Clinical trial NCT01920711: Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: Heart failure
preserved ejection fraction
diastolic heart failure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-08-12
Enrollment: 4822
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

Detailed description: This was a multicenter, randomized, double-blind, parallel group, active-controlled, study to evaluate the efficacy and safety of sacubitril/valsartan compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction. Specifically, the study evaluated the effect of sacubitril/valsartan compared to the active comparator valsartan in the reduction of the rate of CV death and total HF hospitalizations in patients with HFpEF. The trial consisted of two periods: (1) a single-blind treatment run-in epoch that lasted from 3 to 8 weeks, in which patients received valsartan 80 mg bid, followed by sacubitril/valsartan 100 mg bid and (2) a double-blind randomized treatment epoch (sacubitril/valsartan 200 mg bid or valsartan 160 mg bid). In this study, investigators were responsible for assessing and submitting all events which could potentially fulfill the criteria for the primary, secondary, or other clinical endpoints to a Clinical Endpoint Committee (CEC). Investigator reported events were assessed by the CEC for adjudication.

For angioedema or angioedema-like events, investigators completed an Adjudication Questionnaire for an Angioedema-like Event form. All angioedema reports were forwarded to an Angioedema Adjudication Committee (AAC) by Novartis for assessment.

Eligibility criteria: Inclusion Criteria:

* Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or within 6 months prior to study entry.
* Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry.
* Current symptom(s) of HF (NYHA class II-IV)
* Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
* Elevated NT-proBNP

Exclusion Criteria:

* Any prior measurement of LVEF \< 40%.
* Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry.
* Any clinical event within the 6 months prior to entry could have reduced the LVEF (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF ≥45%.
* Current acute decompensated HF requiring therapy.
* Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor.
* Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) \<10 g/dl, or body mass index (BMI) \> 40 kg/m2.
* Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP \>150 mmHg and \<180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP \< 110 mmHg at entry.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations.
timeFrame: Total follow up time (up to 57 months)
Secondary outcomes:
measure: Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline, 8 months
measure: Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class
timeFrame: Baseline, 8 months
measure: Participants With First Occurrence of a Composite Renal Endpoint
timeFrame: Randomization to total follow-up time (up to 57 months)
measure: All-cause Mortality
timeFrame: Randomization to total follow up time (up to 57 months)
Other outcomes:
Locations:
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country: United States
facility: Novartis Investigative Site
state: Alabama
city: Mobile
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facility: Novartis Investigative Site
state: Alabama
city: Muscle Shoals
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city: Little Rock
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city: Kingston
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city: Northport
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city: Rochester
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city: Saratoga Springs
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city: Chapel Hill
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city: Marion
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city: Yardley
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city: Rapid City
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state: South Dakota
city: Sioux Falls
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city: Memphis
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city: Nashville
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city: Nashville
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city: Beaumont
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state: Texas
city: Dallas
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city: Houston
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city: Livingston
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city: McKinney
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city: Salt Lake City
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state: Utah
city: Salt Lake City
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state: Utah
city: White River Junction
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state: Vermont
city: Seattle
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state: Washington
city: Seattle
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city: Madison
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state: Wisconsin
city: Madison
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state: Wisconsin
city: Milwaukee
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city: Caba
country: Argentina
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state: Buenos Aires
city: Caba
country: Argentina
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state: Buenos Aires
city: Caba
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facility: Novartis Investigative Site
state: Buenos Aires
city: Quilmes
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state: Buenos Aires
city: Ramos Mejia
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state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Capital Federal
city: Posadas
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facility: Novartis Investigative Site
state: Misiones
city: Ciudad de Salta
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facility: Novartis Investigative Site
state: Provincia De Salta
city: Tucuman
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state: San Miguel De Tucuman
city: Rosario
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state: Santa Fe
city: Rosario
country: Argentina
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state: Santa Fe
city: Rosario
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state: Santa Fe
city: Rosario
country: Argentina
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state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
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state: Tucuman
city: Buenos Aires
country: Argentina
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city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Caba
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
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city: Cordoba
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city: Cordoba
country: Argentina
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city: Cordoba
country: Argentina
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city: Cordoba
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facility: Novartis Investigative Site
city: Formosa
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city: San Luis
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city: Santa Fe
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facility: Novartis Investigative Site
city: Southport
country: Australia
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state: Queensland
city: Bedford Park
country: Australia
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state: South Australia
city: Bundoora
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state: Victoria
city: Epping
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state: Victoria
city: Geelong
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state: Victoria
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
state: Tyrol
city: Braunau
country: Austria
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Großgmain
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Aalst
country: Belgium
facility: Novartis Investigative Site
city: Antwerpen
country: Belgium
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city: Brasschaat
country: Belgium
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city: Bruxelles
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city: De Pinte
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city: Genk
country: Belgium
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city: Gent
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city: Hasselt
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city: Huy
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city: Kortrijk
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facility: Novartis Investigative Site
city: Leuven
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city: Ottignies
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city: Goiania
country: Brazil
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state: GO
city: Belo Horizonte
country: Brazil
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state: MG
city: Uberlandia
country: Brazil
facility: Novartis Investigative Site
state: Minas Gerais
city: Curitiba
country: Brazil
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state: Parana
city: Campina Grande do Sul
country: Brazil
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state: PR
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Liberdade
country: Brazil
facility: Novartis Investigative Site
state: Sao Paulo
city: Blumenau
country: Brazil
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state: SC
city: Campinas
country: Brazil
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state: SP
city: Campinas
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Ribeirao Preto
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Jose do Rio Preto
country: Brazil
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state: SP
city: Sao Paulo
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state: SP
city: Burgas
country: Bulgaria
facility: Novartis Investigative Site
city: Pazardzhik
country: Bulgaria
facility: Novartis Investigative Site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
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city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Shumen
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facility: Novartis Investigative Site
city: Silistra
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city: Sliven
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city: Smolian
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city: Sofia
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city: Sofia
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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
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city: Sofia
country: Bulgaria
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city: Sofia
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facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Veliko Tarnovo
country: Bulgaria
facility: Novartis Investigative Site
city: Calgary
country: Canada
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state: Alberta
city: Victoria
country: Canada
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state: British Columbia
city: St. John
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: Halifax
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state: Nova Scotia
city: Cambridge
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
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facility: Novartis Investigative Site
state: Ontario
city: Weston
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
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: Sainte Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
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state: Quebec
city: Thetford Mines
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Trois Rivieres
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Chongqing
country: China
facility: Novartis Investigative Site
state: Chongqing
city: Lanzhou
country: China
facility: Novartis Investigative Site
state: Gansu
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Nanning
country: China
facility: Novartis Investigative Site
state: Guangxi
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Suzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Wuxi
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanchang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Changchun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Jilin
country: China
facility: Novartis Investigative Site
state: Jilin
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Xi'an
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Xian
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Tianjin
country: China
facility: Novartis Investigative Site
state: Tianjin
city: Wulumuqi
country: China
facility: Novartis Investigative Site
state: Xinjiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Jinan
country: China
facility: Novartis Investigative Site
city: Nanjing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Medellin
country: Colombia
facility: Novartis Investigative Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
state: Atlantico
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Florida Blanca
country: Colombia
facility: Novartis Investigative Site
city: Varazdin
country: Croatia
facility: Novartis Investigative Site
state: HRV
city: Rijeka
country: Croatia
facility: Novartis Investigative Site
city: Zadar
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Brandys nad Labem
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Brno
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Ivancice
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Kladno
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Liberec
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Louny
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Ostrava
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Plzen
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Praha 4
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Roznov pod Radhostem
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Svitavy
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Trebic
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Usti nad Labem
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Znojmo
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Policska
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Praha 2
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Usti nad Labem
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: CZE
country: Czechia
facility: Novartis Investigative Site
city: Kolin
country: Czechia
facility: Novartis Investigative Site
city: Marianske lazne
country: Czechia
facility: Novartis Investigative Site
city: Uherske Hradiste
country: Czechia
facility: Novartis Investigative Site
city: Esbjerg
country: Denmark
facility: Novartis Investigative Site
city: Glostrup
country: Denmark
facility: Novartis Investigative Site
city: Herlev
country: Denmark
facility: Novartis Investigative Site
city: Hvidovre
country: Denmark
facility: Novartis Investigative Site
city: Randers
country: Denmark
facility: Novartis Investigative Site
city: Svendborg
country: Denmark
facility: Novartis Investigative Site
city: Viborg
country: Denmark
facility: Novartis Investigative Site
city: Jyvaskyla
country: Finland
facility: Novartis Investigative Site
city: Oulu
country: Finland
facility: Novartis Investigative Site
city: Tampere
country: Finland
facility: Novartis Investigative Site
city: Bayonne
country: France
facility: Novartis Investigative Site
state: Bayonne Cedex
city: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
state: Herault
city: Besancon Cedex
country: France
facility: Novartis Investigative Site
city: Beziers Cedex
country: France
facility: Novartis Investigative Site
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Grenoble
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Paris cedex 10
country: France
facility: Novartis Investigative Site
city: Poitiers
country: France
facility: Novartis Investigative Site
city: Pontoise
country: France
facility: Novartis Investigative Site
city: Rennes Cedex 9
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex
country: France
facility: Novartis Investigative Site
city: Tourcoing
country: France
facility: Novartis Investigative Site
city: Vandoeuvre Les Nancy
country: France
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Bad Homburg
country: Germany
facility: Novartis Investigative Site
city: Bad Krozingen
country: Germany
facility: Novartis Investigative Site
city: Bamberg
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: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
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: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duisburg
country: Germany
facility: Novartis Investigative Site
city: Eilenburg
country: Germany
facility: Novartis Investigative Site
city: Elsterwerda
country: Germany
facility: Novartis Investigative Site
city: Essen
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: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hassloch
country: Germany
facility: Novartis Investigative Site
city: Heidenau
country: Germany
facility: Novartis Investigative Site
city: Heppenheim
country: Germany
facility: Novartis Investigative Site
city: Homburg
country: Germany
facility: Novartis Investigative Site
city: Ingelheim
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Kleve
country: Germany
facility: Novartis Investigative Site
city: Koblenz
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Loehne
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Lutherstadt Wittenberg
country: Germany
facility: Novartis Investigative Site
city: Lüneburg
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Meißen
country: Germany
facility: Novartis Investigative Site
city: Memmingen
country: Germany
facility: Novartis Investigative Site
city: Muehldorf Am Inn
country: Germany
facility: Novartis Investigative Site
city: Muehldorf
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Munich
country: Germany
facility: Novartis Investigative Site
city: Nienburg
country: Germany
facility: Novartis Investigative Site
city: Northeim
country: Germany
facility: Novartis Investigative Site
city: Oschatz
country: Germany
facility: Novartis Investigative Site
city: Papenburg
country: Germany
facility: Novartis Investigative Site
city: Reinfeld
country: Germany
facility: Novartis Investigative Site
city: Riesa
country: Germany
facility: Novartis Investigative Site
city: Rodgau
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Wermsdorf
country: Germany
facility: Novartis Investigative Site
city: Weyhe
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
state: Attica
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Ioannina
country: Greece
facility: Novartis Investigative Site
state: GR
city: Larissa
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Zalaegerszeg
country: Hungary
facility: Novartis Investigative Site
state: Zala
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: Cegled
country: Hungary
facility: Novartis Investigative Site
city: Kistarcsa
country: Hungary
facility: Novartis Investigative Site
city: Mako
country: Hungary
facility: Novartis Investigative Site
city: Nyiregyháza
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Pécs
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Szekesfehervar
country: Hungary
facility: Novartis Investigative Site
city: Guntur
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Vishakhapatnam
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Surat
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Chandigarh
country: India
facility: Novartis Investigative Site
state: Haryana
city: Gurgaon
country: India
facility: Novartis Investigative Site
state: Haryana
city: Kochi
country: India
facility: Novartis Investigative Site
state: Kerala
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: Chennai
country: India
facility: Novartis Investigative Site
state: Tamil NADU
city: Chennai
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Madurai
country: India
facility: Novartis Investigative Site
state: Tamil NADU
city: Kolkata
country: India
facility: Novartis Investigative Site
state: West Bengal
city: New Delhi
country: India
facility: Novartis Investigative Site
city: Hadera
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: Lower Galilee
country: Israel
facility: Novartis Investigative Site
city: Nahariya
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Tel Giborim, Holon
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: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: BS
city: Cona
country: Italy
facility: Novartis Investigative Site
state: FE
city: Pozzilli
country: Italy
facility: Novartis Investigative Site
state: IS
city: Monza
country: Italy
facility: Novartis Investigative Site
state: MB
city: Messina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Vimercate
country: Italy
facility: Novartis Investigative Site
state: MI
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: PG
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: PG
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: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Sassari
country: Italy
facility: Novartis Investigative Site
state: SS
city: Trieste
country: Italy
facility: Novartis Investigative Site
state: TS
city: Trieste
country: Italy
facility: Novartis Investigative Site
state: TS
city: Palmanova
country: Italy
facility: Novartis Investigative Site
state: UD
city: San Daniele Del Friuli
country: Italy
facility: Novartis Investigative Site
state: UD
city: Saronno
country: Italy
facility: Novartis Investigative Site
state: Va
city: Venezia
country: Italy
facility: Novartis Investigative Site
state: VE
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Seto-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Chikushino-city
country: Japan
facility: Novartis Investigative Site
state: Fukuka
city: Ogaki-city
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Maebashi city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Amagasaki city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kanazawa
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Morioka
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Kanonji-city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Takamatsu city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Kashihara city
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Sayama-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kusatsu city
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Gyeonggi do
country: Korea, Republic of
facility: Novartis Investigative Site
state: Bucheon Si
city: Cheongju si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Chungcheongbuk Do
city: Wonju
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gangwon-do
city: Bundang Gu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
state: KOR
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: KOR
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: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Torreon
country: Mexico
facility: Novartis Investigative Site
state: Coahulia
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Leon
country: Mexico
facility: Novartis Investigative Site
state: Guanajuato
city: Zapopan
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: San Juan del Rio
country: Mexico
facility: Novartis Investigative Site
state: Queretaro
city: San Luis Potosi
country: Mexico
facility: Novartis Investigative Site
state: San Luis Potosí
city: Culiacan
country: Mexico
facility: Novartis Investigative Site
state: Sinaloa
city: Aguascalientes
country: Mexico
facility: Novartis Investigative Site
city: Queretaro
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: Apeldoorn
country: Netherlands
facility: Novartis Investigative Site
state: DZ
city: Den Haag
country: Netherlands
facility: Novartis Investigative Site
state: NL
city: Almelo
country: Netherlands
facility: Novartis Investigative Site
state: PP
city: Arnhem
country: Netherlands
facility: Novartis Investigative Site
city: Blaricum
country: Netherlands
facility: Novartis Investigative Site
city: Den Haag
country: Netherlands
facility: Novartis Investigative Site
city: Ede
country: Netherlands
facility: Novartis Investigative Site
city: Gouda
country: Netherlands
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Hardenberg
country: Netherlands
facility: Novartis Investigative Site
city: Harderwijk
country: Netherlands
facility: Novartis Investigative Site
city: Nijmegen
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Sneek
country: Netherlands
facility: Novartis Investigative Site
city: Tilburg
country: Netherlands
facility: Novartis Investigative Site
city: Loerenskog
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Stavanger
country: Norway
facility: Novartis Investigative Site
city: Tromsoe
country: Norway
facility: Novartis Investigative Site
city: Bellavista
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Cercado De Lima
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Jesus Maria
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Miraflores
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Isidro
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Lipa City
country: Philippines
facility: Novartis Investigative Site
state: Batangas
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
state: Manila
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
state: Lodzkie
city: Gdynia
country: Poland
facility: Novartis Investigative Site
city: Gdynia
country: Poland
facility: Novartis Investigative Site
city: Grodzisk Mazowiecki
country: Poland
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Sandomierz
country: Poland
facility: Novartis Investigative Site
city: Staszów
country: Poland
facility: Novartis Investigative Site
city: Torun
country: Poland
facility: Novartis Investigative Site
city: Warszawa/Anin
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Zabrze
country: Poland
facility: Novartis Investigative Site
city: Zamosc
country: Poland
facility: Novartis Investigative Site
city: Pitesti
country: Romania
facility: Novartis Investigative Site
state: Arges
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: Jud. Dolj
city: Sibiu
country: Romania
facility: Novartis Investigative Site
state: Jud. Iasi
city: Timisoara
country: Romania
facility: Novartis Investigative Site
state: Timis
city: Timisoara
country: Romania
facility: Novartis Investigative Site
state: Timis
city: Arad
country: Romania
facility: Novartis Investigative Site
city: Baia Mare
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Targu Mures
country: Romania
facility: Novartis Investigative Site
city: Targu Mures
country: Romania
facility: Novartis Investigative Site
city: Timisoara
country: Romania
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ivanovo
country: Russian Federation
facility: Novartis Investigative Site
city: Izhevsk
country: Russian Federation
facility: Novartis Investigative Site
city: Izhevsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kemerovo
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: Kirov
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: Perm
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov on Don
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov-on-Don
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: Sestroretsk
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: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Belgrade
country: Serbia
facility: Novartis Investigative Site
city: Beograd
country: Serbia
facility: Novartis Investigative Site
city: Niska Banja
country: Serbia
facility: Novartis Investigative Site
city: Nis
country: Serbia
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
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: Komarno
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Levice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Namestovo
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Povazska Bystrica
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Presov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
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: 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: Levice
country: Slovakia
facility: Novartis Investigative Site
city: Lucenec
country: Slovakia
facility: Novartis Investigative Site
city: Lucenec
country: Slovakia
facility: Novartis Investigative Site
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
city: Nove Zamky
country: Slovakia
facility: Novartis Investigative Site
city: Nove Zamky
country: Slovakia
facility: Novartis Investigative Site
city: Piestany
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Svidnik
country: Slovakia
facility: Novartis Investigative Site
city: Trebisov
country: Slovakia
facility: Novartis Investigative Site
city: Zilina
country: Slovakia
facility: Novartis Investigative Site
city: Golnik
country: Slovenia
facility: Novartis Investigative Site
city: Ljubljana
country: Slovenia
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: 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: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Durban
country: South Africa
facility: Novartis Investigative Site
city: Tongaat
country: South Africa
facility: Novartis Investigative Site
city: Western Cape
country: South Africa
facility: Novartis Investigative Site
city: Worcester
country: South Africa
facility: Novartis Investigative Site
city: Almeria
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Marbella
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sanlúcar de Barrameda
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
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: Barcelona
city: Villamartin
country: Spain
facility: Novartis Investigative Site
state: Cadiz
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Aranda de Duero
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Leon
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Lerida
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Alzira
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Merida
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: A Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Olot
country: Spain
facility: Novartis Investigative Site
state: Girona
city: Mostoles
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: El Palmar
country: Spain
facility: Novartis Investigative Site
state: Murcia
city: Ciudad Real
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Danderyd
country: Sweden
facility: Novartis Investigative Site
city: Falun
country: Sweden
facility: Novartis Investigative Site
city: Goteborg
country: Sweden
facility: Novartis Investigative Site
city: Karlstad
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Orebro
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Vasteras
country: Sweden
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Biel
country: Switzerland
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan ROC
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: New Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
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: Istanbul
country: Turkey
facility: Novartis Investigative Site
state: TUR
city: Haydarpasa 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: Pendik / Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Sivas
country: Turkey
facility: Novartis Investigative Site
city: High Wycombe
country: United Kingdom
facility: Novartis Investigative Site
state: Buckinghamshire
city: Stockton on Tees
country: United Kingdom
facility: Novartis Investigative Site
state: Cleveland
city: Darlington
country: United Kingdom
facility: Novartis Investigative Site
state: Co Durham
city: Durham
country: United Kingdom
facility: Novartis Investigative Site
state: County Durham
city: Torquay
country: United Kingdom
facility: Novartis Investigative Site
state: Devon
city: Dorchester
country: United Kingdom
facility: Novartis Investigative Site
state: Dorset
city: Peterborough
country: United Kingdom
facility: Novartis Investigative Site
state: GBR
city: Basingstoke
country: United Kingdom
facility: Novartis Investigative Site
state: Hampshire
city: Portsmouth
country: United Kingdom
facility: Novartis Investigative Site
state: Hampshire
city: Oldham
country: United Kingdom
facility: Novartis Investigative Site
state: Lancashire
city: Harrow
country: United Kingdom
facility: Novartis Investigative Site
state: Middlesex
city: Portadown
country: United Kingdom
facility: Novartis Investigative Site
state: Nothern Ireland
city: Wansford
country: United Kingdom
facility: Novartis Investigative Site
state: Peterborough
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
state: Scotland
city: Taunton
country: United Kingdom
facility: Novartis Investigative Site
state: Somerset
city: Gateshead
country: United Kingdom
facility: Novartis Investigative Site
state: Tyne And Wear
city: Clydebank
country: United Kingdom
facility: Novartis Investigative Site
state: West Dumbartonshire
city: Cheshire
country: United Kingdom
facility: Novartis Investigative Site
city: Coventry
country: United Kingdom
facility: Novartis Investigative Site
city: Dundee
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Hull
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Newport
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Sheffield
country: United Kingdom
facility: Novartis Investigative Site
city: Swindon
country: United Kingdom
facility: Novartis Investigative Site
city: Wiltshire
country: United Kingdom
facility: Novartis Investigative Site
city: Wrexham
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Butt JH, Dewan P, Jhund PS, Anand IS, Atar D, Ge J, Desai AS, Echeverria LE, Kober L, Lam CSP, Maggioni AP, Martinez F, Packer M, Rouleau JL, Sim D, Van Veldhuisen DJ, Vrtovec B, Zannad F, Zile MR, Gong J, Lefkowitz MP, Rizkala AR, Solomon SD, McMurray JJV. Sacubitril/Valsartan and Frailty in Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2022 Sep 20;80(12):1130-1143. doi: 10.1016/j.jacc.2022.06.037. Epub 2022 Aug 29.
citation: Wijkman MO, Claggett B, Vaduganathan M, Cunningham JW, Rorth R, Jackson A, Packer M, Zile M, Rouleau J, Swedberg K, Lefkowitz M, Shah SJ, Pfeffer MA, McMurray JJV, Solomon SD. Effects of sacubitril/valsartan on glycemia in patients with diabetes and heart failure: the PARAGON-HF and PARADIGM-HF trials. Cardiovasc Diabetol. 2022 Jun 18;21(1):110. doi: 10.1186/s12933-022-01545-1.
citation: Vaduganathan M, Claggett BL, Inciardi RM, Fonarow GC, McMurray JJV, Solomon SD. Estimating the Benefits of Combination Medical Therapy in Heart Failure With Mildly Reduced and Preserved Ejection Fraction. Circulation. 2022 Jun 7;145(23):1741-1743. doi: 10.1161/CIRCULATIONAHA.121.058929. Epub 2022 May 23. No abstract available.
citation: Vaduganathan M, Claggett BL, McMurray JJV, Solomon SD. Health Status Trajectories Before and After Hospitalization for Heart Failure. Circulation. 2022 Jun 21;145(25):1872-1874. doi: 10.1161/CIRCULATIONAHA.122.059282. Epub 2022 May 21. No abstract available.
citation: Cikes M, Planinc I, Claggett B, Cunningham J, Milicic D, Sweitzer N, Senni M, Gori M, Linssen G, Shah SJ, Packer M, Pfeffer M, Zile MR, Anand I, Chiang LM, Lam CSP, Redfield M, Desai AS, McMurray JJV, Solomon SD. Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2022 May;10(5):336-346. doi: 10.1016/j.jchf.2022.01.018. Epub 2022 Apr 6.
citation: Jackson AM, Rorth R, Liu J, Kristensen SL, Anand IS, Claggett BL, Cleland JGF, Chopra VK, Desai AS, Ge J, Gong J, Lam CSP, Lefkowitz MP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rizkala AR, Rouleau JL, Seferovic PM, Tromp J, Van Veldhuisen DJ, Yilmaz MB, Zannad F, Zile MR, Kober L, Petrie MC, Jhund PS, Solomon SD, McMurray JJV; PARAGON-HF Committees and Investigators. Diabetes and pre-diabetes in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2022 Mar;24(3):497-509. doi: 10.1002/ejhf.2403. Epub 2022 Jan 4.
citation: Desai AS, Vaduganathan M, Cleland JG, Claggett BL, Barkoudah E, Finn P, McCausland FR, Yilmaz MB, Lefkowitz M, Shi V, Pfeffer MA, McMurray JJV, Solomon SD. Mode of Death in Patients With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF Trial. Circ Heart Fail. 2021 Dec;14(12):e008597. doi: 10.1161/CIRCHEARTFAILURE.121.008597. Epub 2021 Nov 22.
citation: Mooney L, Hawkins NM, Jhund PS, Redfield MM, Vaduganathan M, Desai AS, Rouleau JL, Minamisawa M, Shah AM, Lefkowitz MP, Zile MR, Van Veldhuisen DJ, Pfeffer MA, Anand IS, Maggioni AP, Senni M, Claggett BL, Solomon SD, McMurray JJV. Impact of Chronic Obstructive Pulmonary Disease in Patients With Heart Failure With Preserved Ejection Fraction: Insights From PARAGON-HF. J Am Heart Assoc. 2021 Dec 7;10(23):e021494. doi: 10.1161/JAHA.121.021494. Epub 2021 Nov 19.
citation: Jackson AM, Jhund PS, Anand IS, Dungen HD, Lam CSP, Lefkowitz MP, Linssen G, Lund LH, Maggioni AP, Pfeffer MA, Rouleau JL, Saraiva JFK, Senni M, Vardeny O, Wijkman MO, Yilmaz MB, Saito Y, Zile MR, Solomon SD, McMurray JJV. Sacubitril-valsartan as a treatment for apparent resistant hypertension in patients with heart failure and preserved ejection fraction. Eur Heart J. 2021 Sep 21;42(36):3741-3752. doi: 10.1093/eurheartj/ehab499.
citation: Felker GM, Butler J, Januzzi JL Jr, Desai AS, McMurray JJV, Solomon SD. Probabilistic Readjudication of Heart Failure Hospitalization Events in the PARAGON-HF Study. Circulation. 2021 Jun 8;143(23):2316-2318. doi: 10.1161/CIRCULATIONAHA.121.054496. Epub 2021 Jun 7. No abstract available.
citation: Selvaraj S, Claggett BL, Packer M, Zannad F, Anand IS, Pieske B, Zhao Z, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on Serum Lipids in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2021 Sep 7;10(17):e022069. doi: 10.1161/JAHA.121.022069. Epub 2021 May 16.
citation: Shen L, Jhund PS, Anand IS, Bhatt AS, Desai AS, Maggioni AP, Martinez FA, Pfeffer MA, Rizkala AR, Rouleau JL, Swedberg K, Vaduganathan M, Vardeny O, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Solomon SD, McMurray JJV. Incidence and Outcomes of Pneumonia in Patients With Heart Failure. J Am Coll Cardiol. 2021 Apr 27;77(16):1961-1973. doi: 10.1016/j.jacc.2021.03.001.
citation: Tromp J, Claggett BL, Liu J, Jackson AM, Jhund PS, Kober L, Widimsky J, Boytsov SA, Chopra VK, Anand IS, Ge J, Chen CH, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Rizkala AR, Inubushi-Molessa A, Lefkowitz MP, Shi VC, McMurray JJV, Solomon SD, Lam CSP; PARAGON-HF Investigators. Global Differences in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. Circ Heart Fail. 2021 Apr;14(4):e007901. doi: 10.1161/CIRCHEARTFAILURE.120.007901. Epub 2021 Apr 19.
citation: Vaduganathan M, Cunningham JW, Claggett BL, Causland FM, Barkoudah E, Finn P, Zannad F, Pfeffer MA, Rizkala AR, Sabarwal S, McMurray JJV, Solomon S, Desai AS. Worsening Heart Failure Episodes Outside a Hospital Setting in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2021 May;9(5):374-382. doi: 10.1016/j.jchf.2021.01.014. Epub 2021 Apr 7.
citation: Gronda E, Vanoli E, Iacoviello M. The PARAGON-HF trial: the sacubitril/valsartan in heart failure with preserved ejection fraction. Eur Heart J Suppl. 2020 Nov 18;22(Suppl L):L77-L81. doi: 10.1093/eurheartj/suaa140. eCollection 2020 Nov.
citation: Jering K, Claggett B, Redfield MM, Shah SJ, Anand IS, Martinez F, Sabarwal SV, Seferovic PM, Kerr Saraiva JF, Katova T, Lefkowitz MP, Pfeffer MA, McMurray JJV, Solomon SD. Burden of Heart Failure Signs and Symptoms, Prognosis, and Response to Therapy: The PARAGON-HF Trial. JACC Heart Fail. 2021 May;9(5):386-397. doi: 10.1016/j.jchf.2021.01.011. Epub 2021 Mar 10.
citation: Jering KS, Zannad F, Claggett B, Mc Causland FR, Ferreira JP, Desai A, Barkoudah E, McMurray JJV, Pfeffer MA, Solomon SD. Cardiovascular and Renal Outcomes of Mineralocorticoid Receptor Antagonist Use in PARAGON-HF. JACC Heart Fail. 2021 Jan;9(1):13-24. doi: 10.1016/j.jchf.2020.08.014. Epub 2020 Nov 11.
citation: Mc Causland FR, Lefkowitz MP, Claggett B, Anavekar NS, Senni M, Gori M, Jhund PS, McGrath MM, Packer M, Shi V, Van Veldhuisen DJ, Zannad F, Comin-Colet J, Pfeffer MA, McMurray JJV, Solomon SD. Angiotensin-Neprilysin Inhibition and Renal Outcomes in Heart Failure With Preserved Ejection Fraction. Circulation. 2020 Sep 29;142(13):1236-1245. doi: 10.1161/CIRCULATIONAHA.120.047643. Epub 2020 Aug 17.
citation: Cunningham JW, Claggett BL, O'Meara E, Prescott MF, Pfeffer MA, Shah SJ, Redfield MM, Zannad F, Chiang LM, Rizkala AR, Shi VC, Lefkowitz MP, Rouleau J, McMurray JJV, Solomon SD, Zile MR. Effect of Sacubitril/Valsartan on Biomarkers of Extracellular Matrix Regulation in Patients With HFpEF. J Am Coll Cardiol. 2020 Aug 4;76(5):503-514. doi: 10.1016/j.jacc.2020.05.072.
citation: Cunningham JW, Vaduganathan M, Claggett BL, Zile MR, Anand IS, Packer M, Zannad F, Lam CSP, Janssens S, Jhund PS, Kober L, Rouleau J, Shah SJ, Chopra VK, Shi VC, Lefkowitz MP, Prescott MF, Pfeffer MA, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on N-Terminal Pro-B-Type Natriuretic Peptide in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2020 May;8(5):372-381. doi: 10.1016/j.jchf.2020.03.002. Epub 2020 Mar 30.
citation: Selvaraj S, Claggett BL, Bohm M, Anker SD, Vaduganathan M, Zannad F, Pieske B, Lam CSP, Anand IS, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Systolic Blood Pressure in Heart Failure With Preserved Ejection Fraction Treated With Sacubitril/Valsartan. J Am Coll Cardiol. 2020 Apr 14;75(14):1644-1656. doi: 10.1016/j.jacc.2020.02.009. Epub 2020 Mar 16.
citation: Shah AM, Cikes M, Prasad N, Li G, Getchevski S, Claggett B, Rizkala A, Lukashevich I, O'Meara E, Ryan JJ, Shah SJ, Mullens W, Zile MR, Lam CSP, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Echocardiographic Features of Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction. J Am Coll Cardiol. 2019 Dec 10;74(23):2858-2873. doi: 10.1016/j.jacc.2019.09.063.
citation: Solomon SD, Vaduganathan M, L Claggett B, Packer M, Zile M, Swedberg K, Rouleau J, A Pfeffer M, Desai A, Lund LH, Kober L, Anand I, Sweitzer N, Linssen G, Merkely B, Luis Arango J, Vinereanu D, Chen CH, Senni M, Sibulo A, Boytsov S, Shi V, Rizkala A, Lefkowitz M, McMurray JJV. Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure. Circulation. 2020 Feb 4;141(5):352-361. doi: 10.1161/CIRCULATIONAHA.119.044586. Epub 2019 Nov 17.
citation: McMurray JJV, Jackson AM, Lam CSP, Redfield MM, Anand IS, Ge J, Lefkowitz MP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Rizkala AR, Sabarwal SV, Shah AM, Shah SJ, Shi VC, van Veldhuisen DJ, Zannad F, Zile MR, Cikes M, Goncalvesova E, Katova T, Kosztin A, Lelonek M, Sweitzer N, Vardeny O, Claggett B, Jhund PS, Solomon SD. Effects of Sacubitril-Valsartan Versus Valsartan in Women Compared With Men With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF. Circulation. 2020 Feb 4;141(5):338-351. doi: 10.1161/CIRCULATIONAHA.119.044491. Epub 2019 Nov 17.
citation: Vaduganathan M, Claggett BL, Desai AS, Anker SD, Perrone SV, Janssens S, Milicic D, Arango JL, Packer M, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Prior Heart Failure Hospitalization, Clinical Outcomes, and Response to Sacubitril/Valsartan Compared With Valsartan in HFpEF. J Am Coll Cardiol. 2020 Jan 28;75(3):245-254. doi: 10.1016/j.jacc.2019.11.003. Epub 2019 Nov 11.
citation: Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.
citation: Chandra A, Vaduganathan M, Lewis EF, Claggett BL, Rizkala AR, Wang W, Lefkowitz MP, Shi VC, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2019 Oct;7(10):862-874. doi: 10.1016/j.jchf.2019.05.015. Epub 2019 Jul 10.
citation: Solomon SD, Rizkala AR, Lefkowitz MP, Shi VC, Gong J, Anavekar N, Anker SD, Arango JL, Arenas JL, Atar D, Ben-Gal T, Boytsov SA, Chen CH, Chopra VK, Cleland J, Comin-Colet J, Duengen HD, Echeverria Correa LE, Filippatos G, Flammer AJ, Galinier M, Godoy A, Goncalvesova E, Janssens S, Katova T, Kober L, Lelonek M, Linssen G, Lund LH, O'Meara E, Merkely B, Milicic D, Oh BH, Perrone SV, Ranjith N, Saito Y, Saraiva JF, Shah S, Seferovic PM, Senni M, Sibulo AS Jr, Sim D, Sweitzer NK, Taurio J, Vinereanu D, Vrtovec B, Widimsky J Jr, Yilmaz MB, Zhou J, Zweiker R, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV. Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial. Circ Heart Fail. 2018 Jul;11(7):e004962. doi: 10.1161/CIRCHEARTFAILURE.118.004962.
citation: Mutze T, Glimm E, Schmidli H, Friede T. Group sequential designs with robust semiparametric recurrent event models. Stat Methods Med Res. 2019 Aug;28(8):2385-2403. doi: 10.1177/0962280218780538. Epub 2018 Jun 11.
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