Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

Acute Coronary Syndrome Clinical Trial

— ELIXA  

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147250
• Other study ID #: EFC11319
• Secondary ID: 2009-012852-26U1
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2010
• Last updated: February 16, 2016
• Start date: June 2010
• Est. completion date: February 2015

Study information

• Verified date: February 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

• To demonstrate that lixisenatide can reduce cardiovascular morbidity and mortality [composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina] compared to placebo in type 2 diabetic patients who recently experienced an acute coronary syndrome (ACS) event.

Secondary Objectives:

To demonstrate that when compared to placebo, lixisenatide can reduce:

• composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure

• composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure

• urinary albumin excretion (based on the urinary albumin/creatinine ratio).

To assess the safety and tolerability of lixisenatide.

Description:

The estimated maximum study duration for the first randomized patient will be approximately 204 weeks (± 14 days), with a median follow-up over all patients of approximately 91 weeks, broken down as follows:

• placebo-run-in period: 7 days (+ 3 days)

• double-blind study treatment period: 203 weeks (± 14 days) (with about a 37 months of recruitment period)

• post-treatment follow-up period: 3 days (± 1 day)

All patients will be followed from randomization until the end of study, which should occur when the last randomized patient has been followed for approximately 10 months. The actual end date of the study will be "event driven"and the study will end when there are approximately 844 positively-adjudicated primary cardiovascular outcome events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6076
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion criteria:

• Men and women who experienced a spontaneous acute coronary syndrome (ACS) event [i.e., ST-segment elevation myocardial infarction (STEMI)] or non-ST-segment elevation myocardial infarction (NSTEMI) or unstable angina (USA)] with a documented elevation above the normal reference range of a cardiac biomarker (Troponin or Creatinine Kinase (CK)-MB) and the clinical presentation consistent with an acute coronary syndrome which leads to admission to an acute care facility, within 180 days following the ACS event and prior to screening.

• Patients with a history of type 2 diabetes (for patients newly diagnosed, diagnosis will be based on the World Health Organization (WHO) criteria: i.e., either a fasting venous plasma glucose concentration = 7.0 mmol/L [126 mg/dL] or 2-hour post glucose load venous plasma glucose = 11.1 mmol/L [200 mg/dL], confirmed on 2 occasions) prior to the screening visit.

Exclusion criteria:

• Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to screening.

• HbA1c <5.5 % or >11% measured at screening visit.

• Required to use incretin-based agents (eg, Glucagon-like peptide -1(GLP-1) agonists or Dipeptidyl Peptidase-4 (DPP-4) inhibitors) other than the study drug during the doubleblind treatment period.

• Patients who have undergone CABG surgery following the qualifying ACS event.

• Patients who have undergone PCI within 15 days prior to screening.

• Patients with planned revascularization procedure (PCI or CABG) or coronary angiogram within 90 days after screening visit.

• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC), or genetic conditions that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).

• Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• lixisenatide (AVE0010)
Pharmaceutical form:sterile aqueous solution Route of administration: subcutaneous
• placebo
Pharmaceutical form:sterile aqueous solution Route of administration: subcutaneous

Locations

Country	Name	City	State
Argentina	Investigational Site Number 032028	Adrogue
Argentina	Investigational Site Number 032030	Bahia Blanca
Argentina	Investigational Site Number 032043	Bahia Blanca
Argentina	Investigational Site Number 032054	Bahia Blanca
Argentina	Investigational Site Number 032003	Caba
Argentina	Investigational Site Number 032049	Caba
Argentina	Investigational Site Number 032056	Caba
Argentina	Investigational Site Number 032066	Caba
Argentina	Investigational Site Number 032009	Capital Federal
Argentina	Investigational Site Number 032017	Capital Federal
Argentina	Investigational Site Number 032050	Cipolletti
Argentina	Investigational Site Number 032052	Ciudad Autonoma De Bs.As
Argentina	Investigational Site Number 032011	Cordoba
Argentina	Investigational Site Number 032022	Cordoba
Argentina	Investigational Site Number 032037	Cordoba
Argentina	Investigational Site Number 032015	Córdoba
Argentina	Investigational Site Number 032020	Coronel Suarez
Argentina	Investigational Site Number 032004	Corrientes
Argentina	Investigational Site Number 032018	Corrientes
Argentina	Investigational Site Number 032005	Godoy Cruz
Argentina	Investigational Site Number 032042	Haedo
Argentina	Investigational Site Number 032019	Junin
Argentina	Investigational Site Number 032063	La Plata
Argentina	Investigational Site Number 032040	Lanus
Argentina	Investigational Site Number 032036	Mar Del Plata
Argentina	Investigational Site Number 032039	Mar Del Plata
Argentina	Investigational Site Number 032058	Mendoza
Argentina	Investigational Site Number 032038	Moron
Argentina	Investigational Site Number 032002	Parana
Argentina	Investigational Site Number 032023	Qilmes
Argentina	Investigational Site Number 032047	Rafaela
Argentina	Investigational Site Number 032024	Ramos Mejia
Argentina	Investigational Site Number 032006	Resistencia
Argentina	Investigational Site Number 032012	Rosario
Argentina	Investigational Site Number 032027	Rosario
Argentina	Investigational Site Number 032055	Salta
Argentina	Investigational Site Number 032065	Salta
Argentina	Investigational Site Number 032008	San Miguel De Tucuman
Argentina	Investigational Site Number 032051	San Miguel De Tucuman
Argentina	Investigational Site Number 032033	San Nicolas
Argentina	Investigational Site Number 032035	Santa Fe
Argentina	Investigational Site Number 032045	Santa Fe
Argentina	Investigational Site Number 032062	Santa Rosa
Argentina	Investigational Site Number 032034	Venado Tuerto
Argentina	Investigational Site Number 032046	Villa Maria
Argentina	Investigational Site Number 032029	Zarate
Australia	Investigational Site Number 036015	Epping
Australia	Investigational Site Number 036001	Fremantle
Australia	Investigational Site Number 036009	Geelong
Australia	Investigational Site Number 036011	Perth
Australia	Investigational Site Number 036005	St Leonards
Australia	Investigational Site Number 036016	Townsville
Austria	Investigational Site Number 040002	Graz
Austria	Investigational Site Number 040001	Wien
Belarus	Investigational Site Number 112001	Minsk
Belarus	Investigational Site Number 112002	Minsk
Belarus	Investigational Site Number 112003	Minsk
Belgium	Investigational Site Number 056001	Bruxelles
Belgium	Investigational Site Number 056003	Leuven
Brazil	Investigational Site Number 076024	Belem
Brazil	Investigational Site Number 076006	Belo Horizonte
Brazil	Investigational Site Number 076012	Belo Horizonte
Brazil	Investigational Site Number 076021	Brasilia
Brazil	Investigational Site Number 076002	Campinas
Brazil	Investigational Site Number 076019	Curitiba
Brazil	Investigational Site Number 076003	Fortaleza
Brazil	Investigational Site Number 076004	Fortaleza
Brazil	Investigational Site Number 076018	Fortaleza
Brazil	Investigational Site Number 076023	Goiania
Brazil	Investigational Site Number 076014	Marilia
Brazil	Investigational Site Number 076015	Passo Fundo
Brazil	Investigational Site Number 076008	Porto Alegre
Brazil	Investigational Site Number 076013	Porto Alegre
Brazil	Investigational Site Number 076026	Porto Alegre
Brazil	Investigational Site Number 076025	Recife
Brazil	Investigational Site Number 076020	Salvador
Brazil	Investigational Site Number 076001	Sao Paulo
Brazil	Investigational Site Number 076005	Sao Paulo
Brazil	Investigational Site Number 076010	Sao Paulo
Brazil	Investigational Site Number 076016	Sao Paulo
Brazil	Investigational Site Number 076007	Uberlandia
Bulgaria	Investigational Site Number 100002	Byala
Bulgaria	Investigational Site Number 100011	Gabrovo
Bulgaria	Investigational Site Number 100001	Kazanluk
Bulgaria	Investigational Site Number 100006	Lovech
Bulgaria	Investigational Site Number 100004	Pleven
Bulgaria	Investigational Site Number 100003	Plovdiv
Bulgaria	Investigational Site Number 100007	Plovdiv
Bulgaria	Investigational Site Number 100016	Sandanski
Bulgaria	Investigational Site Number 100010	Sofia
Bulgaria	Investigational Site Number 100015	Sofia
Bulgaria	Investigational Site Number 100005	Varna
Canada	Investigational Site Number 124024	Calgary
Canada	Investigational Site Number 124016	Cambridge
Canada	Investigational Site Number 124026	Edmonton
Canada	Investigational Site Number 124001	Laval
Canada	Investigational Site Number 124006	Montreal
Canada	Investigational Site Number 124021	Montreal
Canada	Investigational Site Number 124027	Oshawa
Canada	Investigational Site Number 124025	Quebec
Canada	Investigational Site Number 124028	Red Deer
Canada	Investigational Site Number 124007	Sarnia
Canada	Investigational Site Number 124003	St-Marc-Des-Carrieres
Canada	Investigational Site Number 124005	Sudbury
Canada	Investigational Site Number 124002	Thetford Mines
Chile	Investigational Site Number 152024	Antofagasta
Chile	Investigational Site Number 152023	Concepcion
Chile	Investigational Site Number 152041	Osorno
Chile	Investigational Site Number 152040	Puerto Montt
Chile	Investigational Site Number 152038	Punta Arenas
Chile	Investigational Site Number 152036	San Felipe
Chile	Investigational Site Number 152001	Santiago
Chile	Investigational Site Number 152004	Santiago
Chile	Investigational Site Number 152008	Santiago
Chile	Investigational Site Number 152011	Santiago
Chile	Investigational Site Number 152013	Santiago
Chile	Investigational Site Number 152015	Santiago
Chile	Investigational Site Number 152018	Santiago
Chile	Investigational Site Number 152019	Santiago
Chile	Investigational Site Number 152020	Santiago
Chile	Investigational Site Number 152022	Santiago
Chile	Investigational Site Number 152028	Santiago
Chile	Investigational Site Number 152029	Santiago
Chile	Investigational Site Number 152031	Santiago
Chile	Investigational Site Number 152034	Santiago
Chile	Investigational Site Number 152035	Santiago
Chile	Investigational Site Number 152042	Santiago
Chile	Investigational Site Number 152025	Talca
Chile	Investigational Site Number 152003	Temuco
Chile	Investigational Site Number 152014	Temuco
Chile	Investigational Site Number 152037	Valdivia
Chile	Investigational Site Number 152032	Valparaíso
Chile	Investigational Site Number 152002	Vina Del Mar
Chile	Investigational Site Number 152010	Viña Del Mar
China	Investigational Site Number 156001	Beijing
China	Investigational Site Number 156005	Beijing
China	Investigational Site Number 156006	Beijing
China	Investigational Site Number 156014	Beijing
China	Investigational Site Number 156016	Beijing
China	Investigational Site Number 156024	Beijing
China	Investigational Site Number 156028	Beijing
China	Investigational Site Number 156034	Beijing
China	Investigational Site Number 156008	Dalian
China	Investigational Site Number 156020	Guangzhou
China	Investigational Site Number 156015	Jinan
China	Investigational Site Number 156023	Jinan
China	Investigational Site Number 156009	Nanjing
China	Investigational Site Number 156013	Shanghai
China	Investigational Site Number 156019	Shanghai
China	Investigational Site Number 156022	Shenyang
China	Investigational Site Number 156032	Shenyang
China	Investigational Site Number 156004	Suzhou
China	Investigational Site Number 156033	Urumchi
Colombia	Investigational Site Number 170025	Armenia
Colombia	Investigational Site Number 170009	Barranquilla
Colombia	Investigational Site Number 170010	Barranquilla
Colombia	Investigational Site Number 170002	Bogota
Colombia	Investigational Site Number 170005	Bogota
Colombia	Investigational Site Number 170012	Bogota
Colombia	Investigational Site Number 170014	Bogota
Colombia	Investigational Site Number 170022	Bogota
Colombia	Investigational Site Number 170004	Bucaramanga
Colombia	Investigational Site Number 170017	Cali
Colombia	Investigational Site Number 170024	Cali
Colombia	Investigational Site Number 170013	Cartagena
Colombia	Investigational Site Number 170026	Espinal - Tolima
Colombia	Investigational Site Number 170007	Floridablanca
Colombia	Investigational Site Number 170008	Floridablanca
Colombia	Investigational Site Number 170019	Manizales
Colombia	Investigational Site Number 170003	Medellin
Colombia	Investigational Site Number 170020	Medellin
Colombia	Investigational Site Number 170021	Pereira
Denmark	Investigational Site Number 208003	Aarhus
Denmark	Investigational Site Number 208009	Aarhus C
Denmark	Investigational Site Number 208011	Esbjerg
Denmark	Investigational Site Number 208004	Farsø
Denmark	Investigational Site Number 208002	Hellerup
Denmark	Investigational Site Number 208010	Herlev
Denmark	Investigational Site Number 208008	Hillerød
Denmark	Investigational Site Number 208006	Hvidovre
Denmark	Investigational Site Number 208001	København Nv
Denmark	Investigational Site Number 208007	København Ø
Denmark	Investigational Site Number 208005	København S
Ecuador	Investigational Site Number 218001	Guayaquil
Ecuador	Investigational Site Number 218005	Guayaquil
Ecuador	Investigational Site Number 218002	Quito
Egypt	Investigational Site Number 818002	Alexandria
Egypt	Investigational Site Number 818001	Cairo
Estonia	Investigational Site Number 233001	Tallinn
Estonia	Investigational Site Number 233002	Tallinn
Estonia	Investigational Site Number 233003	Tallinn
Estonia	Investigational Site Number 233004	Tallinn
Estonia	Investigational Site Number 233005	Tartu
Estonia	Investigational Site Number 233006	Viljandimaa
Finland	Investigational Site Number 246005	Jyväskylä
Finland	Investigational Site Number 246003	Rauma
Finland	Investigational Site Number 246010	Tampere
Finland	Investigational Site Number 246009	Turku
Finland	Investigational Site Number 246007	Valkeakoski
Finland	Investigational Site Number 246012	Vantaa
France	Investigational Site Number 250008	Brest Cedex
France	Investigational Site Number 250002	Corbeil Essonnes
France	Investigational Site Number 250005	Nantes
France	Investigational Site Number 250014	Nimes
France	Investigational Site Number 250007	Paris Cedex 15
France	Investigational Site Number 250011	Pessac
France	Investigational Site Number 250012	Poitiers Cedex
France	Investigational Site Number 250006	Rennes
France	Investigational Site Number 250001	Toulouse Cedex 4
Georgia	Investigational Site Number 268003	Batumi
Georgia	Investigational Site Number 268004	Kutaisi
Georgia	Investigational Site Number 268001	Tbilisi
Georgia	Investigational Site Number 268002	Tbilisi
Germany	Investigational Site Number 276003	Berlin
Germany	Investigational Site Number 276022	Bochum
Germany	Investigational Site Number 276005	Chemnitz
Germany	Investigational Site Number 276021	Dresden
Germany	Investigational Site Number 276024	Dresden
Germany	Investigational Site Number 276007	Elsterwerda
Germany	Investigational Site Number 276018	Frankfurt A.M.
Germany	Investigational Site Number 276011	Frankfurt Am Main
Germany	Investigational Site Number 276017	Görlitz
Germany	Investigational Site Number 276025	Haßloch
Germany	Investigational Site Number 276009	Heidelberg
Germany	Investigational Site Number 276019	Leipzig
Germany	Investigational Site Number 276020	Magdeburg
Germany	Investigational Site Number 276028	Mühldorf Am Inn
Germany	Investigational Site Number 276014	Pirna
Germany	Investigational Site Number 276016	Pohlheim
Germany	Investigational Site Number 276026	Rotenburg An Der Fulda
Guatemala	Investigational Site Number 320001	Guatemala
Guatemala	Investigational Site Number 320002	Guatemala
Guatemala	Investigational Site Number 320004	Guatemala
Guatemala	Investigational Site Number 320006	Guatemala
Guatemala	Investigational Site Number 320007	Guatemala
Guatemala	Investigational Site Number 320008	Guatemala
Guatemala	Investigational Site Number 320011	Guatemala
Guatemala	Investigational Site Number 320012	Guatemala
Guatemala	Investigational Site Number 320014	Guatemala
Guatemala	Investigational Site Number 320015	Quetzaltenango
India	Investigational Site Number 356019	Ahmedabad
India	Investigational Site Number 356002	Bangalore
India	Investigational Site Number 356010	Bangalore
India	Investigational Site Number 356026	Bangalore
India	Investigational Site Number 356024	Belgaum
India	Investigational Site Number 356012	Chandigarh
India	Investigational Site Number 356016	Cochin
India	Investigational Site Number 356022	Gurgaon
India	Investigational Site Number 356029	Hubli
India	Investigational Site Number 356020	Hyderabad
India	Investigational Site Number 356031	Jaipur
India	Investigational Site Number 356004	Kolkata
India	Investigational Site Number 356014	Lucknow
India	Investigational Site Number 356015	Lucknow
India	Investigational Site Number 356009	Ludhiana
India	Investigational Site Number 356025	Madurai
India	Investigational Site Number 356032	Mangalore
India	Investigational Site Number 356018	Manipal
India	Investigational Site Number 356023	Mysore
India	Investigational Site Number 356006	Nagpur
India	Investigational Site Number 356027	Nagpur
India	Investigational Site Number 356034	Nashik
India	Investigational Site Number 356030	Nasik
India	Investigational Site Number 356013	New Delhi
India	Investigational Site Number 356017	New Delhi
India	Investigational Site Number 356021	Pune
India	Investigational Site Number 356028	Pune
Israel	Investigational Site Number 376010	Afula
Israel	Investigational Site Number 376006	Givatayim
Israel	Investigational Site Number 376002	Haifa
Israel	Investigational Site Number 376008	Haifa
Israel	Investigational Site Number 376001	Holon
Israel	Investigational Site Number 376012	Jerusalem
Israel	Investigational Site Number 376011	Nahariya
Israel	Investigational Site Number 376005	Safed
Israel	Investigational Site Number 376004	Tel Aviv
Israel	Investigational Site Number 376003	Tel Hashomer
Israel	Investigational Site Number 376009	Tzrifin
Italy	Investigational Site Number 380024	Carpi
Italy	Investigational Site Number 380004	Chieri
Italy	Investigational Site Number 380002	Chieti
Italy	Investigational Site Number 380006	Fermo
Italy	Investigational Site Number 380010	Firenze
Italy	Investigational Site Number 380009	Genova
Italy	Investigational Site Number 380016	Messina
Italy	Investigational Site Number 380011	Milano
Italy	Investigational Site Number 380012	Milano
Italy	Investigational Site Number 380023	Milano
Italy	Investigational Site Number 380014	Napoli
Italy	Investigational Site Number 380019	Novara
Italy	Investigational Site Number 380005	Palermo
Italy	Investigational Site Number 380001	Pisa
Italy	Investigational Site Number 380013	Roma
Italy	Investigational Site Number 380020	Rozzano
Japan	Investigational Site Number 392011	Chuo-Ku
Japan	Investigational Site Number 392015	Fuchu-Shi
Japan	Investigational Site Number 392012	Fujisawa-Shi
Japan	Investigational Site Number 392025	Hachioji-Shi
Japan	Investigational Site Number 392027	Hakusan-Shi
Japan	Investigational Site Number 392005	Hamamatsu-Shi
Japan	Investigational Site Number 392022	Hitachi-Shi
Japan	Investigational Site Number 392003	Itabashi-Ku
Japan	Investigational Site Number 392017	Itabashi-Ku
Japan	Investigational Site Number 392019	Kawanishi-Shi
Japan	Investigational Site Number 392013	Kobe-Shi
Japan	Investigational Site Number 392007	Matsuyama-Shi
Japan	Investigational Site Number 392008	Matsuyama-Shi
Japan	Investigational Site Number 392009	Nagasaki-Shi
Japan	Investigational Site Number 392002	Noda-Shi
Japan	Investigational Site Number 392020	Osaka-Shi
Japan	Investigational Site Number 392021	Osaka-Shi
Japan	Investigational Site Number 392001	Sapporo-Shi
Japan	Investigational Site Number 392010	Sapporo-Shi
Japan	Investigational Site Number 392024	Setagaya-Ku
Japan	Investigational Site Number 392004	Shinagawa-Ku
Japan	Investigational Site Number 392014	Shirakawa-Shi
Japan	Investigational Site Number 392018	Suita-Shi
Japan	Investigational Site Number 392016	Tachikawa-Shi
Japan	Investigational Site Number 392023	Takasaki-Shi
Korea, Republic of	Investigational Site Number 410012	Bucheon
Korea, Republic of	Investigational Site Number 410006	Daegu
Korea, Republic of	Investigational Site Number 410009	Gwangju
Korea, Republic of	Investigational Site Number 410001	Incheon
Korea, Republic of	Investigational Site Number 410008	Incheon
Korea, Republic of	Investigational Site Number 410004	Seongnam
Korea, Republic of	Investigational Site Number 410002	Seoul
Korea, Republic of	Investigational Site Number 410010	Seoul
Korea, Republic of	Investigational Site Number 410011	Seoul
Korea, Republic of	Investigational Site Number 410013	Seoul
Korea, Republic of	Investigational Site Number 410014	Seoul
Korea, Republic of	Investigational Site Number 410007	Wonju
Latvia	Investigational Site Number 428005	Cesis
Latvia	Investigational Site Number 428001	Daugavpils
Latvia	Investigational Site Number 428002	Liepaja
Latvia	Investigational Site Number 428003	Riga
Latvia	Investigational Site Number 428004	Riga
Latvia	Investigational Site Number 428007	Riga
Latvia	Investigational Site Number 428006	Sigulda
Lithuania	Investigational Site Number 440002	Kaunas
Lithuania	Investigational Site Number 440003	Kaunas
Lithuania	Investigational Site Number 440004	Klaipeda
Lithuania	Investigational Site Number 440006	Klaipeda
Lithuania	Investigational Site Number 440005	Panevezys
Lithuania	Investigational Site Number 440001	Vilnius
Mexico	Investigational Site Number 484011	Acapulco
Mexico	Investigational Site Number 484008	Aguascalientes
Mexico	Investigational Site Number 484033	Aguascalientes
Mexico	Investigational Site Number 484016	Chihuahua
Mexico	Investigational Site Number 484023	Ciudad Madero
Mexico	Investigational Site Number 484001	Durango
Mexico	Investigational Site Number 484007	Durango
Mexico	Investigational Site Number 484041	Durango
Mexico	Investigational Site Number 484006	Guadalajara
Mexico	Investigational Site Number 484014	Guadalajara
Mexico	Investigational Site Number 484018	Guadalajara
Mexico	Investigational Site Number 484021	Guadalajara
Mexico	Investigational Site Number 484028	Guadalajara
Mexico	Investigational Site Number 484032	Guadalajara
Mexico	Investigational Site Number 484034	Guadalajara
Mexico	Investigational Site Number 484024	Leon
Mexico	Investigational Site Number 484013	Mexico City
Mexico	Investigational Site Number 484022	Mexico City
Mexico	Investigational Site Number 484026	Mexico City
Mexico	Investigational Site Number 484002	Monterrey
Mexico	Investigational Site Number 484003	Monterrey
Mexico	Investigational Site Number 484004	Monterrey
Mexico	Investigational Site Number 484005	Monterrey
Mexico	Investigational Site Number 484025	Monterrey
Mexico	Investigational Site Number 484035	Morelia
Mexico	Investigational Site Number 484020	San Luis Potosi
Mexico	Investigational Site Number 484017	Tlalnepantla
Mexico	Investigational Site Number 484031	Xalapa
Netherlands	Investigational Site Number 528005	Alkmaar
Netherlands	Investigational Site Number 528007	Den Haag
Netherlands	Investigational Site Number 528008	Deventer
Netherlands	Investigational Site Number 528004	Hoorn
Netherlands	Investigational Site Number 528001	Rotterdam
Netherlands	Investigational Site Number 528003	Tilburg
Netherlands	Investigational Site Number 528006	Venlo
Norway	Investigational Site Number 578003	Bodø
Norway	Investigational Site Number 578002	Haugesund
Norway	Investigational Site Number 578001	Stavanger
Panama	Investigational Site Number 591001	Cuidad De Panama
Panama	Investigational Site Number 591003	Cuidad De Panama
Panama	Investigational Site Number 591004	La Chorrera
Panama	Investigational Site Number 591002	Penonome
Peru	Investigational Site Number 604007	Arequipa
Peru	Investigational Site Number 604014	Callao
Peru	Investigational Site Number 604001	Lima
Peru	Investigational Site Number 604002	Lima
Peru	Investigational Site Number 604005	Lima
Peru	Investigational Site Number 604006	Lima
Peru	Investigational Site Number 604009	Lima
Peru	Investigational Site Number 604010	Lima
Peru	Investigational Site Number 604011	Lima
Peru	Investigational Site Number 604013	Lima
Peru	Investigational Site Number 604015	Lima
Peru	Investigational Site Number 604016	Lima
Peru	Investigational Site Number 604017	Lima
Peru	Investigational Site Number 604018	Lima
Peru	Investigational Site Number 604019	Lima
Philippines	Investigational Site Number 608006	Cavite
Philippines	Investigational Site Number 608009	Iligan City, Lanao Del Norte
Philippines	Investigational Site Number 608003	Makati City
Philippines	Investigational Site Number 608001	Manila
Philippines	Investigational Site Number 608007	Manila
Philippines	Investigational Site Number 608005	Marikina City
Philippines	Investigational Site Number 608002	Pasay City
Philippines	Investigational Site Number 608008	Quezon City
Poland	Investigational Site Number 616005	?ód?
Poland	Investigational Site Number 616008	Bialystok
Poland	Investigational Site Number 616019	Bydgoszcz
Poland	Investigational Site Number 616012	Czeladz
Poland	Investigational Site Number 616007	Czestochowa
Poland	Investigational Site Number 616014	Gdynia
Poland	Investigational Site Number 616013	Gliwice
Poland	Investigational Site Number 616028	Grodzisk Mazowiecki
Poland	Investigational Site Number 616022	Katowice
Poland	Investigational Site Number 616001	Krakow
Poland	Investigational Site Number 616024	Krakow
Poland	Investigational Site Number 616029	Leczyca
Poland	Investigational Site Number 616023	Poland
Poland	Investigational Site Number 616021	Pulawy
Poland	Investigational Site Number 616006	Ruda Slaska
Poland	Investigational Site Number 616025	Szczecin
Poland	Investigational Site Number 616032	Warszawa
Poland	Investigational Site Number 616011	Wroclaw
Poland	Investigational Site Number 616020	Wroclaw
Poland	Investigational Site Number 616031	Zgierz
Portugal	Investigational Site Number 620005	Amadora
Portugal	Investigational Site Number 620003	Coimbra
Portugal	Investigational Site Number 620001	Lisboa
Portugal	Investigational Site Number 620007	Penafiel
Portugal	Investigational Site Number 620006	Porto
Romania	Investigational Site Number 642029	Arad
Romania	Investigational Site Number 642020	Baia Mare
Romania	Investigational Site Number 642019	Braila
Romania	Investigational Site Number 642003	Brasov
Romania	Investigational Site Number 642034	Bucharest
Romania	Investigational Site Number 642001	Bucuresti
Romania	Investigational Site Number 642013	Bucuresti
Romania	Investigational Site Number 642022	Bucuresti
Romania	Investigational Site Number 642026	Cluj Napoca
Romania	Investigational Site Number 642015	Craiova
Romania	Investigational Site Number 642030	Craiova
Romania	Investigational Site Number 642007	Deva
Romania	Investigational Site Number 642010	Iasi
Romania	Investigational Site Number 642011	Iasi
Romania	Investigational Site Number 642016	Oradea
Romania	Investigational Site Number 642033	Pitesti
Romania	Investigational Site Number 642002	Ploiesti
Romania	Investigational Site Number 642009	Suceava
Romania	Investigational Site Number 642012	Targu Mures
Romania	Investigational Site Number 642014	Targu Mures
Romania	Investigational Site Number 642018	Timisoara
Romania	Investigational Site Number 642031	Timisoara
Russian Federation	Investigational Site Number 643023	Barnaul
Russian Federation	Investigational Site Number 643044	Kazan
Russian Federation	Investigational Site Number 643005	Kemerovo
Russian Federation	Investigational Site Number 643006	Kemerovo
Russian Federation	Investigational Site Number 643027	Krasnodar
Russian Federation	Investigational Site Number 643061	Krasnodar
Russian Federation	Investigational Site Number 643001	Moscow
Russian Federation	Investigational Site Number 643002	Moscow
Russian Federation	Investigational Site Number 643003	Moscow
Russian Federation	Investigational Site Number 643008	Moscow
Russian Federation	Investigational Site Number 643009	Moscow
Russian Federation	Investigational Site Number 643013	Moscow
Russian Federation	Investigational Site Number 643018	Moscow
Russian Federation	Investigational Site Number 643026	Moscow
Russian Federation	Investigational Site Number 643029	Moscow
Russian Federation	Investigational Site Number 643037	Moscow
Russian Federation	Investigational Site Number 643038	Moscow
Russian Federation	Investigational Site Number 643040	Moscow
Russian Federation	Investigational Site Number 643042	Moscow
Russian Federation	Investigational Site Number 643043	Moscow
Russian Federation	Investigational Site Number 643051	Moscow
Russian Federation	Investigational Site Number 643052	Moscow
Russian Federation	Investigational Site Number 643060	Moscow
Russian Federation	Investigational Site Number 643034	Nizhny Novgorod
Russian Federation	Investigational Site Number 643054	Novosibirsk
Russian Federation	Investigational Site Number 643055	Novosibirsk
Russian Federation	Investigational Site Number 643045	Omsk
Russian Federation	Investigational Site Number 643030	Penza
Russian Federation	Investigational Site Number 643017	Perm
Russian Federation	Investigational Site Number 643049	Perm
Russian Federation	Investigational Site Number 643048	Rostov-Na-Donu
Russian Federation	Investigational Site Number 643047	Ryazan
Russian Federation	Investigational Site Number 643039	Saint-Petersburg
Russian Federation	Investigational Site Number 643010	Saratov
Russian Federation	Investigational Site Number 643019	Saratov
Russian Federation	Investigational Site Number 643025	Saratov
Russian Federation	Investigational Site Number 643033	Saratov
Russian Federation	Investigational Site Number 643056	Saratov
Russian Federation	Investigational Site Number 643014	Smolensk
Russian Federation	Investigational Site Number 643004	St-Petersburg
Russian Federation	Investigational Site Number 643011	St-Petersburg
Russian Federation	Investigational Site Number 643022	St-Petersburg
Russian Federation	Investigational Site Number 643024	St-Petersburg
Russian Federation	Investigational Site Number 643031	St-Petersburg
Russian Federation	Investigational Site Number 643035	St-Petersburg
Russian Federation	Investigational Site Number 643036	St-Petersburg
Russian Federation	Investigational Site Number 643041	St-Petersburg
Russian Federation	Investigational Site Number 643057	St-Petersburg
Russian Federation	Investigational Site Number 643028	Tomsk
Russian Federation	Investigational Site Number 643016	Tver
Russian Federation	Investigational Site Number 643012	Tyumen
Russian Federation	Investigational Site Number 643059	Vladimir
Russian Federation	Investigational Site Number 643058	Voronezh
Russian Federation	Investigational Site Number 643020	Yaroslavl
Russian Federation	Investigational Site Number 643062	Yaroslavl
Serbia	Investigational Site Number 688001	Belgrade
Serbia	Investigational Site Number 688002	Belgrade
Serbia	Investigational Site Number 688003	Belgrade
Serbia	Investigational Site Number 688004	Belgrade
Serbia	Investigational Site Number 688006	Belgrade
Serbia	Investigational Site Number 688008	Belgrade
Serbia	Investigational Site Number 688009	Belgrade
Serbia	Investigational Site Number 688010	Belgrade
Serbia	Investigational Site Number 688005	Nis
Serbia	Investigational Site Number 688007	Nis
South Africa	Investigational Site Number 710020	Alberton
South Africa	Investigational Site Number 710006	Cape Town
South Africa	Investigational Site Number 710010	Cape Town
South Africa	Investigational Site Number 710017	Cape Town
South Africa	Investigational Site Number 710025	Cape Town
South Africa	Investigational Site Number 710008	Chatsworth
South Africa	Investigational Site Number 710011	Durban
South Africa	Investigational Site Number 710015	George
South Africa	Investigational Site Number 710019	Kempton Park
South Africa	Investigational Site Number 710014	Paarl
South Africa	Investigational Site Number 710023	Parow
South Africa	Investigational Site Number 710001	Pretoria
South Africa	Investigational Site Number 710002	Pretoria
South Africa	Investigational Site Number 710005	Richards Bay
South Africa	Investigational Site Number 710007	Somerset West
South Africa	Investigational Site Number 710004	Worcester
Spain	Investigational Site Number 724005	Alcalá De Henares
Spain	Investigational Site Number 724016	Almería
Spain	Investigational Site Number 724012	Barakaldo
Spain	Investigational Site Number 724018	Barcelona
Spain	Investigational Site Number 724014	Bilbao
Spain	Investigational Site Number 724015	Cáceres
Spain	Investigational Site Number 724013	La Coruña
Spain	Investigational Site Number 724008	Lérida
Spain	Investigational Site Number 724011	Madrid
Spain	Investigational Site Number 724017	Murcia
Spain	Investigational Site Number 724022	Oviedo
Spain	Investigational Site Number 724003	Pontevedra
Spain	Investigational Site Number 724001	Sevilla
Spain	Investigational Site Number 724020	Valencia
Spain	Investigational Site Number 724004	Vigo
Sweden	Investigational Site Number 752012	Karlstad
Sweden	Investigational Site Number 752011	Kristianstad
Sweden	Investigational Site Number 752006	Ljungby
Sweden	Investigational Site Number 752009	Oskarshamn
Sweden	Investigational Site Number 752004	Stockholm
Sweden	Investigational Site Number 752007	Stockholm
Sweden	Investigational Site Number 752002	Växjö
Switzerland	Investigational Site Number 756003	Lugano
Taiwan	Investigational Site Number 158005	Chia-Yi
Taiwan	Investigational Site Number 158004	Taichung
Taiwan	Investigational Site Number 158006	Tainan Hsien
Taiwan	Investigational Site Number 158001	Taipei
Taiwan	Investigational Site Number 158002	Taipei
Taiwan	Investigational Site Number 158008	Taipei
Taiwan	Investigational Site Number 158007	Taipei 111
Taiwan	Investigational Site Number 158003	Taipei Hsien
Tunisia	Investigational Site Number 788003	Sfax
Tunisia	Investigational Site Number 788001	Tunis
Tunisia	Investigational Site Number 788002	Tunis
Tunisia	Investigational Site Number 788004	Tunis
Tunisia	Investigational Site Number 788005	Tunis
Turkey	Investigational Site Number 792002	Ankara
Turkey	Investigational Site Number 792004	Ankara
Turkey	Investigational Site Number 792012	Ankara
Turkey	Investigational Site Number 792001	Capa / Istanbul
Turkey	Investigational Site Number 792008	Istanbul
Turkey	Investigational Site Number 792014	Istanbul
Turkey	Investigational Site Number 792015	Istanbul
Turkey	Investigational Site Number 792003	Izmir
Turkey	Investigational Site Number 792007	Izmir
Turkey	Investigational Site Number 792011	Mersin
Turkey	Investigational Site Number 792013	Samsun
Ukraine	Investigational Site Number 804004	Chernivtsi
Ukraine	Investigational Site Number 804006	Dnepropetrovsk
Ukraine	Investigational Site Number 804002	Dnipropetrovsk
Ukraine	Investigational Site Number 804010	Kharkiv
Ukraine	Investigational Site Number 804009	Kharkov
Ukraine	Investigational Site Number 804003	Kiev
Ukraine	Investigational Site Number 804011	Kiev
Ukraine	Investigational Site Number 804012	Kyiv
Ukraine	Investigational Site Number 804013	Kyiv
Ukraine	Investigational Site Number 804005	Lviv
Ukraine	Investigational Site Number 804007	Odessa
Ukraine	Investigational Site Number 804008	Odessa
United Arab Emirates	Investigational Site Number 784001	Abu Dhabi
United Arab Emirates	Investigational Site Number 784002	Dubai
United Kingdom	Investigational Site Number 826042	Antrim
United Kingdom	Investigational Site Number 826002	Ashton-Under-Lyne
United Kingdom	Investigational Site Number 826026	Barnstaple
United Kingdom	Investigational Site Number 826017	Bath
United Kingdom	Investigational Site Number 826034	Birmingham
United Kingdom	Investigational Site Number 826052	Bolton
United Kingdom	Investigational Site Number 826005	Bradford
United Kingdom	Investigational Site Number 826048	Carmarthen
United Kingdom	Investigational Site Number 826037	Chester
United Kingdom	Investigational Site Number 826011	Dumfries
United Kingdom	Investigational Site Number 826044	East Kilbride
United Kingdom	Investigational Site Number 826023	Edinburgh
United Kingdom	Investigational Site Number 826008	Glasgow
United Kingdom	Investigational Site Number 826010	Harrogate
United Kingdom	Investigational Site Number 826040	Ipswich
United Kingdom	Investigational Site Number 826033	Larbert
United Kingdom	Investigational Site Number 826027	Liverpool
United Kingdom	Investigational Site Number 826039	Londonderry
United Kingdom	Investigational Site Number 826006	Manchester
United Kingdom	Investigational Site Number 826021	Manchester
United Kingdom	Investigational Site Number 826036	Manchester
United Kingdom	Investigational Site Number 826049	Norwich
United Kingdom	Investigational Site Number 826020	Nuneaton
United Kingdom	Investigational Site Number 826009	Oldham
United Kingdom	Investigational Site Number 826007	Salford
United Kingdom	Investigational Site Number 826045	Stoke-On-Trent
United Kingdom	Investigational Site Number 826038	Swansea
United Kingdom	Investigational Site Number 826018	Taunton
United Kingdom	Investigational Site Number 826016	Truro
United Kingdom	Investigational Site Number 826046	Wolverhampton
United Kingdom	Investigational Site Number 826019	Yeovil
United States	Investigational Site Number 840285	Albany	New York
United States	Investigational Site Number 840019	Alpena	Michigan
United States	Investigational Site Number 840232	American Fork	Utah
United States	Investigational Site Number 840497	Anaheim	California
United States	Investigational Site Number 840706	Anaheim	California
United States	Investigational Site Number 840223	Anderson	South Carolina
United States	Investigational Site Number 840043	Annapolis	Maryland
United States	Investigational Site Number 840519	Arlington Heights	Illinois
United States	Investigational Site Number 840310	Asheville	North Carolina
United States	Investigational Site Number 840066	Atlanta	Georgia
United States	Investigational Site Number 840446	Atlanta	Georgia
United States	Investigational Site Number 840487	Atlanta	Georgia
United States	Investigational Site Number 840524	Bartlett	Tennessee
United States	Investigational Site Number 840299	Baton Rouge	Louisiana
United States	Investigational Site Number 840589	Belleville	Illinois
United States	Investigational Site Number 840427	Bend	Oregon
United States	Investigational Site Number 840196	Biloxi	Mississippi
United States	Investigational Site Number 840415	Birmingham	Alabama
United States	Investigational Site Number 840578	Blue Ridge	Georgia
United States	Investigational Site Number 840352	Buckley	Michigan
United States	Investigational Site Number 840560	Butler	Pennsylvania
United States	Investigational Site Number 840454	Calabash	North Carolina
United States	Investigational Site Number 840639	Catonsville	Maryland
United States	Investigational Site Number 840152	Charlotte	North Carolina
United States	Investigational Site Number 840672	Charlotte	North Carolina
United States	Investigational Site Number 840503	Charlottesville	Virginia
United States	Investigational Site Number 840308	Chattanooga	Tennessee
United States	Investigational Site Number 840128	Chesapeake	Virginia
United States	Investigational Site Number 840180	Chesapeake	Virginia
United States	Investigational Site Number 840465	Chesapeake	Virginia
United States	Investigational Site Number 840555	Chesterfield	Michigan
United States	Investigational Site Number 840107	Chicago	Illinois
United States	Investigational Site Number 840633	Chicago	Illinois
United States	Investigational Site Number 840663	Chicago	Illinois
United States	Investigational Site Number 840028	Cincinnati	Ohio
United States	Investigational Site Number 840198	Cincinnati	Ohio
United States	Investigational Site Number 840464	Clark Summit	Pennsylvania
United States	Investigational Site Number 840281	Clearwater	Florida
United States	Investigational Site Number 840093	Colorado Springs	Colorado
United States	Investigational Site Number 840353	Columbia	South Carolina
United States	Investigational Site Number 840534	Columbus	Georgia
United States	Investigational Site Number 840543	Columbus	Ohio
United States	Investigational Site Number 840533	Covington	Kentucky
United States	Investigational Site Number 840473	Dallas	Texas
United States	Investigational Site Number 840456	Dayton	Ohio
United States	Investigational Site Number 840411	Dearborn	Michigan
United States	Investigational Site Number 840205	Detroit	Michigan
United States	Investigational Site Number 840667	Downey	California
United States	Investigational Site Number 840471	Draper	Utah
United States	Investigational Site Number 840219	Duluth	Minnesota
United States	Investigational Site Number 840447	Duluth	Georgia
United States	Investigational Site Number 840499	Duluth	Georgia
United States	Investigational Site Number 840199	Eagan	Minnesota
United States	Investigational Site Number 840677	Edinburg	Texas
United States	Investigational Site Number 840698	El Paso	Texas
United States	Investigational Site Number 840344	Elizabeth City	North Carolina
United States	Investigational Site Number 840360	Elwood	Indiana
United States	Investigational Site Number 840439	Fair Oaks Ranch	Texas
United States	Investigational Site Number 840613	Fairmount	Wisconsin
United States	Investigational Site Number 840581	Flint	Michigan
United States	Investigational Site Number 840307	Foley	Alabama
United States	Investigational Site Number 840150	Fresno	California
United States	Investigational Site Number 840676	Gary	Indiana
United States	Investigational Site Number 840047	Germantown	Tennessee
United States	Investigational Site Number 840529	Green Ville	South Carolina
United States	Investigational Site Number 840328	Greensboro	North Carolina
United States	Investigational Site Number 840513	Greensboro	North Carolina
United States	Investigational Site Number 840504	Greenville	North Carolina
United States	Investigational Site Number 840550	Greer	South Carolina
United States	Investigational Site Number 840657	Hammond	Indiana
United States	Investigational Site Number 840671	Hammond	Louisiana
United States	Investigational Site Number 840624	Hawthorne	California
United States	Investigational Site Number 840212	Hines	Illinois
United States	Investigational Site Number 840477	Homosassa	Florida
United States	Investigational Site Number 840303	Hot Springs	Arkansas
United States	Investigational Site Number 840164	Houston	Texas
United States	Investigational Site Number 840621	Huntington	Indiana
United States	Investigational Site Number 840536	Idaho Falls	Idaho
United States	Investigational Site Number 840702	Indianapolis	Indiana
United States	Investigational Site Number 840623	Inglewood	California
United States	Investigational Site Number 840636	Inglewood	California
United States	Investigational Site Number 840313	Jackson	Tennessee
United States	Investigational Site Number 840585	Jamaica	New York
United States	Investigational Site Number 840345	Joliet	Illinois
United States	Investigational Site Number 840184	Jonesboro	Arkansas
United States	Investigational Site Number 840404	Kalamazoo	Michigan
United States	Investigational Site Number 840337	Kalispell	Montana
United States	Investigational Site Number 840008	Kansas City	Missouri
United States	Investigational Site Number 840445	Kansas City	Missouri
United States	Investigational Site Number 840455	La Mesa	California
United States	Investigational Site Number 840121	Lacrosse	Wisconsin
United States	Investigational Site Number 840217	Las Vegas	Nevada
United States	Investigational Site Number 840382	Las Vegas	Nevada
United States	Investigational Site Number 840680	Las Vegas	Nevada
United States	Investigational Site Number 840509	Lincoln	Nebraska
United States	Investigational Site Number 840072	Linden	New Jersey
United States	Investigational Site Number 840023	Little Rock	Arkansas
United States	Investigational Site Number 840361	Little Rock	Arkansas
United States	Investigational Site Number 840240	Loma Linda	California
United States	Investigational Site Number 840262	Long Beach	California
United States	Investigational Site Number 840606	Long Beach	California
United States	Investigational Site Number 840545	Longview	Texas
United States	Investigational Site Number 840135	Los Angeles	California
United States	Investigational Site Number 840431	Los Angeles	California
United States	Investigational Site Number 840694	Los Angeles	California
United States	Investigational Site Number 840385	Lubbock	Texas
United States	Investigational Site Number 840530	Lubbock	Texas
United States	Investigational Site Number 840251	Madisonville	Kentucky
United States	Investigational Site Number 840368	Marion	Ohio
United States	Investigational Site Number 840174	Marshall	Texas
United States	Investigational Site Number 840625	Memphis	Tennessee
United States	Investigational Site Number 840637	Memphis	Tennessee
United States	Investigational Site Number 840314	Merced	California
United States	Investigational Site Number 840656	Mesa	Arizona
United States	Investigational Site Number 840470	Metairie	Louisiana
United States	Investigational Site Number 840261	Miami	Florida
United States	Investigational Site Number 840459	Miami	Florida
United States	Investigational Site Number 840493	Milwaukee	Wisconsin
United States	Investigational Site Number 840348	Mineola	New York
United States	Investigational Site Number 840290	Mission Viejo	California
United States	Investigational Site Number 840037	Mobile	Alabama
United States	Investigational Site Number 840210	Mobile	Alabama
United States	Investigational Site Number 840692	Mobile	Alabama
United States	Investigational Site Number 840642	Monroe	North Carolina
United States	Investigational Site Number 840326	Muscle Shoals	Alabama
United States	Investigational Site Number 840258	Myrtle Beach	South Carolina
United States	Investigational Site Number 840096	Nashville	Tennessee
United States	Investigational Site Number 840388	Nashville	Tennessee
United States	Investigational Site Number 840592	National City	California
United States	Investigational Site Number 840045	Norfolk	Virginia
United States	Investigational Site Number 840213	Norfolk	Virginia
United States	Investigational Site Number 840119	Northport	New York
United States	Investigational Site Number 840275	Northridge	California
United States	Investigational Site Number 840654	Oakland	California
United States	Investigational Site Number 840170	Olympia	Washington
United States	Investigational Site Number 840007	Omaha	Nebraska
United States	Investigational Site Number 840351	Orange	California
United States	Investigational Site Number 840689	Orange	California
United States	Investigational Site Number 840432	Oviedo	Florida
United States	Investigational Site Number 840168	Owensboro	Kentucky
United States	Investigational Site Number 840318	Panama City	Florida
United States	Investigational Site Number 840681	Peoria	Illinois
United States	Investigational Site Number 840322	Phoenix	Arizona
United States	Investigational Site Number 840506	Phoenix	Arizona
United States	Investigational Site Number 840520	Phoenix	Arizona
United States	Investigational Site Number 840449	Pikeville	Kentucky
United States	Investigational Site Number 840401	Pittsburgh	Pennsylvania
United States	Investigational Site Number 840565	Plano	Texas
United States	Investigational Site Number 840413	Pocatello	Idaho
United States	Investigational Site Number 840582	Pomona	California
United States	Investigational Site Number 840346	Port Hueneme	California
United States	Investigational Site Number 840422	Portland	Oregon
United States	Investigational Site Number 840511	Portland	Oregon
United States	Investigational Site Number 840266	Providence	Rhode Island
United States	Investigational Site Number 840481	Raleigh	North Carolina
United States	Investigational Site Number 840551	Rapid City	South Dakota
United States	Investigational Site Number 840001	Richmond	Virginia
United States	Investigational Site Number 840608	Richmond	Texas
United States	Investigational Site Number 840628	Ridgewood	New Jersey
United States	Investigational Site Number 840286	Roanoke	Virginia
United States	Investigational Site Number 840430	Rockville	Maryland
United States	Investigational Site Number 840696	Rosedale	New York
United States	Investigational Site Number 840466	Roseville	California
United States	Investigational Site Number 840573	San Antonio	Texas
United States	Investigational Site Number 840575	San Marino	California
United States	Investigational Site Number 840131	Santa Ana	California
United States	Investigational Site Number 840335	Santa Ana	California
United States	Investigational Site Number 840178	Shreveport	Louisiana
United States	Investigational Site Number 840576	Simi Valley	California
United States	Investigational Site Number 840162	Somerset	New Jersey
United States	Investigational Site Number 840312	Southfield	Michigan
United States	Investigational Site Number 840094	Spokane	Washington
United States	Investigational Site Number 840268	Spokane	Washington
United States	Investigational Site Number 840343	Spokane	Washington
United States	Investigational Site Number 840046	St. Louis	Missouri
United States	Investigational Site Number 840091	St. Louis	Missouri
United States	Investigational Site Number 840400	St. Louis	Missouri
United States	Investigational Site Number 840678	St. Louis	Missouri
United States	Investigational Site Number 840056	St. Petersburg	Florida
United States	Investigational Site Number 840484	Sterling Heights	Michigan
United States	Investigational Site Number 840564	Sugarland	Texas
United States	Investigational Site Number 840414	Sylmar	California
United States	Investigational Site Number 840061	Tacoma	Washington
United States	Investigational Site Number 840640	Takoma Park	Maryland
United States	Investigational Site Number 840309	Taylors	South Carolina
United States	Investigational Site Number 840250	Tempe	Arizona
United States	Investigational Site Number 840393	Toney	Alabama
United States	Investigational Site Number 840009	Topeka	Kansas
United States	Investigational Site Number 840293	Towson	Maryland
United States	Investigational Site Number 840042	Tucson	Arizona
United States	Investigational Site Number 840395	Ventura	California
United States	Investigational Site Number 840206	Vista	California
United States	Investigational Site Number 840241	Waco	Texas
United States	Investigational Site Number 840044	Washington	District of Columbia
United States	Investigational Site Number 840631	Washington	District of Columbia
United States	Investigational Site Number 840295	Wellington	Florida
United States	Investigational Site Number 840480	Westlake Village	California
United States	Investigational Site Number 840350	Whittier	California
United States	Investigational Site Number 840381	Wilmington	North Carolina
United States	Investigational Site Number 840532	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Denmark,  Ecuador,  Egypt,  Estonia,  Finland,  France,  Georgia,  Germany,  Guatemala,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  Norway,  Panama,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Tunisia,  Turkey,  Ukraine,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the first occurrence of the primary cardiovascular (CV) event: CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, positively adjudicated by the Cardiovascular Events Adjudication Committee (CAC)		week 0 to week 203	No
Secondary	Time to the first occurrence of cardiovascular (CV) death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure positively adjudicated by the CAC		week 0 to week 203	No
Secondary	Time to the first occurrence of cardiovascular (CV) death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure positively adjudicated by the CAC		week 0 to week 203	No
Secondary	Percent change in the urinary albumin/creatinine ratio		From baseline to 108 weeks	No