Placebo

• Standard of care
Standard of care post-MI background therapy includes, but is not limited to, lipid lowering, anti-hypertensive, beta blockers, and anti-platelet therapy as appropriate

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Bahía Blanca	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba
Argentina	Novartis Investigative Site	Caba	Capital Federal
Argentina	Novartis Investigative Site	Caba	Capital Federal
Argentina	Novartis Investigative Site	Cipolletti	Rio Negro
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	Formosa
Argentina	Novartis Investigative Site	Formosa
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Posadas	Misiones
Argentina	Novartis Investigative Site	Quilmes	Buenos Aires
Argentina	Novartis Investigative Site	Quilmes	Buenos Aires
Argentina	Novartis Investigative Site	Ramos Mejia	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Salta
Argentina	Novartis Investigative Site	San Isidro	Buenos Aires
Argentina	Novartis Investigative Site	San Luis
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	San Nicolas	Buenos Aires
Argentina	Novartis Investigative Site	San Salvador de Jujuy	Jujuy
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Santiago del Estero
Argentina	Novartis Investigative Site	Tucuman
Argentina	Novartis Investigative Site	Tucuman	San Miguel De Tucuman
Argentina	Novartis Investigative Site	Zarate	Buenos Aires
Australia	Novartis Investigative Site	Bateman	Western Australia
Australia	Novartis Investigative Site	Bundoora	Victoria
Australia	Novartis Investigative Site	Garran	Australian Capital Territory
Australia	Novartis Investigative Site	Geelong	Victoria
Australia	Novartis Investigative Site	Gosford	New South Wales
Australia	Novartis Investigative Site	Hobart	Tasmania
Australia	Novartis Investigative Site	Joondalup	Western Australia
Australia	Novartis Investigative Site	Kogarah	New South Wales
Australia	Novartis Investigative Site	Liverpool	New South Wales
Australia	Novartis Investigative Site	Milton	Queensland
Australia	Novartis Investigative Site	Perth	Western Australia
Australia	Novartis Investigative Site	Southport	Queensland
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Saint Stefan
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Vienna
Austria	Novartis Investigative Site	Wien
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Bonheiden
Belgium	Novartis Investigative Site	Brasschaat
Belgium	Novartis Investigative Site	Brussel
Belgium	Novartis Investigative Site	De Pinte
Belgium	Novartis Investigative Site	Genk
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Hasselt
Belgium	Novartis Investigative Site	Huy
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Mechelen
Belgium	Novartis Investigative Site	Ottignies
Belgium	Novartis Investigative Site	Tienen
Brazil	Novartis Investigative Site	Belem	PA
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Blumenau	SC
Brazil	Novartis Investigative Site	Brasilia	DF
Brazil	Novartis Investigative Site	Brasilia	DF
Brazil	Novartis Investigative Site	Campinas	SP
Brazil	Novartis Investigative Site	Campinas	SP
Brazil	Novartis Investigative Site	Campinas	SP
Brazil	Novartis Investigative Site	Campo Grande	MS
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Fortaleza	CE
Brazil	Novartis Investigative Site	Goiania	GO
Brazil	Novartis Investigative Site	Goiania	GO
Brazil	Novartis Investigative Site	Passo Fundo	RS
Brazil	Novartis Investigative Site	Pelotas	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	Rio Grande Do Sul
Brazil	Novartis Investigative Site	Recife	PE
Brazil	Novartis Investigative Site	Salvador	BA
Brazil	Novartis Investigative Site	Salvador	BA
Brazil	Novartis Investigative Site	Santo Andre	SP
Brazil	Novartis Investigative Site	Sao Jose do Rio Preto	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	São Paulo	SP
Brazil	Novartis Investigative Site	Tatuí	SP
Brazil	Novartis Investigative Site	Uberlandia	MG
Brazil	Novartis Investigative Site	Uberlandia	Minas Gerais
Brazil	Novartis Investigative Site	Votuporanga	SP
Bulgaria	Novartis Investigative Site	Pazardzhik
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Canada	Novartis Investigative Site	Cambridge	Ontario
Canada	Novartis Investigative Site	Drummondville	Quebec
Canada	Novartis Investigative Site	Etobicoke	Ontario
Canada	Novartis Investigative Site	Gatineau	Quebec
Canada	Novartis Investigative Site	Granby	Quebec
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Joliette	Quebec
Canada	Novartis Investigative Site	Kitchener	Ontario
Canada	Novartis Investigative Site	Lachine	Quebec
Canada	Novartis Investigative Site	Laval	Quebec
Canada	Novartis Investigative Site	Levis	Quebec
Canada	Novartis Investigative Site	Longueuil	Quebec
Canada	Novartis Investigative Site	Mississauga	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Mount Pearl	Newfoundland and Labrador
Canada	Novartis Investigative Site	New Westminster	British Columbia
Canada	Novartis Investigative Site	Newmarket	Ontario
Canada	Novartis Investigative Site	Newmarket	Ontario
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Peterborough	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Sainte Foy	Quebec
Canada	Novartis Investigative Site	Saskatoon	Saskatchewan
Canada	Novartis Investigative Site	Scarborough	Ontario
Canada	Novartis Investigative Site	Sherbrooke	Quebec
Canada	Novartis Investigative Site	St-Jean-sur-Richelieu	Quebec
Canada	Novartis Investigative Site	Ste-Foy	Quebec
Canada	Novartis Investigative Site	Surrey	British Columbia
Canada	Novartis Investigative Site	Terrebonne	Quebec
Canada	Novartis Investigative Site	Thetford Mines	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Victoria	British Columbia
Canada	Novartis Investigative Site	Winnipeg	Manitoba
China	Novartis Investigative Site	Baotou	Inner Mongolia
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Changchun	Jilin
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Chongqing	Chongqing
China	Novartis Investigative Site	Fuzhou	Fujian
China	Novartis Investigative Site	Guang Zhou	Guangdong
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Harbin	Heilongjiang
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanning	Guangxi
China	Novartis Investigative Site	Shanghai	Shanghai
China	Novartis Investigative Site	Shanghai	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai City	Shanghai
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Shijiazhuang	Hebei
China	Novartis Investigative Site	Suzhou	Jiangsu
China	Novartis Investigative Site	Tianjin	Tianjin
China	Novartis Investigative Site	Tianjin
China	Novartis Investigative Site	Tianjin
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Xian	Shanxi
China	Novartis Investigative Site	Xian	Shanxi
Colombia	Novartis Investigative Site	Armenia
Colombia	Novartis Investigative Site	Baranquilla
Colombia	Novartis Investigative Site	Baranquilla	Atlantico
Colombia	Novartis Investigative Site	Barranquilla	Atlantico
Colombia	Novartis Investigative Site	Barranquilla
Colombia	Novartis Investigative Site	Barranquilla
Colombia	Novartis Investigative Site	Bogota
Colombia	Novartis Investigative Site	Bogotá
Colombia	Novartis Investigative Site	Bucaramanga	Santander
Colombia	Novartis Investigative Site	Cali
Colombia	Novartis Investigative Site	Cartagena	Bolivar
Colombia	Novartis Investigative Site	Cartegena
Colombia	Novartis Investigative Site	Florida Blanca
Colombia	Novartis Investigative Site	Floridablanca	Santander
Colombia	Novartis Investigative Site	Manizales	Caldas
Croatia	Novartis Investigative Site	Cakovec
Croatia	Novartis Investigative Site	Koprivnica
Croatia	Novartis Investigative Site	Krapinske toplice
Croatia	Novartis Investigative Site	Krapinske Toplice
Croatia	Novartis Investigative Site	Opatija
Croatia	Novartis Investigative Site	Rijeka
Croatia	Novartis Investigative Site	Varazdin	HRV
Croatia	Novartis Investigative Site	Virovitica
Croatia	Novartis Investigative Site	Zagreb
Czechia	Novartis Investigative Site	Benesov
Czechia	Novartis Investigative Site	Brandys nad Labem	Czech Republic
Czechia	Novartis Investigative Site	Brno Bohunice
Czechia	Novartis Investigative Site	Broumov
Czechia	Novartis Investigative Site	Jablonec nad Nisou	Czech Republic
Czechia	Novartis Investigative Site	Kladno	Czech Republic
Czechia	Novartis Investigative Site	Kolin
Czechia	Novartis Investigative Site	Liberec	Czech Republic
Czechia	Novartis Investigative Site	Louny	Czech Republic
Czechia	Novartis Investigative Site	Marianske lazne
Czechia	Novartis Investigative Site	Most	CZE
Czechia	Novartis Investigative Site	Ostrava	Czech Republic
Czechia	Novartis Investigative Site	Pardubice
Czechia	Novartis Investigative Site	Plzen	Czech Republic
Czechia	Novartis Investigative Site	Prague 4 - Krc
Czechia	Novartis Investigative Site	Praha
Czechia	Novartis Investigative Site	Praha 11	Czech Republic
Czechia	Novartis Investigative Site	Praha 2	CZE
Czechia	Novartis Investigative Site	Praha 9	Czech Republic
Czechia	Novartis Investigative Site	Roznov pod Radhostem	Czech Republic
Czechia	Novartis Investigative Site	Semily	Czech Republic
Czechia	Novartis Investigative Site	Slany
Czechia	Novartis Investigative Site	Svitavy	Czech Republic
Czechia	Novartis Investigative Site	Teplice
Czechia	Novartis Investigative Site	Trebic	Czech Republic
Czechia	Novartis Investigative Site	Trutnov	CZE
Czechia	Novartis Investigative Site	Uherske Hradiste
Czechia	Novartis Investigative Site	Usti nad Labem	Czech Republic
Czechia	Novartis Investigative Site	Usti nad Orlici	Czech Republic
Czechia	Novartis Investigative Site	Vyskov	Czech Republic
Czechia	Novartis Investigative Site	Znojmo	Czech Republic
Estonia	Novartis Investigative Site	Parnu
Estonia	Novartis Investigative Site	Saku
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Estonia	Novartis Investigative Site	Viljandi County
Estonia	Novartis Investigative Site	Võru
Germany	Novartis Investigative Site	Bad Krozingen
Germany	Novartis Investigative Site	Balve
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Borna
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Dillingen
Germany	Novartis Investigative Site	Dinslaken
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Duisburg
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Ebersbach
Germany	Novartis Investigative Site	Elsterwerda
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Falkensee
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt am Main
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Fulda
Germany	Novartis Investigative Site	Giengen
Germany	Novartis Investigative Site	Goerlitz
Germany	Novartis Investigative Site	Haag
Germany	Novartis Investigative Site	Halle Saale
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Heilbronn
Germany	Novartis Investigative Site	Huy / OT Anderbeck
Germany	Novartis Investigative Site	Jerichow
Germany	Novartis Investigative Site	Kallstadt
Germany	Novartis Investigative Site	Kamp-Lintfort
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Koblenz
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Kuenzing
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Lüneburg
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mayen
Germany	Novartis Investigative Site	Meissen
Germany	Novartis Investigative Site	Meißen
Germany	Novartis Investigative Site	Muehldorf Am Inn
Germany	Novartis Investigative Site	Muehlhausen
Germany	Novartis Investigative Site	Muehlheim An Der Ruhr	NRW
Germany	Novartis Investigative Site	Neuhofen
Germany	Novartis Investigative Site	Neunkirchen
Germany	Novartis Investigative Site	Northeim
Germany	Novartis Investigative Site	Nurnberg
Germany	Novartis Investigative Site	Oelde
Germany	Novartis Investigative Site	Oschatz
Germany	Novartis Investigative Site	Paderborn
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Rednitzhembach
Germany	Novartis Investigative Site	Reinfeld
Germany	Novartis Investigative Site	Rostock
Germany	Novartis Investigative Site	Rüdersdorf
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Wolmirstedt
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Chalkida
Greece	Novartis Investigative Site	Crete Heraklion
Greece	Novartis Investigative Site	Heraklion Crete
Greece	Novartis Investigative Site	Magoula	GR
Greece	Novartis Investigative Site	Patras
Greece	Novartis Investigative Site	Thessaloniki	GR
Greece	Novartis Investigative Site	Thessaloniki	GR
Greece	Novartis Investigative Site	Voula	GR
Guatemala	Novartis Investigative Site	Guatemala
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Csongrad
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Gyula
Hungary	Novartis Investigative Site	Kistarcsa
Hungary	Novartis Investigative Site	Komarom
Hungary	Novartis Investigative Site	Miskolc
Hungary	Novartis Investigative Site	Mosonmagyarovar
Hungary	Novartis Investigative Site	Nyiregyháza
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szekesfehervar
Hungary	Novartis Investigative Site	Szentes
Hungary	Novartis Investigative Site	Zalaegerszeg	Zala
Iceland	Novartis Investigative Site	Kopavogur
Iceland	Novartis Investigative Site	Reykjavik
Iceland	Novartis Investigative Site	Reykjavik
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Ahmedabad
India	Novartis Investigative Site	Bangalore	Karnataka
India	Novartis Investigative Site	Bengaluru	Karnataka
India	Novartis Investigative Site	Bikaner	Rajasthan
India	Novartis Investigative Site	Chennai	Tamil Nadu
India	Novartis Investigative Site	Coimbatore	Tamil Nadu
India	Novartis Investigative Site	Coimbatore	Tamilnadu
India	Novartis Investigative Site	Ghaziabad	Uttar Pradesh
India	Novartis Investigative Site	Guntur	Andhrapradesh
India	Novartis Investigative Site	Hyderabad	Telangana
India	Novartis Investigative Site	Hyderabad	Andhra Pradesh
India	Novartis Investigative Site	Hyderabad	Andhra Pradesh
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Kochi	Kerala
India	Novartis Investigative Site	Lucknow	Uttar Pradesh
India	Novartis Investigative Site	Ludhiana	Punjab
India	Novartis Investigative Site	Ludhiana	Punjab
India	Novartis Investigative Site	Ludhiana	Punjab
India	Novartis Investigative Site	Madurai	Tamil NADU
India	Novartis Investigative Site	Manipal	Karnataka
India	Novartis Investigative Site	Mohali	Punjab
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nampally	Andhra Pradesh
India	Novartis Investigative Site	Nashik	Maharashtra
India	Novartis Investigative Site	Nellore	Andhra Pradesh
India	Novartis Investigative Site	New Delhi	Delhi
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Rajasthan
India	Novartis Investigative Site	Secunderabad	Telangana
India	Novartis Investigative Site	Surat	Gujarat
India	Novartis Investigative Site	Surat	Gujarat
India	Novartis Investigative Site	Tirupati	Andhra Pradesh
India	Novartis Investigative Site	Vadodara	Gujarat
India	Novartis Investigative Site	Varanasi	Uttar Pradesh
India	Novartis Investigative Site	Vijayawada	Andhra Pradesh
India	Novartis Investigative Site	Vijayawada	Andhra Pradesh
India	Novartis Investigative Site	Vishakhapatnam	Andhra Pradesh
Italy	Novartis Investigative Site	Ancona	AN
Italy	Novartis Investigative Site	Bergamo	BG
Italy	Novartis Investigative Site	Brescia	BS
Italy	Novartis Investigative Site	Casorate Primo	PV
Italy	Novartis Investigative Site	Catanzaro	CZ
Italy	Novartis Investigative Site	Chieti	CH
Italy	Novartis Investigative Site	Cona	FE
Italy	Novartis Investigative Site	Cortona	AR
Italy	Novartis Investigative Site	Fermo	AP
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Foggia	FG
Italy	Novartis Investigative Site	Massa	MS
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Monserrato	CA
Italy	Novartis Investigative Site	Montichiari	BS
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Novara
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Palmanova	UD
Italy	Novartis Investigative Site	Parma	PR
Italy	Novartis Investigative Site	Pavia	PV
Italy	Novartis Investigative Site	Piacenza	PC
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Pozzilli	IS
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	San Daniele Del Friuli	UD
Italy	Novartis Investigative Site	Santa Maria Capua Vetere	CE
Italy	Novartis Investigative Site	Sassari	SS
Italy	Novartis Investigative Site	Soriano Calabro	VV
Italy	Novartis Investigative Site	Treviglio	BG
Italy	Novartis Investigative Site	Verona	VR
Italy	Novartis Investigative Site	Veruno
Japan	Novartis Investigative Site	Amagasaki city	Hyogo
Japan	Novartis Investigative Site	Amagasaki-city	Hyogo
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Fuchu-city	Tokyo
Japan	Novartis Investigative Site	Fujioka city	Gunma
Japan	Novartis Investigative Site	Funabashi	Chiba
Japan	Novartis Investigative Site	Hatsukaichi city	Hiroshima
Japan	Novartis Investigative Site	Higashiibaraki-gun	Ibaraki
Japan	Novartis Investigative Site	Hirakata-City	Osaka
Japan	Novartis Investigative Site	Hitachi-city	Ibaraki
Japan	Novartis Investigative Site	Ichinomiya	Aichi
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Kasuga	Fukuoka
Japan	Novartis Investigative Site	Komatsushima-city	Tokushima
Japan	Novartis Investigative Site	Kumamoto City	Kumamoto
Japan	Novartis Investigative Site	Kurume-city	Fukuoka
Japan	Novartis Investigative Site	Kusatsu-city	Shiga
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Matsudo city	Chiba
Japan	Novartis Investigative Site	Matsudo-city	Chiba
Japan	Novartis Investigative Site	Nagano City	Nagano
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nishinomiya	Hyogo
Japan	Novartis Investigative Site	Ogaki-city	Gifu
Japan	Novartis Investigative Site	Onga-gun	Fukuoka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Sakaide-city	Kagawa
Japan	Novartis Investigative Site	Sayama-city	Saitama
Japan	Novartis Investigative Site	Sendai city	Miyagi
Japan	Novartis Investigative Site	Sendai-shi	Miyagi
Japan	Novartis Investigative Site	Seto-city	Aichi
Japan	Novartis Investigative Site	Takamatsu city	Kagawa
Japan	Novartis Investigative Site	Takarazuka-city	Hyogo
Japan	Novartis Investigative Site	Takasaki-city	Gunma
Japan	Novartis Investigative Site	Takatsuki	Osaka
Japan	Novartis Investigative Site	Tokorozawa	Saitama
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yukuhashi	Fukuoka
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Daejeon	Korea
Korea, Republic of	Novartis Investigative Site	Gwangju
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Seocho Gu
Korea, Republic of	Novartis Investigative Site	Suwon	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Uijeongbu-Si	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Wonju	Gangwon-Do
Latvia	Novartis Investigative Site	Daugavpils
Latvia	Novartis Investigative Site	Liepaja	LV
Latvia	Novartis Investigative Site	Riga	LV
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Valmiera
Latvia	Novartis Investigative Site	Ventspils	LV
Lithuania	Novartis Investigative Site	Alytus
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Kaunas	LTU
Lithuania	Novartis Investigative Site	Kedainiai
Lithuania	Novartis Investigative Site	Klaipeda	LTU
Lithuania	Novartis Investigative Site	Panevezys
Lithuania	Novartis Investigative Site	Siauliai
Lithuania	Novartis Investigative Site	Vilnius
Mexico	Novartis Investigative Site	Aguascalientes
Mexico	Novartis Investigative Site	Culiacan	Sinaloa
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Queretaro
Mexico	Novartis Investigative Site	San Luis Potosi
Mexico	Novartis Investigative Site	San Luis Potosi	San Luis Potosí
Netherlands	Novartis Investigative Site	Alkmaar
Netherlands	Novartis Investigative Site	Amersfoort
Netherlands	Novartis Investigative Site	Amstelveen
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Apeldoorn	DZ
Netherlands	Novartis Investigative Site	Breda
Netherlands	Novartis Investigative Site	Deventer
Netherlands	Novartis Investigative Site	Doetinchem
Netherlands	Novartis Investigative Site	Ede
Netherlands	Novartis Investigative Site	Gouda
Netherlands	Novartis Investigative Site	Groningen
Netherlands	Novartis Investigative Site	Haarlem
Netherlands	Novartis Investigative Site	Heerlen
Netherlands	Novartis Investigative Site	Hoorn
Netherlands	Novartis Investigative Site	Leeuwarden
Netherlands	Novartis Investigative Site	Maastricht	AZ
Netherlands	Novartis Investigative Site	Meppel
Netherlands	Novartis Investigative Site	Nijmegen
Netherlands	Novartis Investigative Site	Rotterdam
Netherlands	Novartis Investigative Site	Rotterdam
Netherlands	Novartis Investigative Site	Sneek	The Netherlands
Netherlands	Novartis Investigative Site	Tiel
Netherlands	Novartis Investigative Site	Utrecht
Netherlands	Novartis Investigative Site	Venlo
Norway	Novartis Investigative Site	Alesund
Norway	Novartis Investigative Site	Elverum
Norway	Novartis Investigative Site	Hamar
Norway	Novartis Investigative Site	Harstad
Norway	Novartis Investigative Site	Hønefoss
Norway	Novartis Investigative Site	Lillehammer
Norway	Novartis Investigative Site	Moss
Norway	Novartis Investigative Site	Nesttun
Norway	Novartis Investigative Site	Oslo
Norway	Novartis Investigative Site	Oslo
Norway	Novartis Investigative Site	Sandefjord
Norway	Novartis Investigative Site	Skedsmokorset
Norway	Novartis Investigative Site	Stavanger
Norway	Novartis Investigative Site	Tonsberg
Norway	Novartis Investigative Site	Trondheim
Norway	Novartis Investigative Site	Tynset
Peru	Novartis Investigative Site	Bellavista	Lima
Peru	Novartis Investigative Site	Lima
Peru	Novartis Investigative Site	San Isidro	Lima
Peru	Novartis Investigative Site	San Martin de Porres	Lima
Poland	Novartis Investigative Site	Gdansk
Poland	Novartis Investigative Site	Gdynia
Poland	Novartis Investigative Site	Gdynia
Poland	Novartis Investigative Site	Gdynia
Poland	Novartis Investigative Site	Lublin
Poland	Novartis Investigative Site	Olawa
Poland	Novartis Investigative Site	Ostrow Wielkopolski
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Pulawy
Poland	Novartis Investigative Site	Rumia
Poland	Novartis Investigative Site	Skierniewice
Poland	Novartis Investigative Site	Torun
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wegrow
Poland	Novartis Investigative Site	Wloclawek
Puerto Rico	Novartis Investigative Site	Manati
Puerto Rico	Novartis Investigative Site	Mayaguez
Puerto Rico	Novartis Investigative Site	Ponce
Puerto Rico	Novartis Investigative Site	Ponce
Puerto Rico	Novartis Investigative Site	San Juan
Puerto Rico	Novartis Investigative Site	San Juan
Puerto Rico	Novartis Investigative Site	San Juan
Romania	Novartis Investigative Site	Baia Mare
Romania	Novartis Investigative Site	Braila	ROM
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest	District 1
Romania	Novartis Investigative Site	Bucharest	District 2
Romania	Novartis Investigative Site	Bucuresti	District 4
Romania	Novartis Investigative Site	Bucuresti	District 1
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Cluj Napoca
Romania	Novartis Investigative Site	Cluj Napoca	Jud Cluj
Romania	Novartis Investigative Site	Cluj-Napoca
Romania	Novartis Investigative Site	Constanta	Jud. Constanta
Romania	Novartis Investigative Site	Craiova	Jud. Dolj
Romania	Novartis Investigative Site	Craiova
Romania	Novartis Investigative Site	Iasi	Jud. Iasi
Romania	Novartis Investigative Site	Iasi	Jud Iasi
Romania	Novartis Investigative Site	Oradea	Jud Bihor
Romania	Novartis Investigative Site	Oradea
Romania	Novartis Investigative Site	Pitesti
Romania	Novartis Investigative Site	Pitesti	Arges
Romania	Novartis Investigative Site	Sibiu
Romania	Novartis Investigative Site	Targu Mures
Romania	Novartis Investigative Site	Targu Mures
Romania	Novartis Investigative Site	Targu Mures	Jud Mures
Romania	Novartis Investigative Site	Targu Mures	Mures
Romania	Novartis Investigative Site	Targu-Mures
Romania	Novartis Investigative Site	Tg Mures	Mures
Romania	Novartis Investigative Site	Timisoara	Timis
Romania	Novartis Investigative Site	Timisoara
Romania	Novartis Investigative Site	Timisoara
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Izhevsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Kirov
Russian Federation	Novartis Investigative Site	Kirov
Russian Federation	Novartis Investigative Site	Krasnodar
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Penza
Russian Federation	Novartis Investigative Site	Perm
Russian Federation	Novartis Investigative Site	Perm
Russian Federation	Novartis Investigative Site	Petrozavodsk
Russian Federation	Novartis Investigative Site	Ryazan
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Russian Federation	Novartis Investigative Site	Samara
Russian Federation	Novartis Investigative Site	Samara
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Sestroretsk
Russian Federation	Novartis Investigative Site	Smolensk
Russian Federation	Novartis Investigative Site	St-Petersburg
Russian Federation	Novartis Investigative Site	St-Petersburg
Russian Federation	Novartis Investigative Site	St. Petersburg
Russian Federation	Novartis Investigative Site	St.- Petersburg
Russian Federation	Novartis Investigative Site	St.Petersburg
Russian Federation	Novartis Investigative Site	Syktyvkar
Russian Federation	Novartis Investigative Site	Tomsk
Russian Federation	Novartis Investigative Site	Tyumen
Russian Federation	Novartis Investigative Site	Vladimir
Russian Federation	Novartis Investigative Site	Yaroslavl
Russian Federation	Novartis Investigative Site	Yekaterinburg
Serbia	Novartis Investigative Site	Beograd
Serbia	Novartis Investigative Site	Nis
Serbia	Novartis Investigative Site	Niska Banja
Serbia	Novartis Investigative Site	Sremska Kamenica
Slovakia	Novartis Investigative Site	Banska Bystrica
Slovakia	Novartis Investigative Site	Bardejov
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava	Slovak Republic
Slovakia	Novartis Investigative Site	Brezno	Slovak Republic
Slovakia	Novartis Investigative Site	Dubnica nad Vahom
Slovakia	Novartis Investigative Site	Dunajska Streda
Slovakia	Novartis Investigative Site	Galanta
Slovakia	Novartis Investigative Site	Komarno	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Levice
Slovakia	Novartis Investigative Site	Lucenec
Slovakia	Novartis Investigative Site	Lucenec
Slovakia	Novartis Investigative Site	Martin
Slovakia	Novartis Investigative Site	Nitra
Slovakia	Novartis Investigative Site	Nitra
Slovakia	Novartis Investigative Site	Nove Zamky
Slovakia	Novartis Investigative Site	Nove Zamky
Slovakia	Novartis Investigative Site	Povazska Bystrica	Slovak Republic
Slovakia	Novartis Investigative Site	Presov	Slovak Republic
Slovakia	Novartis Investigative Site	Presov	Slovak Republic
Slovakia	Novartis Investigative Site	Presov
Slovakia	Novartis Investigative Site	Rimavska Sobota	Slovak Republic
Slovakia	Novartis Investigative Site	Svidnik	Slovak Republic
Slovakia	Novartis Investigative Site	Trnava
Slovakia	Novartis Investigative Site	Velky Krtis	Slovak Republic
Slovakia	Novartis Investigative Site	Zilina
Slovenia	Novartis Investigative Site	Celje
Slovenia	Novartis Investigative Site	Golnik
Slovenia	Novartis Investigative Site	Ljubljana
South Africa	Novartis Investigative Site	Alberton
South Africa	Novartis Investigative Site	Bloemfontein
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town	Western Cape
South Africa	Novartis Investigative Site	Centurion
South Africa	Novartis Investigative Site	Durban	Kwa-Zulu Natal
South Africa	Novartis Investigative Site	Johannesburg
South Africa	Novartis Investigative Site	Kempton Park
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Western Cape
Sweden	Novartis Investigative Site	Boras
Sweden	Novartis Investigative Site	Goteborg
Sweden	Novartis Investigative Site	Göteborg	Vastra Gotalands Lan
Sweden	Novartis Investigative Site	Kristianstad
Sweden	Novartis Investigative Site	Luleå
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Malmö
Sweden	Novartis Investigative Site	Molndal
Sweden	Novartis Investigative Site	Östersund
Sweden	Novartis Investigative Site	Skanör
Sweden	Novartis Investigative Site	Skelleftea
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Uddevalla
Sweden	Novartis Investigative Site	Vallingby
Sweden	Novartis Investigative Site	Vasteras
Taiwan	Novartis Investigative Site	Changhua
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Kaohsiung City
Taiwan	Novartis Investigative Site	Taichung	Taiwan ROC
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Tainan
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei	Taiwan, ROC
Taiwan	Novartis Investigative Site	Taoyuan
Taiwan	Novartis Investigative Site	Yilan
Turkey	Novartis Investigative Site	Aydin
Turkey	Novartis Investigative Site	Eskisehir	Meselik
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Kocaeli
Turkey	Novartis Investigative Site	Mersin
Turkey	Novartis Investigative Site	Sivas
United Kingdom	Novartis Investigative Site	Axbridge	Somerset
United Kingdom	Novartis Investigative Site	Barnet
United Kingdom	Novartis Investigative Site	Basingstoke	Hampshire
United Kingdom	Novartis Investigative Site	Berkshire
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Cardiff
United Kingdom	Novartis Investigative Site	Cardiff	Wales
United Kingdom	Novartis Investigative Site	Cheshire
United Kingdom	Novartis Investigative Site	Chesterfield
United Kingdom	Novartis Investigative Site	Chorley
United Kingdom	Novartis Investigative Site	Dundee	Perthshire
United Kingdom	Novartis Investigative Site	Exeter
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Irvine
United Kingdom	Novartis Investigative Site	Leicester
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Newcastle Upon Tyne
United Kingdom	Novartis Investigative Site	Newport
United Kingdom	Novartis Investigative Site	Newport	Isle Of Wight
United Kingdom	Novartis Investigative Site	Norwich
United Kingdom	Novartis Investigative Site	Nottingham
United Kingdom	Novartis Investigative Site	Salford	Manchester
United Kingdom	Novartis Investigative Site	Sheffield
United Kingdom	Novartis Investigative Site	Taunton	Somerset
United Kingdom	Novartis Investigative Site	Whitby	North Yorkshire
United Kingdom	Novartis Investigative Site	Wiltshire
United Kingdom	Novartis Investigative Site	Worcester
United Kingdom	Novartis Investigative Site	York
United States	Novartis Investigative Site	Abington	Pennsylvania
United States	Novartis Investigative Site	Akron	Ohio
United States	Novartis Investigative Site	Albuquerque	New Mexico
United States	Novartis Investigative Site	Allen	Texas
United States	Novartis Investigative Site	Altoona	Pennsylvania
United States	Novartis Investigative Site	Ames	Iowa
United States	Novartis Investigative Site	Anchorage	Alaska
United States	Novartis Investigative Site	Anderson	South Carolina
United States	Novartis Investigative Site	Ann Arbor	Michigan
United States	Novartis Investigative Site	Asheboro	North Carolina
United States	Novartis Investigative Site	Athens	Georgia
United States	Novartis Investigative Site	Athens	Alabama
United States	Novartis Investigative Site	Augusta	Georgia
United States	Novartis Investigative Site	Aurora	Colorado
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Bartlesville	Oklahoma
United States	Novartis Investigative Site	Baton Rouge	Louisiana
United States	Novartis Investigative Site	Baton Rouge	Louisiana
United States	Novartis Investigative Site	Beaumont	Texas
United States	Novartis Investigative Site	Beaumont	Texas
United States	Novartis Investigative Site	Beaver	Pennsylvania
United States	Novartis Investigative Site	Bedford	Texas
United States	Novartis Investigative Site	Beltsville	Maryland
United States	Novartis Investigative Site	Bend	Oregon
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Binghamton	New York
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Bloomington	Minnesota
United States	Novartis Investigative Site	Bountiful	Utah
United States	Novartis Investigative Site	Bridgeville	Pennsylvania
United States	Novartis Investigative Site	Brownsville	Texas
United States	Novartis Investigative Site	Burke	Virginia
United States	Novartis Investigative Site	Burlington	Massachusetts
United States	Novartis Investigative Site	Camden	New Jersey
United States	Novartis Investigative Site	Camp Hill	Pennsylvania
United States	Novartis Investigative Site	Carmichael	California
United States	Novartis Investigative Site	Chandler	Arizona
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Chelsea	Michigan
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Clearwater	Florida
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Coeur d'Alene	Idaho
United States	Novartis Investigative Site	Colorado Springs	Colorado
United States	Novartis Investigative Site	Columbia	South Carolina
United States	Novartis Investigative Site	Columbia	Maryland
United States	Novartis Investigative Site	Columbia	Missouri
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Coral Springs	Florida
United States	Novartis Investigative Site	Covington	Georgia
United States	Novartis Investigative Site	Covington	Louisiana
United States	Novartis Investigative Site	Cumberland	Rhode Island
United States	Novartis Investigative Site	Cumming	Georgia
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Danville	Virginia
United States	Novartis Investigative Site	Davie	Florida
United States	Novartis Investigative Site	Dayton	Ohio
United States	Novartis Investigative Site	Daytona Beach	Florida
United States	Novartis Investigative Site	Decatur	Georgia
United States	Novartis Investigative Site	Decatur	Georgia
United States	Novartis Investigative Site	DeFuniak Springs	Florida
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Doral	Florida
United States	Novartis Investigative Site	Duluth	Minnesota
United States	Novartis Investigative Site	Duluth	Georgia
United States	Novartis Investigative Site	Edina	Minnesota
United States	Novartis Investigative Site	Endwell	New York
United States	Novartis Investigative Site	Erie	Pennsylvania
United States	Novartis Investigative Site	Escondido	California
United States	Novartis Investigative Site	Evansville	Indiana
United States	Novartis Investigative Site	Evansville	Indiana
United States	Novartis Investigative Site	Fairhope	Alabama
United States	Novartis Investigative Site	Fall River	Massachusetts
United States	Novartis Investigative Site	Fargo	North Dakota
United States	Novartis Investigative Site	Fort Mill	South Carolina
United States	Novartis Investigative Site	Freehold	New Jersey
United States	Novartis Investigative Site	Fridley	Minnesota
United States	Novartis Investigative Site	Fullerton	California
United States	Novartis Investigative Site	Germantown	Tennessee
United States	Novartis Investigative Site	Glendale	Arizona
United States	Novartis Investigative Site	Gonzales	Texas
United States	Novartis Investigative Site	Grand Blanc	Michigan
United States	Novartis Investigative Site	Grand Forks	North Dakota
United States	Novartis Investigative Site	Grand Island	Nebraska
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Greenville	North Carolina
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigative Site	Greenville	Texas
United States	Novartis Investigative Site	Greenville	Tennessee
United States	Novartis Investigative Site	Greer	South Carolina
United States	Novartis Investigative Site	Hattiesburg	Mississippi
United States	Novartis Investigative Site	Haverhill	Massachusetts
United States	Novartis Investigative Site	Hershey	Pennsylvania
United States	Novartis Investigative Site	Hialeah	Florida
United States	Novartis Investigative Site	Hickory	North Carolina
United States	Novartis Investigative Site	Hollywood	Florida
United States	Novartis Investigative Site	Hollywood	Florida
United States	Novartis Investigative Site	Honolulu	Hawaii
United States	Novartis Investigative Site	Hopewell	Virginia
United States	Novartis Investigative Site	Hot Springs	Arkansas
United States	Novartis Investigative Site	Houma	Louisiana
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Huntington Beach	California
United States	Novartis Investigative Site	Huntsville	Alabama
United States	Novartis Investigative Site	Irving	Texas
United States	Novartis Investigative Site	Jackson	Tennessee
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Jacksonville Beach	Florida
United States	Novartis Investigative Site	Jerseyville	Illinois
United States	Novartis Investigative Site	Johnson City	Tennessee
United States	Novartis Investigative Site	Jonesboro	Arkansas
United States	Novartis Investigative Site	Jupiter	Florida
United States	Novartis Investigative Site	Kalamazoo	Michigan
United States	Novartis Investigative Site	Kansas City	Kansas
United States	Novartis Investigative Site	Kansas City	Missouri
United States	Novartis Investigative Site	Kew Gardens	New York
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Lafayette	Louisiana
United States	Novartis Investigative Site	Lafayette	Louisiana
United States	Novartis Investigative Site	Lake Jackson	Texas
United States	Novartis Investigative Site	Lancaster	California
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Layton	Utah
United States	Novartis Investigative Site	Leander	Texas
United States	Novartis Investigative Site	Lexington	Kentucky
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Livingston	Texas
United States	Novartis Investigative Site	Lodi	New Jersey
United States	Novartis Investigative Site	Loma Linda	California
United States	Novartis Investigative Site	Loma Linda	California
United States	Novartis Investigative Site	Lombard	Illinois
United States	Novartis Investigative Site	Long Beach	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Los Gatos	California
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Lufkin	Texas
United States	Novartis Investigative Site	Macon	Georgia
United States	Novartis Investigative Site	Madison	Wisconsin
United States	Novartis Investigative Site	Madisonville	Kentucky
United States	Novartis Investigative Site	Mandeville	Louisiana
United States	Novartis Investigative Site	Marion	Ohio
United States	Novartis Investigative Site	Marshall	Texas
United States	Novartis Investigative Site	McAllen	Texas
United States	Novartis Investigative Site	McKinney	Texas
United States	Novartis Investigative Site	Melrose Park	Illinois
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Metairie	Louisiana
United States	Novartis Investigative Site	Metairie	Louisiana
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami Beach	Florida
United States	Novartis Investigative Site	Midland	Michigan
United States	Novartis Investigative Site	Minden	Louisiana
United States	Novartis Investigative Site	Mineola	New York
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Mission Viejo	California
* Note: There are 1133 locations in all - only the first 1000 are shown.

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Croatia,  Czechia,  Estonia,  Germany,  Greece,  Guatemala,  Hungary,  Iceland,  India,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  Norway,  Peru,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  South Africa,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components	Time to occurrence of CEC (Cardiovascular clinical events adjudication committee) confirmed MACE, which was a composite endpoint consisting of CEC confirmed CV death, CEC confirmed non-fatal MI,or CEC confirmed non-fatal stroke. Patients with the CEC adjudicated reason for death of "Unknown" were counted as CV (cardiovascular) death.	From randomization, to end of treatment plus 30 days, up to approximately 6 years
Primary	Substudy 1 (Core Phase): Change From Baseline in Carotid Plaque Burden in the Bifurcation Region of the Index Carotid Artery		24 months
Primary	Substudy 2 (Core Phase): Change From Baseline of the Insulin Secretion Rate (ISR) Relative to Glucose 0-30 Min Defined as F30 = AUCISR 0-30 / AUCGluc 0-30 Averaged Across the Year 3, 4, 5 Visits		From randomization up to approximately 6 years
Secondary	Patients With Core Phase CEC Confirmed CV Death, Non-fatal MI, Non-fatal Stroke, or Hospitalization for Unstable Angina Requiring Unplanned Revascularization	Occurrence of the composite cardiovascular endpoint consisting of cardiovascular death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina requiring unplanned revascularization.; MACE includes CV death, non-fatal MI and non-fatal stroke. CEC = Clinical Endpoints Committee	From randomization, to end of treatment pus 30 days, up to approximately 6 years
Secondary	Patients With Core Phase New Onset Type 2 Diabetes Among Patients With Pre-diabetes at Randomization	Time to CEC confirmed new onset of type 2 diabetes among those with pre-diabetes at randomization (i.e. excluding those that are normoglycemic at baseline)	From randomization up to approximately 6 years
Secondary	Core Phase All-cause Mortality, Non-fatal MI, or Non-fatal Stroke	Occurrence of the composite endpoint consisting of all-cause mortality, non-fatal IM, or non-fatal stroke	From randomization, to end of treatment plus 30 days, up to approximately 6 years
Secondary	Core Phase All-cause Mortality	Number of participant deaths	From randomization, to end of treatment plus 30 days, up to approximately 6 years
Secondary	Summary of Adverse Events (Core Phase)	Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the double-blind Core phase of the study. AEs/SAEs are any signs or symptoms that occur during the study treatment.	From randomization, to end of treatment plus 30 days, up to approximately 6 years
Secondary	Summary of Adverse Events (Extension Phase)	Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the Extension phase of the study. AEs/SAEs are any signs or symptoms that occur during the study treatment.	From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years
Secondary	Substudy 1 (Core Phase): Change From Baseline of the Total Vessel Wall Area at Month 3 in the Bifurcation Region of the Index Carotid Artery		3 months
Secondary	Substudy 1 (Core Phase): Mean Total Vessel Wall Area Across the Left and Right Carotid Artery at Month 3 and Month 24		24 months
Secondary	Substudy 1 (Core Phase): Change From Baseline in Corresponding Total Vessel Wall Area in the Left and Right Carotid Arteries		24 months
Secondary	Substudy 1 (Core Phase): The Existence of a Baseline Total Vessel Wall Area by Treatment Interaction as Well as the Consistency of the Treatment Effect Across Subgroups		24 months
Secondary	Substudy 2 (Core Phase): Change From Baseline in Insulin Sensitivity Index		From randomization up to approximately 6 years
Secondary	Substudy 2 (Core Phase): Change From Baseline in OGTT Stimulated Area Under Curve (AUC) 0-120 Min of Glucose Concentration, Insulin Concentration, Pro-insulin Concentration, and Insulin Concentration/Glucose Concentration Ratio		From randomization up to approximately 6 years
Secondary	Substudy 2 (Core Phase): Change From Baseline in Fasting Pro-Insulin Concentration/Insulin Concentration Ratio		From randomization up to approximately 6 years
Secondary	Substudy 2 (Core Phase): Change From Baseline in OGTT Stimulated Area Under the Curve (AUC) 0-120 Min of C-peptide Concentration		From randomization up to approximately 6 years