This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure

Heart Failure With Reduced Ejection Fraction Clinical Trial

— PARADIGM-HF  

Official title:

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035255
• Other study ID #: CLCZ696B2314
• Secondary ID: 2009-015834-31
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2009
• Last updated: September 9, 2015
• Start date: December 2009
• Est. completion date: May 2014

Study information

• Verified date: September 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: National Administration of Drugs, Foods and Medical TechnologyBelgium: Federal Agency for Medicines and Health Products, FAMHPBrazil: Ministry of HealthBulgaria: Ministry of HealthCanada: Health CanadaChile: Comisión Nacional de Investigación Científica y TecnológicaChina: Food and Drug AdministrationColombia: National Institute of Food and Drug VigilanceCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyEcuador: Public Health MinistryEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyFrance: Sanitary Safety of Health Products AgencyGermany: Federal Institute for Drugs and Medical DevicesGuatemala: Ministry of healthHong Kong: Department of HealthHungary: National Institute of PharmacyIceland: Icelandic Medicines Control AgencyIndia: Central Drug Standard OrganizationIsrael: Ministry of HealthItaly: National Institute of HealthKorea: Korea Food and Drug AdministrationLatvia: State Agency of MedicinesLithuania: State Medicines Control AgencyMalaysia: Ministry of HealthMexico: Ministry of HealthNetherlands: Medicines Evaluation BoardPanama: Ministry of HealthPeru: General Directorate of Pharmaceuticals, Devices, and DrugsPhilippines: Bureau of Food and DrugsPoland: Ministry of HealthPortugal: National Institute of Pharmacy and MedicinesRomania: National Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthSingapore: Center for Drug AdministrationSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSpain: Spanish Drug AgencySweden: Medical Products AgencyTaiwan: Department of HealthThailand: Ministry of Public HealthTurkey: General Directorate of Pharmaceuticals and PharmacyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyVenezuela: Ministry of Health and Social DevelopmentArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBelgium: Federal Agency for Medicinal Products and Health ProductsColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Guatemala: Ministry of Public Health and Social AssistanceIndia: Central Drugs Standard Control OrganizationKorea: Food and Drug AdministrationLithuania: State Medicine Control Agency - Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Portugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8442
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must give written informed consent before any assessment is performed.

• Outpatients = 18 years of age, male or female.

• Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF =< 35%) and elevated BNP.

• Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.

• Patients must be treated with a ß-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.

Exclusion Criteria:

• Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.

• History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.

• Previous history of intolerance to recommended target doses of ACEIs or ARBs

• Known history of angioedema.

• Requirement of treatment with both ACEIs and ARBs.

• Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).

• Symptomatic hypotension and/or a SBP < 100 mmHg.

• Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula

• Serum potassium > 5.2 mmol/L.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Drug:
• LCZ696 200 mg BID
LCZ696 200 mg BID
• Enalapril 10 mg BID
Enalapril 10 mg BID

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires	San Juan
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
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	Ciudad Autonoma de Bs As	Buenos Aires
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	Córdoba
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	Formosa
Argentina	Novartis Investigative Site	Formosa
Argentina	Novartis Investigative Site	Lanus	Buenos Aires
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Munro	Buenos Aires
Argentina	Novartis Investigative Site	Pilar	Buenos Aires
Argentina	Novartis Investigative Site	Quilmes	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	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 Juan
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 Salvador de Jujuy	Jujuy
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Santiago del Estero
Argentina	Novartis Investigative Site	Trelew	Chubut
Argentina	Novartis Investigative Site	Zarate	Buenos Aires
Belgium	Novartis Investigative Site	Antwerpen
Belgium	Novartis Investigative Site	Baudour
Belgium	Novartis Investigative Site	Bonheiden
Belgium	Novartis Investigative Site	Brasschaat
Belgium	Novartis Investigative Site	Brugge
Belgium	Novartis Investigative Site	Brussel
Belgium	Novartis Investigative Site	Brussels
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Hasselt
Belgium	Novartis Investigative Site	Heusden-Zolder
Belgium	Novartis Investigative Site	La Louvière
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Ottignies
Belgium	Novartis Investigative Site	Ronse
Brazil	Novartis Investigative Site	Belem	PA
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Brasilia	DF
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Goiania	GO
Brazil	Novartis Investigative Site	Goiania	GO
Brazil	Novartis Investigative Site	Goiania	GO
Brazil	Novartis Investigative Site	Marilia	SP
Brazil	Novartis Investigative Site	Natal	RN
Brazil	Novartis Investigative Site	Passo Fundo	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	Recife	PE
Brazil	Novartis Investigative Site	Recife	PE
Brazil	Novartis Investigative Site	Recife	PE
Brazil	Novartis Investigative Site	Ribeirao Preto	SP
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Salvador	BA
Brazil	Novartis Investigative Site	Salvador	BA
Brazil	Novartis Investigative Site	Santo Andre	SP
Brazil	Novartis Investigative Site	Santo Andre	SP
Brazil	Novartis Investigative Site	Sao Jose do Rio Preto	SP
Brazil	Novartis Investigative Site	Sao Luis	MA
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	São Paulo	SP
Brazil	Novartis Investigative Site	São Paulo	SP
Brazil	Novartis Investigative Site	Uberlândia	MG
Brazil	Novartis Investigative Site	Votuporanga	SP
Bulgaria	Novartis Investigative Site	Burgas
Bulgaria	Novartis Investigative Site	Haskovo
Bulgaria	Novartis Investigative Site	Pazardzhik
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Russe
Bulgaria	Novartis Investigative Site	Shumen
Bulgaria	Novartis Investigative Site	Silistra
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
Bulgaria	Novartis Investigative Site	Stara Zagora
Bulgaria	Novartis Investigative Site	Varna
Bulgaria	Novartis Investigative Site	Veliko Tarnovo
Canada	Novartis Investigative Site	Cambridge	Ontario
Canada	Novartis Investigative Site	Granby	Quebec
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Kitchener	Ontario
Canada	Novartis Investigative Site	Lachine	Quebec
Canada	Novartis Investigative Site	Laval	Quebec
Canada	Novartis Investigative Site	Lévis	Quebec
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Longueuil	Quebec
Canada	Novartis Investigative Site	Moncton	New Brunswick
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	New Westminster	British Columbia
Canada	Novartis Investigative Site	Oshawa	Ontario
Canada	Novartis Investigative Site	Regina	Saskatchewan
Canada	Novartis Investigative Site	Sainte-Foy	Quebec
Canada	Novartis Investigative Site	Sherbrooke	Quebec
Canada	Novartis Investigative Site	St-Georges Beauce	Quebec
Canada	Novartis Investigative Site	Sudbury	Ontario
Canada	Novartis Investigative Site	Surrey	British Columbia
Canada	Novartis Investigative Site	Thetford Mines	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Victoria	British Columbia
Canada	Novartis Investigative Site	Weston	Ontario
Chile	Novartis Investigative Site	Los Angeles	Bio Bio
Chile	Novartis Investigative Site	San Miguel	Santiago
Chile	Novartis Investigative Site	Santiago	Region Metropolitana
Chile	Novartis Investigative Site	Santiago
Chile	Novartis Investigative Site	Santiago
Chile	Novartis Investigative Site	Talcahuano
Chile	Novartis Investigative Site	Temuco	Cautin
Chile	Novartis Investigative Site	Temuco	Araucania
Chile	Novartis Investigative Site	Vitacura	Santiago
China	Novartis Investigative Site	Baotou
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	Changsha	Hunan
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Chongqing
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Harbin	Heilongjiang
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Xi'an	Shanxi
Colombia	Novartis Investigative Site	Barranquilla	Atlantico
Colombia	Novartis Investigative Site	Barranquilla
Colombia	Novartis Investigative Site	Bogota	Cundinamarca
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	Medellín
Czech Republic	Novartis Investigative Site	Beroun
Czech Republic	Novartis Investigative Site	Bilovec	CZE
Czech Republic	Novartis Investigative Site	Brandys nad Labem
Czech Republic	Novartis Investigative Site	Horovice
Czech Republic	Novartis Investigative Site	Jablonec nad Nisou
Czech Republic	Novartis Investigative Site	Karlovy Vary
Czech Republic	Novartis Investigative Site	Kladno
Czech Republic	Novartis Investigative Site	Klatovy
Czech Republic	Novartis Investigative Site	Kolin
Czech Republic	Novartis Investigative Site	Liberec V Kristianova
Czech Republic	Novartis Investigative Site	Melnik
Czech Republic	Novartis Investigative Site	Olomouc
Czech Republic	Novartis Investigative Site	Plzen
Czech Republic	Novartis Investigative Site	Prague 1
Czech Republic	Novartis Investigative Site	Prague 10, Vrsovice
Czech Republic	Novartis Investigative Site	Prague 5
Czech Republic	Novartis Investigative Site	Praha 2
Czech Republic	Novartis Investigative Site	Praha 2	CZE
Czech Republic	Novartis Investigative Site	Praha 4
Czech Republic	Novartis Investigative Site	Semily
Czech Republic	Novartis Investigative Site	Strakonice
Czech Republic	Novartis Investigative Site	Trebic
Czech Republic	Novartis Investigative Site	Uherske Hradiste
Czech Republic	Novartis Investigative Site	Uherske Hradiste
Czech Republic	Novartis Investigative Site	Usti nad Labem
Denmark	Novartis Investigative Site	Aarhus C
Denmark	Novartis Investigative Site	Copenhagen
Denmark	Novartis Investigative Site	Esbjerg
Denmark	Novartis Investigative Site	Hellerup
Denmark	Novartis Investigative Site	Herning
Denmark	Novartis Investigative Site	Randers NØ
Denmark	Novartis Investigative Site	Roskilde
Denmark	Novartis Investigative Site	Svendborg
Denmark	Novartis Investigative Site	Vejle
Denmark	Novartis Investigative Site	Viborg
Dominican Republic	Novartis Investigative Site	Santo Domingo	Republica Dominicana
Dominican Republic	Novartis Investigative Site	Santo Domingo
Ecuador	Novartis Investigative Site	Guayaquil	Guayas
Ecuador	Novartis Investigative Site	Guayaquil	Guayas
Ecuador	Novartis Investigative Site	Guayaquil	Guayas
Ecuador	Novartis Investigative Site	Quito	Pichincha
Estonia	Novartis Investigative Site	Haabneeme, Viimsi vald
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Finland	Novartis Investigative Site	HUS
Finland	Novartis Investigative Site	Kemi
Finland	Novartis Investigative Site	Kuopio
Finland	Novartis Investigative Site	Oulu
Finland	Novartis Investigative Site	Tampere
France	Novartis Investigative Site	Abbeville
France	Novartis Investigative Site	Bayonne
France	Novartis Investigative Site	Bayonne
France	Novartis Investigative Site	Beziers Cedex
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Caen
France	Novartis Investigative Site	Cholet
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Essey Les Nancy
France	Novartis Investigative Site	Grenoble
France	Novartis Investigative Site	Lagny sur Marne
France	Novartis Investigative Site	Langres
France	Novartis Investigative Site	Le Chesnay
France	Novartis Investigative Site	Le Plessis Robinson
France	Novartis Investigative Site	Limoges
France	Novartis Investigative Site	Lomme
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Nice Cedex 1
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris cedex 10
France	Novartis Investigative Site	Reims
France	Novartis Investigative Site	Rouen
France	Novartis Investigative Site	St Aubin Lès Elbeuf
France	Novartis Investigative Site	Strasbourg	Cedex
France	Novartis Investigative Site	Toulouse Cedex
France	Novartis Investigative Site	Tourcoing
France	Novartis Investigative Site	Valencienne
France	Novartis Investigative Site	Vandoeuvre les Nancy
Germany	Novartis Investigative Site	Ahrensfelde
Germany	Novartis Investigative Site	Bad Homburg
Germany	Novartis Investigative Site	Bad Krozingen
Germany	Novartis Investigative Site	Bad Salzuflen
Germany	Novartis Investigative Site	Bad Schwartau
Germany	Novartis Investigative Site	Barsinghausen
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	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin-Buch
Germany	Novartis Investigative Site	Bernau
Germany	Novartis Investigative Site	Bitburg
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Darmstadt
Germany	Novartis Investigative Site	Dessau-Roßlau
Germany	Novartis Investigative Site	Dietzenbach
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	Eilenburg
Germany	Novartis Investigative Site	Elsterwerda
Germany	Novartis Investigative Site	Erfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Georgsmarienhütte
Germany	Novartis Investigative Site	Giengen
Germany	Novartis Investigative Site	Goch
Germany	Novartis Investigative Site	Graben-Neudorf
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	Hamminkeln
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Homburg
Germany	Novartis Investigative Site	Hoppegarten-Dahlwitz
Germany	Novartis Investigative Site	Huy / OT Anderbeck
Germany	Novartis Investigative Site	Ingelheim
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Kallstadt
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kelkheim
Germany	Novartis Investigative Site	Koethen
Germany	Novartis Investigative Site	Künzelsau
Germany	Novartis Investigative Site	Langen
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Loehne
Germany	Novartis Investigative Site	Lübeck
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Lütjenburg
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Mannheim	Baden-Württemberg
Germany	Novartis Investigative Site	Meissen
Germany	Novartis Investigative Site	Meißen
Germany	Novartis Investigative Site	Mönchengladbach
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Mühldorf
Germany	Novartis Investigative Site	Mühlheim
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Münster
Germany	Novartis Investigative Site	Neunkirchen
Germany	Novartis Investigative Site	Neunkirchen
Germany	Novartis Investigative Site	Nienburg
Germany	Novartis Investigative Site	Offenbach
Germany	Novartis Investigative Site	Oldenburg i.H.
Germany	Novartis Investigative Site	Osnabrück
Germany	Novartis Investigative Site	Papenburg
Germany	Novartis Investigative Site	Rhaunen
Germany	Novartis Investigative Site	Riesa
Germany	Novartis Investigative Site	Rodgau
Germany	Novartis Investigative Site	Schenklengsfeld
Germany	Novartis Investigative Site	Schkeuditz
Germany	Novartis Investigative Site	Schwäbisch Hall
Germany	Novartis Investigative Site	St. Ingbert - Oberwuerzbach
Germany	Novartis Investigative Site	Unterschneidheim
Germany	Novartis Investigative Site	Wangen
Germany	Novartis Investigative Site	Wardenburg
Germany	Novartis Investigative Site	Weeze
Germany	Novartis Investigative Site	Wermsdorf
Germany	Novartis Investigative Site	Westhofen
Germany	Novartis Investigative Site	Wetzlar-Naunheim
Germany	Novartis Investigative Site	Weyhe
Germany	Novartis Investigative Site	Wolmirstedt
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Hong Kong	Novartis Investigative Site	Hong Kong
Hong Kong	Novartis Investigative Site	Hong Kong
Hong Kong	Novartis Investigative Site	Hong Kong SAR
Hungary	Novartis Investigative Site	Baja
Hungary	Novartis Investigative Site	Balatonfured
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	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	Cegled
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Eger
Hungary	Novartis Investigative Site	Hodmezovasarhely
Hungary	Novartis Investigative Site	Kaposvár
Hungary	Novartis Investigative Site	Miskolc
Hungary	Novartis Investigative Site	Nagykanizsa
Hungary	Novartis Investigative Site	Nyiregyháza
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Pecs	Baranya
Hungary	Novartis Investigative Site	Sopron
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szekesfehervar
Hungary	Novartis Investigative Site	Szekszard
Hungary	Novartis Investigative Site	Zalaegerszeg
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
India	Novartis Investigative Site	Anand	Gujarat
India	Novartis Investigative Site	Bangalore	Karnataka
India	Novartis Investigative Site	Bangalore	Karnataka
India	Novartis Investigative Site	Banglaore	Karnataka
India	Novartis Investigative Site	Bikaner	Rajasthan
India	Novartis Investigative Site	Chennai	Tamil Nadu
India	Novartis Investigative Site	Chennai	Tamil Nadu
India	Novartis Investigative Site	Cochin	Kerala
India	Novartis Investigative Site	Dehli	Delhi
India	Novartis Investigative Site	Guntur	Andhra Pradesh
India	Novartis Investigative Site	Gurgaon	Haryana
India	Novartis Investigative Site	Hyderabad
India	Novartis Investigative Site	Hyderabad	Andhra Pradesh
India	Novartis Investigative Site	Hyderabad	Andhra Pradesh
India	Novartis Investigative Site	Hyderabad	Andhra Pradesh, INDIA
India	Novartis Investigative Site	Indore
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Kota	Rajasthan
India	Novartis Investigative Site	Lucknow	Uttar Pradesh
India	Novartis Investigative Site	Ludhiana	Punjab
India	Novartis Investigative Site	Mangalore	Karnataka
India	Novartis Investigative Site	Mumbai	Maharashtra
India	Novartis Investigative Site	Mysore	Karnataka
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nashik	Maharashtra
India	Novartis Investigative Site	Nashik	Maharashtra
India	Novartis Investigative Site	Nashik	Maharashtra
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Rajkot	Gujrat
India	Novartis Investigative Site	Surat	Gujarat
India	Novartis Investigative Site	Tirupati	Andhra Pradesh
India	Novartis Investigative Site	Trivandrum	Kerala
India	Novartis Investigative Site	Trivandrum	Kerala
India	Novartis Investigative Site	Vadodara	Gujrat
India	Novartis Investigative Site	Varanasi	Uttar Pradesh
India	Novartis Investigative Site	Vishakhapatnam	Andhra Pradesh
India	Novartis Investigative Site	Vishakhapatnam	Andhra Pradesh
Israel	Novartis Investigative Site	Ashkelon
Israel	Novartis Investigative Site	Hadera
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Rehovot
Israel	Novartis Investigative Site	Safed
Italy	Novartis Investigative Site	Albano Laziale	RM
Italy	Novartis Investigative Site	Aosta	AO
Italy	Novartis Investigative Site	Battipaglia	SA
Italy	Novartis Investigative Site	Bergamo	BG
Italy	Novartis Investigative Site	Bolzano	BZ
Italy	Novartis Investigative Site	Casorate Primo	PV
Italy	Novartis Investigative Site	Catanzaro	CZ
Italy	Novartis Investigative Site	Cava De' Tirreni	SA
Italy	Novartis Investigative Site	Cona	FE
Italy	Novartis Investigative Site	Cortona	AR
Italy	Novartis Investigative Site	Cosenza	CS
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Lido di Camaiore	LU
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milazzo	ME
Italy	Novartis Investigative Site	Modena	MO
Italy	Novartis Investigative Site	Monza	MB
Italy	Novartis Investigative Site	Palmanova	UD
Italy	Novartis Investigative Site	Pavia	PV
Italy	Novartis Investigative Site	Perugia	PG
Italy	Novartis Investigative Site	Pescia	PT
Italy	Novartis Investigative Site	Piove di Sacco	PD
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Pozzilli	IS
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Salerno	SA
Italy	Novartis Investigative Site	San Daniele Del Friuli	UD
Italy	Novartis Investigative Site	San Pietro Vernotico	BR
Italy	Novartis Investigative Site	Sassari	SS
Italy	Novartis Investigative Site	Seriate	BG
Italy	Novartis Investigative Site	Stradella	PV
Italy	Novartis Investigative Site	Thiesi	SS
Italy	Novartis Investigative Site	Tradate	VA
Italy	Novartis Investigative Site	Treviglio	BG
Italy	Novartis Investigative Site	Varese	VA
Italy	Novartis Investigative Site	Vibo Valentia	VV
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	Gwangju
Korea, Republic of	Novartis Investigative Site	Pusan
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Suwon	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Wonju	Gangwon-Do
Latvia	Novartis Investigative Site	Daugavplis
Latvia	Novartis Investigative Site	Kuldiga
Latvia	Novartis Investigative Site	Liepaja	LV
Latvia	Novartis Investigative Site	Preili
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Ventspils
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Kedainiai
Lithuania	Novartis Investigative Site	Siauliai
Lithuania	Novartis Investigative Site	Vilnius
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Kuching	Sarawak
Malaysia	Novartis Investigative Site	Pulau Pinang	Penang
Mexico	Novartis Investigative Site	Aguascalientes
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Mexico	Novartis Investigative Site	México	Distrito Federal
Mexico	Novartis Investigative Site	Mexico City	Distrito Federal
Mexico	Novartis Investigative Site	Mexico D.F	Distrito Federal
Mexico	Novartis Investigative Site	Monterrey	Nuevo León
Mexico	Novartis Investigative Site	Queretaro
Mexico	Novartis Investigative Site	San Juan del Rio	Queretaro
Mexico	Novartis Investigative Site	San Luis Potosi
Mexico	Novartis Investigative Site	San Luis Potosí
Mexico	Novartis Investigative Site	San Luis Potosí
Mexico	Novartis Investigative Site	Zapopan	Jalisco
Netherlands	Novartis Investigative Site	Amersfoort
Netherlands	Novartis Investigative Site	Arnhem
Netherlands	Novartis Investigative Site	Blaricum
Netherlands	Novartis Investigative Site	Breda
Netherlands	Novartis Investigative Site	Delft
Netherlands	Novartis Investigative Site	Den Bosch
Netherlands	Novartis Investigative Site	Den Haag
Netherlands	Novartis Investigative Site	Ede
Netherlands	Novartis Investigative Site	Eindhoven
Netherlands	Novartis Investigative Site	Goes
Netherlands	Novartis Investigative Site	Gorinchem
Netherlands	Novartis Investigative Site	Hardenberg
Netherlands	Novartis Investigative Site	Harderwijk
Netherlands	Novartis Investigative Site	Heerenveen
Netherlands	Novartis Investigative Site	Hengelo
Netherlands	Novartis Investigative Site	Hoorn
Netherlands	Novartis Investigative Site	Maastricht
Netherlands	Novartis Investigative Site	Nijmegen
Netherlands	Novartis Investigative Site	Oss	NL
Netherlands	Novartis Investigative Site	Sneek
Netherlands	Novartis Investigative Site	Tilburg
Netherlands	Novartis Investigative Site	Veldhoven
Panama	Novartis Investigative Site	Panama City	Panamá
Panama	Novartis Investigative Site	Panama City	Panamá
Peru	Novartis Investigative Site	Arequipa
Peru	Novartis Investigative Site	Bellavista	Lima
Peru	Novartis Investigative Site	Cercado de Lima	Lima
Peru	Novartis Investigative Site	Jesus Maria	Lima
Peru	Novartis Investigative Site	La Molina	Lima
Peru	Novartis Investigative Site	San Borja	Lima
Peru	Novartis Investigative Site	San Isidro	Lima
Peru	Novartis Investigative Site	San Miguel	Lima
Philippines	Novartis Investigative Site	Bulacan
Philippines	Novartis Investigative Site	Lipa City	Batangas
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Pasig City
Philippines	Novartis Investigative Site	Quezon City
Philippines	Novartis Investigative Site	Quezon City
Philippines	Novartis Investigative Site	Quezon City	Manila
Philippines	Novartis Investigative Site	Quezon City	Metro Manila
Philippines	Novartis Investigative Site	San Juan City
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Gdynia
Poland	Novartis Investigative Site	Gdynia
Poland	Novartis Investigative Site	Gdynia
Poland	Novartis Investigative Site	Gdynia
Poland	Novartis Investigative Site	Gliwice
Poland	Novartis Investigative Site	Golub-Dobrzyn
Poland	Novartis Investigative Site	Katowice
Poland	Novartis Investigative Site	Katowice
Poland	Novartis Investigative Site	Katowice
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Kutno
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Lublin
Poland	Novartis Investigative Site	Olawa
Poland	Novartis Investigative Site	Skierniewice
Poland	Novartis Investigative Site	Wroclaw
Poland	Novartis Investigative Site	Wroclaw
Poland	Novartis Investigative Site	Wroclaw
Poland	Novartis Investigative Site	Zabrze
Portugal	Novartis Investigative Site	Amadora
Portugal	Novartis Investigative Site	Covilha
Portugal	Novartis Investigative Site	Guimarães
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Penafiel
Portugal	Novartis Investigative Site	Portalegre
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Setubal
Portugal	Novartis Investigative Site	Vila Real	Portuigal
Romania	Novartis Investigative Site	Arad
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest	District 1
Romania	Novartis Investigative Site	Bucharest	District 5
Romania	Novartis Investigative Site	Bucuresti	District 1
Romania	Novartis Investigative Site	Bucuresti	District 2
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Craiova	Jud. Dolj
Romania	Novartis Investigative Site	Craiova	Jud.Dolj
Romania	Novartis Investigative Site	Deva
Romania	Novartis Investigative Site	Pitesti
Romania	Novartis Investigative Site	Ploiesti	Jud.Prahova
Romania	Novartis Investigative Site	Timisoara	jud. Timis
Romania	Novartis Investigative Site	Timisoara
Romania	Novartis Investigative Site	Timisoara
Romania	Novartis Investigative Site	Timisoara
Romania	Novartis Investigative Site	Timisoara
Romania	Novartis Investigative Site	Timisoara
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Gatchina
Russian Federation	Novartis Investigative Site	Ivanovo
Russian Federation	Novartis Investigative Site	Izhevsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Kirov
Russian Federation	Novartis Investigative Site	Krasnodar
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	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	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	N. Novgorod
Russian Federation	Novartis Investigative Site	N.Novgorod
Russian Federation	Novartis Investigative Site	N.Novgorod
Russian Federation	Novartis Investigative Site	Nizhnii Novgorod
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Novosibirsk-117
Russian Federation	Novartis Investigative Site	Orenburg
Russian Federation	Novartis Investigative Site	Orenburg
Russian Federation	Novartis Investigative Site	Penza
Russian Federation	Novartis Investigative Site	Perm
Russian Federation	Novartis Investigative Site	Petrozavodsk
Russian Federation	Novartis Investigative Site	Rostov-on-Don
Russian Federation	Novartis Investigative Site	S-Petersburg
Russian Federation	Novartis Investigative Site	S.-Petersburg
Russian Federation	Novartis Investigative Site	S.-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	Sankt-Peterburg
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Smolensk
Russian Federation	Novartis Investigative Site	St-Peterburg
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	St.Petersburg
Russian Federation	Novartis Investigative Site	Syktyvkar
Russian Federation	Novartis Investigative Site	Tula
Russian Federation	Novartis Investigative Site	Tver
Russian Federation	Novartis Investigative Site	Vladimir
Russian Federation	Novartis Investigative Site	Volgograd
Russian Federation	Novartis Investigative Site	Voronezh
Russian Federation	Novartis Investigative Site	Yaroslavl
Russian Federation	Novartis Investigative Site	Yaroslavl
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Bratislava	Slovak Republic
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Brezno	Slovak Republic
Slovakia	Novartis Investigative Site	Dolny Kubin
Slovakia	Novartis Investigative Site	Dunajska Streda
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Kosice	Slovak Republic
Slovakia	Novartis Investigative Site	Kralovsky Chlmec
Slovakia	Novartis Investigative Site	Levice
Slovakia	Novartis Investigative Site	Levice
Slovakia	Novartis Investigative Site	Levice	Slovak Republic
Slovakia	Novartis Investigative Site	Lucenec
Slovakia	Novartis Investigative Site	Martin
Slovakia	Novartis Investigative Site	Nitra
Slovakia	Novartis Investigative Site	Presov	Slovak Republic
Slovakia	Novartis Investigative Site	Presov	Slovak Republic
Slovakia	Novartis Investigative Site	Svidnik	Slovak Republic
Slovakia	Novartis Investigative Site	Trnava
Slovakia	Novartis Investigative Site	Trnava
Slovakia	Novartis Investigative Site	Vranov nad Toplou	Slovak Republic
South Africa	Novartis Investigative Site	Alberton
South Africa	Novartis Investigative Site	Bloemfontein
South Africa	Novartis Investigative Site	Bloemfontein
South Africa	Novartis Investigative Site	Bloemfontein	Free State
South Africa	Novartis Investigative Site	Breyton
South Africa	Novartis Investigative Site	Brits
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Durban
South Africa	Novartis Investigative Site	Durban
South Africa	Novartis Investigative Site	Durban
South Africa	Novartis Investigative Site	East London
South Africa	Novartis Investigative Site	Gatesville
South Africa	Novartis Investigative Site	Johannesburg
South Africa	Novartis Investigative Site	Kempton Park
South Africa	Novartis Investigative Site	Middelburg	Mpumalanga
South Africa	Novartis Investigative Site	Mthatha	Eastern Cape
South Africa	Novartis Investigative Site	Paarl	Western Cape
South Africa	Novartis Investigative Site	Port Elizabeth
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Somerset West	Western Cape
South Africa	Novartis Investigative Site	Soweto	Gauteng
South Africa	Novartis Investigative Site	Umkomaas
South Africa	Novartis Investigative Site	Witbank
South Africa	Novartis Investigative Site	Worcester
Spain	Novartis Investigative Site	A Coruna	Galicia
Spain	Novartis Investigative Site	Alcala de Henares	Madrid
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Almeria	Andalucia
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	El Palmar	Murcia
Spain	Novartis Investigative Site	Ferrol	Galicia
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Majadahonda	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Mallorca	Islas Baleares
Spain	Novartis Investigative Site	Marbella	Andalucia
Spain	Novartis Investigative Site	Mérida	Extremadura
Spain	Novartis Investigative Site	Mostoles	Madrid
Spain	Novartis Investigative Site	Sant Joan Despi	Cataluna
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Vigo	Galicia
Sweden	Novartis Investigative Site	Göteborg
Sweden	Novartis Investigative Site	Göteborg
Sweden	Novartis Investigative Site	Härnösand
Sweden	Novartis Investigative Site	Helsingborg
Sweden	Novartis Investigative Site	Karlshamn
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Motala
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Vällingby
Taiwan	Novartis Investigative Site	Changhua
Taiwan	Novartis Investigative Site	Ilan
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Tainan 704	Taiwan ROC
Taiwan	Novartis Investigative Site	Taipei	Taiwan, ROC
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Khon Kaen
Thailand	Novartis Investigative Site	Muang
Thailand	Novartis Investigative Site	Muang
Thailand	Novartis Investigative Site	Taladkwan	Nonthaburi
Turkey	Novartis Investigative Site	Adana
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Antalya
Turkey	Novartis Investigative Site	Balcova / Izmir
Turkey	Novartis Investigative Site	Edirne
Turkey	Novartis Investigative Site	Etlik / Ankara
Turkey	Novartis Investigative Site	Haseki / Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Kocaeli
Turkey	Novartis Investigative Site	Mersin
Turkey	Novartis Investigative Site	Meselik / Eskisehir
Turkey	Novartis Investigative Site	Sivas
United Kingdom	Novartis Investigative Site	Basingstoke	Hampshire
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Blackpool
United Kingdom	Novartis Investigative Site	Bournemouth
United Kingdom	Novartis Investigative Site	Bradford
United Kingdom	Novartis Investigative Site	Brighton	East Sussex
United Kingdom	Novartis Investigative Site	Bristol	Bs2 8hw
United Kingdom	Novartis Investigative Site	Cambridge	Cambrigdeshire
United Kingdom	Novartis Investigative Site	Cheshire
United Kingdom	Novartis Investigative Site	Coventry
United Kingdom	Novartis Investigative Site	Craigavon	Northern Ireland
United Kingdom	Novartis Investigative Site	Croydon
United Kingdom	Novartis Investigative Site	Darlington
United Kingdom	Novartis Investigative Site	Dorchester	Dorset
United Kingdom	Novartis Investigative Site	Dudley	West Midlands
United Kingdom	Novartis Investigative Site	Dundee	Perthshire
United Kingdom	Novartis Investigative Site	Durham	County Durham
United Kingdom	Novartis Investigative Site	Exeter
United Kingdom	Novartis Investigative Site	Inverness
United Kingdom	Novartis Investigative Site	Kent
United Kingdom	Novartis Investigative Site	Leicester	Leicestershire
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Londonderry
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Middlesborough
United Kingdom	Novartis Investigative Site	Milton Keynes
United Kingdom	Novartis Investigative Site	Newport
United Kingdom	Novartis Investigative Site	Newport
United Kingdom	Novartis Investigative Site	Norwich
United Kingdom	Novartis Investigative Site	Oldham	Lancashire
United Kingdom	Novartis Investigative Site	Poole
United Kingdom	Novartis Investigative Site	Portsmouth	Hampshire
United Kingdom	Novartis Investigative Site	Redhill	Surrey
United Kingdom	Novartis Investigative Site	Romford	Essex
United Kingdom	Novartis Investigative Site	Rotherham
United Kingdom	Novartis Investigative Site	Royal Bridge Wells	Kent
United Kingdom	Novartis Investigative Site	Sheffield	South Yorkshire
United Kingdom	Novartis Investigative Site	South Shields	Tyne and Wear
United Kingdom	Novartis Investigative Site	Stevenage
United Kingdom	Novartis Investigative Site	Sunderland
United Kingdom	Novartis Investigative Site	Surrey
United Kingdom	Novartis Investigative Site	Sutton Coldfield	West Midlands
United Kingdom	Novartis Investigative Site	Swansea	England
United Kingdom	Novartis Investigative Site	Taunton	Somerset
United Kingdom	Novartis Investigative Site	Vale of Glamorgan
United Kingdom	Novartis Investigative Site	Worcester
United Kingdom	Novartis Investigative Site	Yeovil	Somerset
United Kingdom	Novartis Investigative Site	York
United States	Novartis Investigative Site	Albuquerque	New Mexico
United States	Novartis Investigative Site	Alexandria	Louisiana
United States	Novartis Investigative Site	Aliquippa	Pennsylvania
United States	Novartis Investigative Site	Amarillo	Texas
United States	Novartis Investigative Site	Anaheim	California
United States	Novartis Investigative Site	Anchorage	Alaska
United States	Novartis Investigative Site	Ann Arbor	Michigan
United States	Novartis Investigative Site	Arlington	Texas
United States	Novartis Investigative Site	Asheboro	North Carolina
United States	Novartis Investigative Site	Asheville	North Carolina
United States	Novartis Investigative Site	Ayer	Massachusetts
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Bartlesville	Oklahoma
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	Bellflower	California
United States	Novartis Investigative Site	Beltsville	Maryland
United States	Novartis Investigative Site	Berkley	California
United States	Novartis Investigative Site	Biddeford	Maine
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Boynton Beach	Florida
United States	Novartis Investigative Site	Brownsville	Texas
United States	Novartis Investigative Site	Cadiz	Ohio
United States	Novartis Investigative Site	Canton	Ohio
United States	Novartis Investigative Site	Cary	North Carolina
United States	Novartis Investigative Site	Charleston	South Carolina
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	Cleveland	Ohio
United States	Novartis Investigative Site	Columbia	Maryland
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Cordtlandt Manor	New York
United States	Novartis Investigative Site	Covington	Louisiana
United States	Novartis Investigative Site	Covington	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	Dallas	Texas
United States	Novartis Investigative Site	Davie	Florida
United States	Novartis Investigative Site	Decatur	Georgia
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Des Moines	Iowa
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Elizabeth	New Jersey
United States	Novartis Investigative Site	Fort Lauderdale	Florida
United States	Novartis Investigative Site	Fredericksburg	Virginia
United States	Novartis Investigative Site	Fremont	Nebraska
United States	Novartis Investigative Site	Gainesville	Florida
United States	Novartis Investigative Site	Gilbert	Arizona
United States	Novartis Investigative Site	Grand Island	Nebraska
United States	Novartis Investigative Site	Grapevine	Texas
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Hamilton	New Jersey
United States	Novartis Investigative Site	Haverhill	Massachusetts
United States	Novartis Investigative Site	Honolulu	Hawaii
United States	Novartis Investigative Site	Honolulu	Hawaii
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	Huntsville	Alabama
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	Kingwood	Texas
United States	Novartis Investigative Site	Lafayette	Louisiana
United States	Novartis Investigative Site	Lakeland	Florida
United States	Novartis Investigative Site	Lapeer	Michigan
United States	Novartis Investigative Site	Laurelton	New York
United States	Novartis Investigative Site	Layton	Utah
United States	Novartis Investigative Site	Leesburg	Florida
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Livingston	Texas
United States	Novartis Investigative Site	Loma Linda	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Lufkin	Texas
United States	Novartis Investigative Site	Madison	Wisconsin
United States	Novartis Investigative Site	Marion	Ohio
United States	Novartis Investigative Site	Mather	California
United States	Novartis Investigative Site	Maywood	Illinois
United States	Novartis Investigative Site	Melrose Park	Illinois
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Milwaukee	Wisconsin
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Mobile	Alabama
United States	Novartis Investigative Site	Muscle Shoals	Alabama
United States	Novartis Investigative Site	Nashua	New Hampshire
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	Natick	Massachusetts
United States	Novartis Investigative Site	New Brunswick	New Jersey
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Newark	New Jersey
United States	Novartis Investigative Site	Northport	New York
United States	Novartis Investigative Site	Nottingham	Maryland
United States	Novartis Investigative Site	Ocean	New Jersey
United States	Novartis Investigative Site	Oceanside	California
United States	Novartis Investigative Site	Odessa	Texas
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Palm Springs	California
United States	Novartis Investigative Site	Park Ridge	Illinois
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Picayune	Mississippi
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Plano	Texas
United States	Novartis Investigative Site	Pomona	California
United States	Novartis Investigative Site	Port Charlotte	Florida
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Pratt	Kansas
United States	Novartis Investigative Site	Quincy	Illinois
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	Rapid City	South Dakota
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Rolling Fork	Mississippi
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Saginaw	Michigan
United States	Novartis Investigative Site	San Diego	California
* Note: There are 1030 locations in all - only the first 1000 are shown.

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czech Republic,  Denmark,  Dominican Republic,  Ecuador,  Estonia,  Finland,  France,  Germany,  Guatemala,  Hong Kong,  Hungary,  Iceland,  India,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  Panama,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization	Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.	up to 51 months	No
Secondary	Number of Patients - All-cause Mortality	Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure HF patients this measures how many patients had this event. The data is on FAS population up to March 31, 2014	up to 51 months	Yes
Secondary	Number of Patients Reported With Adjudicated Primary Causes of Death	Number of patients reported with adjudicated primary causes of death. The data is on Randomization population up to March 31, 2014	up to 51 months	Yes
Secondary	Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score	Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	Baseline, Month 8	No
Secondary	Number of Patients With First Confirmed Renal Dysfunction	Number of patients with first confirmed renal dysfunction	up to 51 months	No
Secondary	Percentage of Participants With New Onset of Atrial Fibrillation (AF)	Percentage of participants with New Onset of Atrial Fibrillation The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).	up to 51 months	No