Clinical trial NCT02226120: Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction
Official title: A Multicenter Study to Evaluate Safety and Tolerability in Patients With Chronic Heart Failure and Reduced Ejection Fraction From PARADIGM-HF Receiving Open Label LCZ696
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Heart Failure With Reduced Ejection Fraction
Keywords: LCZ696
chronic heart failure
ARNI
Congestive heart failure (CHF)
heart failure (HF)
acute heart failure syndrome
congestive cardiac failure (CCF)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-08-27
Enrollment: 1980
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent for the extension must be obtained before any assessment is performed.
2. Patients who have completed PARADIGM-HF (protocol CLCZ696B2314) and are able to be safely enrolled into the open-label trial as judged by the investigator.

Exclusion Criteria:

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
2. 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 LCZ696
3. Known history of angioedema
4. Requirement of simultaneous treatment with both ACEIs and ARBs
5. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
6. Symptomatic hypotension and/or a SBP \< 100 mmHg at Visit 1 (screening)
7. Estimated GFR \< 30 mL/min/1.73m\^2 as measured by the simplified MDRD formula at Visit 1 (screening)
8. Presence of bilateral renal artery stenosis
9. Serum potassium \> 5.2 mmol/L at Visit 1 (screening)
10. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
11. Pregnant or nursing (lactating) women
12. Women of child-bearing potential
13. Any condition, not identified in the protocol, that in the opinion of the investigator is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the study.

Primary outcomes:
measure: Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696
timeFrame: From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Muscle Shoals
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Little Rock
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Oceanside
country: United States
facility: Novartis Investigative Site
state: California
city: Palm Springs
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Santa Rosa
country: United States
facility: Novartis Investigative Site
state: California
city: Boynton Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Des Moines
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Covington
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Columbia
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Saginaw
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Fremont
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Rosedale
country: United States
facility: Novartis Investigative Site
state: New York
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Marion
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Rapid City
country: United States
facility: Novartis Investigative Site
state: South Dakota
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Livingston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Spokane
country: United States
facility: Novartis Investigative Site
state: Washington
city: Waukesha
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Capital Federal
city: San Salvador de Jujuy
country: Argentina
facility: Novartis Investigative Site
state: Jujuy
city: Ciudad de Salta
country: Argentina
facility: Novartis Investigative Site
state: Provincia De Salta
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Corrientes
country: Argentina
facility: Novartis Investigative Site
city: Formosa
country: Argentina
facility: Novartis Investigative Site
city: Formosa
country: Argentina
facility: Novartis Investigative Site
city: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: San Luis
country: Argentina
facility: Novartis Investigative Site
city: Santa Fe
country: Argentina
facility: Novartis Investigative Site
city: Santa Fe
country: Argentina
facility: Novartis Investigative Site
city: Santiago del Estero
country: Argentina
facility: Novartis Investigative Site
city: Brasschaat
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: La Louviere
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Ronse
country: Belgium
facility: Novartis Investigative Site
city: Salvador
country: Brazil
facility: Novartis Investigative Site
state: BA
city: Brasilia
country: Brazil
facility: Novartis Investigative Site
state: DF
city: Goiania
country: Brazil
facility: Novartis Investigative Site
state: GO
city: Goiania
country: Brazil
facility: Novartis Investigative Site
state: GO
city: Goiania
country: Brazil
facility: Novartis Investigative Site
state: GO
city: Sao Luis
country: Brazil
facility: Novartis Investigative Site
state: MA
city: Uberlandia
country: Brazil
facility: Novartis Investigative Site
state: Mg-cep
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Belem
country: Brazil
facility: Novartis Investigative Site
state: PA
city: Recife
country: Brazil
facility: Novartis Investigative Site
state: PE
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Marilia
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Ribeirao Preto
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Santo Andre
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Jose do Rio Preto
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Votuporanga
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Haskovo
country: Bulgaria
facility: Novartis Investigative Site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Shumen
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Victoria
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Kitchener
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Weston
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Levis
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: St-Georges Beauce
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Temuco
country: Chile
facility: Novartis Investigative Site
state: Araucania
city: Beroun
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Brandys nad Labem
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Liberec V Kristianova
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Olomouc
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Prague 10, Vrsovice
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Trebic
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Bilovec
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Kolin
country: Czechia
facility: Novartis Investigative Site
city: Prague 5
country: Czechia
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
city: Uherske Hradiste
country: Czechia
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Esbjerg
country: Denmark
facility: Novartis Investigative Site
city: Hellerup
country: Denmark
facility: Novartis Investigative Site
city: Randers
country: Denmark
facility: Novartis Investigative Site
city: Svendborg
country: Denmark
facility: Novartis Investigative Site
city: Vejle
country: Denmark
facility: Novartis Investigative Site
city: Viborg
country: Denmark
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Tampere
country: Finland
facility: Novartis Investigative Site
city: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
state: Herault
city: Paris
country: France
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Bad Homburg
country: Germany
facility: Novartis Investigative Site
city: Bad Krozingen
country: Germany
facility: Novartis Investigative Site
city: Berlin-Buch
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dessau-Roßlau
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Elsterwerda
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Huy / OT Anderbeck
country: Germany
facility: Novartis Investigative Site
city: Ingelheim
country: Germany
facility: Novartis Investigative Site
city: Kelkheim
country: Germany
facility: Novartis Investigative Site
city: Koethen
country: Germany
facility: Novartis Investigative Site
city: Künzelsau
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Loehne
country: Germany
facility: Novartis Investigative Site
city: Muehldorf
country: Germany
facility: Novartis Investigative Site
city: Muehlheim An Der Ruhr
country: Germany
facility: Novartis Investigative Site
city: Offenbach
country: Germany
facility: Novartis Investigative Site
city: Wermsdorf
country: Germany
facility: Novartis Investigative Site
city: Wetzlar-Naunheim
country: Germany
facility: Novartis Investigative Site
city: Weyhe
country: Germany
facility: Novartis Investigative Site
city: Guatemala
country: Guatemala
facility: Novartis Investigative Site
state: Ciudad
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Hong Kong SAR
country: Hong Kong
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Nyiregyháza
country: Hungary
facility: Novartis Investigative Site
city: Szekesfehervar
country: Hungary
facility: Novartis Investigative Site
city: Szekszard
country: Hungary
facility: Novartis Investigative Site
city: Zalaegerszeg
country: Hungary
facility: Novartis Investigative Site
city: Guntur
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Dehli
country: India
facility: Novartis Investigative Site
state: Delhi
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Anand
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Surat
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Surat
country: India
facility: Novartis Investigative Site
state: Gujrat
city: Vadodara
country: India
facility: Novartis Investigative Site
state: Gujrat
city: Mumbai
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Ludhiana
country: India
facility: Novartis Investigative Site
state: Punjab
city: Bikaner
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Telangana
city: Indore
country: India
facility: Novartis Investigative Site
city: Ashkelon
country: Israel
facility: Novartis Investigative Site
city: Hadera
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Safed
country: Israel
facility: Novartis Investigative Site
city: Aosta
country: Italy
facility: Novartis Investigative Site
state: AO
city: Cortona
country: Italy
facility: Novartis Investigative Site
state: AR
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: Treviglio
country: Italy
facility: Novartis Investigative Site
state: BG
city: Cosenza
country: Italy
facility: Novartis Investigative Site
state: CS
city: Cona
country: Italy
facility: Novartis Investigative Site
state: FE
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Pozzilli
country: Italy
facility: Novartis Investigative Site
state: IS
city: Lido di Camaiore
country: Italy
facility: Novartis Investigative Site
state: LU
city: Milazzo
country: Italy
facility: Novartis Investigative Site
state: ME
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Pescia
country: Italy
facility: Novartis Investigative Site
state: Point
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Ariccia
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Salerno
country: Italy
facility: Novartis Investigative Site
state: SA
city: Sassari
country: Italy
facility: Novartis Investigative Site
state: SS
city: Wonju
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gangwon-Do
city: Suwon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seocho-gu
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
city: Ventspils
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Kedainiai
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: San Juan del Rio
country: Mexico
facility: Novartis Investigative Site
state: Queretaro
city: Aguascalientes
country: Mexico
facility: Novartis Investigative Site
city: San Luis Potosi
country: Mexico
facility: Novartis Investigative Site
city: San Luis Potosí
country: Mexico
facility: Novartis Investigative Site
city: Breda
country: Netherlands
facility: Novartis Investigative Site
state: CK
city: Amersfoort
country: Netherlands
facility: Novartis Investigative Site
city: Arnhem
country: Netherlands
facility: Novartis Investigative Site
city: Blaricum
country: Netherlands
facility: Novartis Investigative Site
city: Delft
country: Netherlands
facility: Novartis Investigative Site
city: Den Bosch
country: Netherlands
facility: Novartis Investigative Site
city: Ede
country: Netherlands
facility: Novartis Investigative Site
city: Gorinchem
country: Netherlands
facility: Novartis Investigative Site
city: Hardenberg
country: Netherlands
facility: Novartis Investigative Site
city: Harderwijk
country: Netherlands
facility: Novartis Investigative Site
city: Heerenveen
country: Netherlands
facility: Novartis Investigative Site
city: Hengelo
country: Netherlands
facility: Novartis Investigative Site
city: Sneek
country: Netherlands
facility: Novartis Investigative Site
city: Tilburg
country: Netherlands
facility: Novartis Investigative Site
city: Veldhoven
country: Netherlands
facility: Novartis Investigative Site
city: Panama City
country: Panama
facility: Novartis Investigative Site
city: Panama City
country: Panama
facility: Novartis Investigative Site
city: Bellavista
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Jesus Maria
country: Peru
facility: Novartis Investigative Site
state: Lima
city: La Molina
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Borja
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Isidro
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Miguel
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Arequipa
country: Peru
facility: Novartis Investigative Site
city: Lipa City
country: Philippines
facility: Novartis Investigative Site
state: Batangas
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
state: Manila
city: Pasig City
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Gdynia
country: Poland
facility: Novartis Investigative Site
city: Gdynia
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Vila Real
country: Portugal
facility: Novartis Investigative Site
state: Portuigal
city: Covilha
country: Portugal
facility: Novartis Investigative Site
city: Guimaraes
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Portalegre
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Setubal
country: Portugal
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: Jud. Dolj
city: Timisoara
country: Romania
facility: Novartis Investigative Site
state: Timis
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Craiova
country: Romania
facility: Novartis Investigative Site
city: Deva
country: Romania
facility: Novartis Investigative Site
city: Timisoara
country: Romania
facility: Novartis Investigative Site
city: Timisoara
country: Romania
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ivanovo
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Kemerovo
country: Russian Federation
facility: Novartis Investigative Site
city: Kirov
country: Russian Federation
facility: Novartis Investigative Site
city: Krasnodar
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: N. Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: N.Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhnii Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk-117
country: Russian Federation
facility: Novartis Investigative Site
city: Orenburg
country: Russian Federation
facility: Novartis Investigative Site
city: Orenburg
country: Russian Federation
facility: Novartis Investigative Site
city: Perm
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov-on-Don
country: Russian Federation
facility: Novartis Investigative Site
city: S-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
country: Russian Federation
facility: Novartis Investigative Site
city: St-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Tula
country: Russian Federation
facility: Novartis Investigative Site
city: Vladimir
country: Russian Federation
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Brezno
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Levice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Presov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Svidnik
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Lucenec
country: Slovakia
facility: Novartis Investigative Site
city: Martin
country: Slovakia
facility: Novartis Investigative Site
city: Bloemfontein
country: South Africa
facility: Novartis Investigative Site
state: Free State
city: Soweto
country: South Africa
facility: Novartis Investigative Site
state: Gauteng
city: Durban
country: South Africa
facility: Novartis Investigative Site
state: Kwa-Zulu Natal
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
state: Western Cape
city: Alberton
country: South Africa
facility: Novartis Investigative Site
city: Bloemfontein
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Durban
country: South Africa
facility: Novartis Investigative Site
city: Johannesburg
country: South Africa
facility: Novartis Investigative Site
city: Kempton Park
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Worcester
country: South Africa
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Marbella
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sant Joan Despi
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: A Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Vigo
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Alcala de Henares
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Mostoles
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
state: SE
city: Goteborg
country: Sweden
facility: Novartis Investigative Site
city: Göteborg
country: Sweden
facility: Novartis Investigative Site
city: Karlshamn
country: Sweden
facility: Novartis Investigative Site
city: Motala
country: Sweden
facility: Novartis Investigative Site
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Yilan
country: Taiwan
facility: Novartis Investigative Site
city: Taladkwan
country: Thailand
facility: Novartis Investigative Site
state: Nonthaburi
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Muang
country: Thailand
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kocaeli
country: Turkey
facility: Novartis Investigative Site
city: Sivas
country: Turkey
facility: Novartis Investigative Site
city: Durham
country: United Kingdom
facility: Novartis Investigative Site
state: County Durham
city: Dorchester
country: United Kingdom
facility: Novartis Investigative Site
state: Dorset
city: Basingstoke
country: United Kingdom
facility: Novartis Investigative Site
state: Hampshire
city: Portsmouth
country: United Kingdom
facility: Novartis Investigative Site
state: Hampshire
city: Inverness
country: United Kingdom
facility: Novartis Investigative Site
state: Invernesshire
city: Oldham
country: United Kingdom
facility: Novartis Investigative Site
state: Lancashire
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
state: Leicestershire
city: Craigavon
country: United Kingdom
facility: Novartis Investigative Site
state: Northern Ireland
city: Dundee
country: United Kingdom
facility: Novartis Investigative Site
state: Perthshire
city: Taunton
country: United Kingdom
facility: Novartis Investigative Site
state: Somerset
city: Yeovil
country: United Kingdom
facility: Novartis Investigative Site
state: Somerset
city: Sheffield
country: United Kingdom
facility: Novartis Investigative Site
state: South Yorkshire
city: Redhill
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: South Shields
country: United Kingdom
facility: Novartis Investigative Site
state: Tyne And Wear
city: Sunderland
country: United Kingdom
facility: Novartis Investigative Site
state: Tyne And Wear
city: Dudley
country: United Kingdom
facility: Novartis Investigative Site
state: West Midlands
city: Cheshire
country: United Kingdom
facility: Novartis Investigative Site
city: Coventry
country: United Kingdom
facility: Novartis Investigative Site
city: Exeter
country: United Kingdom
facility: Novartis Investigative Site
city: Kent
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Milton Keynes
country: United Kingdom
facility: Novartis Investigative Site
city: Newport
country: United Kingdom
facility: Novartis Investigative Site
city: Newport
country: United Kingdom
facility: Novartis Investigative Site
city: Norwich
country: United Kingdom
facility: Novartis Investigative Site
city: Poole
country: United Kingdom
facility: Novartis Investigative Site
city: Rotherham
country: United Kingdom
facility: Novartis Investigative Site
city: Worcester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: