Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05030428




Registration number
NCT05030428
Ethics application status
Date submitted
17/08/2021
Date registered
1/09/2021

Titles & IDs
Public title
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
Scientific title
A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT)
Secondary ID [1] 0 0
CKJX839B12302
Universal Trial Number (UTN)
Trial acronym
VICTORION-2P
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Inclisiran sodium 300 mg
Treatment: Drugs - Placebo

Experimental: Inclisiran sodium - Subcutaneous injection

Placebo comparator: Placebo - Subcutaneous injection


Treatment: Drugs: Inclisiran sodium 300 mg
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit

Treatment: Drugs: Placebo
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events)
Timepoint [1] 0 0
From randomization to total follow-up time (up to 72 months)
Secondary outcome [1] 0 0
Time to Occurrence of Cardiovascular (CV) Death
Timepoint [1] 0 0
From randomization to total follow-up time (up to 72 months)
Secondary outcome [2] 0 0
Time to First Occurrence of 4P-MACE (4-Point Major Adverse Cardiovascular Events)
Timepoint [2] 0 0
From randomization to total follow-up time (up to 72 months)
Secondary outcome [3] 0 0
Time to first occurrence of Major Limb Adverse Events (MALE)
Timepoint [3] 0 0
From randomization to total follow-up time (up to 72 months)
Secondary outcome [4] 0 0
Time to occurrence of all-cause death
Timepoint [4] 0 0
From randomization to total follow-up time (up to 72 months)

Eligibility
Key inclusion criteria
1. Fasting LDL-C = 70 mg/dL at randomization visit
2. Stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD
3. Established CV disease defined as ANY of the following three conditions

1. Spontaneous Myocardial infarction = 4 weeks from screening visit
2. History of ischemic stroke occurred = 4 weeks prior to the Screening visit
3. Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) < 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 4 weeks before screening visit
2. Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit
3. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit
4. Heart failure NYHA class III or IV
5. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver
6. Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years
7. Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years
8. History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit
9. Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/10/2027
Actual
Sample size
Target
Accrual to date
Final
17006
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Botany
Recruitment hospital [2] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [3] 0 0
Novartis Investigative Site - New Lambton Heights
Recruitment hospital [4] 0 0
Novartis Investigative Site - Auchenflower
Recruitment hospital [5] 0 0
Novartis Investigative Site - Bundaberg West
Recruitment hospital [6] 0 0
Novartis Investigative Site - Milton
Recruitment hospital [7] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [8] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [9] 0 0
Novartis Investigative Site - Bedford Park
Recruitment hospital [10] 0 0
Novartis Investigative Site - Leabrook
Recruitment hospital [11] 0 0
Novartis Investigative Site - Woodville
Recruitment hospital [12] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [13] 0 0
Novartis Investigative Site - Geelong
Recruitment hospital [14] 0 0
Novartis Investigative Site - Malvern East
Recruitment hospital [15] 0 0
Novartis Investigative Site - Murdoch
Recruitment hospital [16] 0 0
Novartis Investigative Site - Nedlands
Recruitment hospital [17] 0 0
Novartis Investigative Site - Richmond
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
4670 - Bundaberg West
Recruitment postcode(s) [6] 0 0
4064 - Milton
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
5068 - Leabrook
Recruitment postcode(s) [11] 0 0
5011 - Woodville
Recruitment postcode(s) [12] 0 0
3168 - Clayton
Recruitment postcode(s) [13] 0 0
3220 - Geelong
Recruitment postcode(s) [14] 0 0
3145 - Malvern East
Recruitment postcode(s) [15] 0 0
6150 - Murdoch
Recruitment postcode(s) [16] 0 0
6009 - Nedlands
Recruitment postcode(s) [17] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Connecticut
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Idaho
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
Country [13] 0 0
United States of America
State/province [13] 0 0
Indiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Iowa
Country [15] 0 0
United States of America
State/province [15] 0 0
Kansas
Country [16] 0 0
United States of America
State/province [16] 0 0
Kentucky
Country [17] 0 0
United States of America
State/province [17] 0 0
Louisiana
Country [18] 0 0
United States of America
State/province [18] 0 0
Maryland
Country [19] 0 0
United States of America
State/province [19] 0 0
Massachusetts
Country [20] 0 0
United States of America
State/province [20] 0 0
Michigan
Country [21] 0 0
United States of America
State/province [21] 0 0
Minnesota
Country [22] 0 0
United States of America
State/province [22] 0 0
Mississippi
Country [23] 0 0
United States of America
State/province [23] 0 0
Missouri
Country [24] 0 0
United States of America
State/province [24] 0 0
Nebraska
Country [25] 0 0
United States of America
State/province [25] 0 0
Nevada
Country [26] 0 0
United States of America
State/province [26] 0 0
New Hampshire
Country [27] 0 0
United States of America
State/province [27] 0 0
New Jersey
Country [28] 0 0
United States of America
State/province [28] 0 0
New Mexico
Country [29] 0 0
United States of America
State/province [29] 0 0
New York
Country [30] 0 0
United States of America
State/province [30] 0 0
North Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
North Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Ohio
Country [33] 0 0
United States of America
State/province [33] 0 0
Oklahoma
Country [34] 0 0
United States of America
State/province [34] 0 0
Oregon
Country [35] 0 0
United States of America
State/province [35] 0 0
Pennsylvania
Country [36] 0 0
United States of America
State/province [36] 0 0
Rhode Island
Country [37] 0 0
United States of America
State/province [37] 0 0
South Carolina
Country [38] 0 0
United States of America
State/province [38] 0 0
South Dakota
Country [39] 0 0
United States of America
State/province [39] 0 0
Tennessee
Country [40] 0 0
United States of America
State/province [40] 0 0
Texas
Country [41] 0 0
United States of America
State/province [41] 0 0
Utah
Country [42] 0 0
United States of America
State/province [42] 0 0
Virginia
Country [43] 0 0
United States of America
State/province [43] 0 0
Washington
Country [44] 0 0
Argentina
State/province [44] 0 0
Buenos Aires
Country [45] 0 0
Argentina
State/province [45] 0 0
Misiones
Country [46] 0 0
Argentina
State/province [46] 0 0
Provincia De Salta
Country [47] 0 0
Argentina
State/province [47] 0 0
San Miguel De Tucuman
Country [48] 0 0
Argentina
State/province [48] 0 0
Santa Fe
Country [49] 0 0
Argentina
State/province [49] 0 0
Tucuman
Country [50] 0 0
Argentina
State/province [50] 0 0
Ciudad de Buenos Aires
Country [51] 0 0
Argentina
State/province [51] 0 0
Cordoba
Country [52] 0 0
Argentina
State/province [52] 0 0
Corrientes
Country [53] 0 0
Argentina
State/province [53] 0 0
Formosa
Country [54] 0 0
Argentina
State/province [54] 0 0
Mendoza
Country [55] 0 0
Austria
State/province [55] 0 0
Braunau
Country [56] 0 0
Austria
State/province [56] 0 0
Graz
Country [57] 0 0
Belgium
State/province [57] 0 0
Antwerpen
Country [58] 0 0
Belgium
State/province [58] 0 0
Brasschaat
Country [59] 0 0
Belgium
State/province [59] 0 0
Brugge
Country [60] 0 0
Belgium
State/province [60] 0 0
Bruxelles
Country [61] 0 0
Belgium
State/province [61] 0 0
Charleroi
Country [62] 0 0
Belgium
State/province [62] 0 0
Edegem
Country [63] 0 0
Belgium
State/province [63] 0 0
Genk
Country [64] 0 0
Belgium
State/province [64] 0 0
Gent
Country [65] 0 0
Belgium
State/province [65] 0 0
Kortrijk
Country [66] 0 0
Belgium
State/province [66] 0 0
La Louviere
Country [67] 0 0
Belgium
State/province [67] 0 0
Roeselare
Country [68] 0 0
Belgium
State/province [68] 0 0
Ronse
Country [69] 0 0
Belgium
State/province [69] 0 0
Yvoir
Country [70] 0 0
Brazil
State/province [70] 0 0
AL
Country [71] 0 0
Brazil
State/province [71] 0 0
BA
Country [72] 0 0
Brazil
State/province [72] 0 0
DF
Country [73] 0 0
Brazil
State/province [73] 0 0
ES
Country [74] 0 0
Brazil
State/province [74] 0 0
MG
Country [75] 0 0
Brazil
State/province [75] 0 0
Minas Gerais
Country [76] 0 0
Brazil
State/province [76] 0 0
PR
Country [77] 0 0
Brazil
State/province [77] 0 0
RS
Country [78] 0 0
Brazil
State/province [78] 0 0
Santa Catarina
Country [79] 0 0
Brazil
State/province [79] 0 0
Sao Paulo
Country [80] 0 0
Brazil
State/province [80] 0 0
SE
Country [81] 0 0
Brazil
State/province [81] 0 0
SP
Country [82] 0 0
Brazil
State/province [82] 0 0
Campinas
Country [83] 0 0
Brazil
State/province [83] 0 0
Rio de Janeiro
Country [84] 0 0
Brazil
State/province [84] 0 0
Sao Jose
Country [85] 0 0
Bulgaria
State/province [85] 0 0
Blagoevgrad
Country [86] 0 0
Bulgaria
State/province [86] 0 0
Burgas
Country [87] 0 0
Bulgaria
State/province [87] 0 0
Haskovo
Country [88] 0 0
Bulgaria
State/province [88] 0 0
Kyustendil
Country [89] 0 0
Bulgaria
State/province [89] 0 0
Montana
Country [90] 0 0
Bulgaria
State/province [90] 0 0
Pernik
Country [91] 0 0
Bulgaria
State/province [91] 0 0
Pleven
Country [92] 0 0
Bulgaria
State/province [92] 0 0
Plovdiv
Country [93] 0 0
Bulgaria
State/province [93] 0 0
Ruse
Country [94] 0 0
Bulgaria
State/province [94] 0 0
Sliven
Country [95] 0 0
Bulgaria
State/province [95] 0 0
Sofia
Country [96] 0 0
Bulgaria
State/province [96] 0 0
Stamboliyski
Country [97] 0 0
Bulgaria
State/province [97] 0 0
Stara Zagora
Country [98] 0 0
Bulgaria
State/province [98] 0 0
Veliko Tarnovo
Country [99] 0 0
Canada
State/province [99] 0 0
Alberta
Country [100] 0 0
Canada
State/province [100] 0 0
British Columbia
Country [101] 0 0
Canada
State/province [101] 0 0
Manitoba
Country [102] 0 0
Canada
State/province [102] 0 0
New Brunswick
Country [103] 0 0
Canada
State/province [103] 0 0
Nova Scotia
Country [104] 0 0
Canada
State/province [104] 0 0
Ontario
Country [105] 0 0
Canada
State/province [105] 0 0
Quebec
Country [106] 0 0
Chile
State/province [106] 0 0
Araucania
Country [107] 0 0
Chile
State/province [107] 0 0
Los Lagos
Country [108] 0 0
Chile
State/province [108] 0 0
Region De Coquimbo
Country [109] 0 0
Chile
State/province [109] 0 0
Region De La Araucania
Country [110] 0 0
Chile
State/province [110] 0 0
Region Metropolitana
Country [111] 0 0
Chile
State/province [111] 0 0
RM
Country [112] 0 0
Chile
State/province [112] 0 0
Valparaiso
Country [113] 0 0
Chile
State/province [113] 0 0
Santiago
Country [114] 0 0
China
State/province [114] 0 0
Chongqing
Country [115] 0 0
China
State/province [115] 0 0
Guangdong
Country [116] 0 0
China
State/province [116] 0 0
Guangxi
Country [117] 0 0
China
State/province [117] 0 0
Heilongjiang
Country [118] 0 0
China
State/province [118] 0 0
Hubei
Country [119] 0 0
China
State/province [119] 0 0
Hunan
Country [120] 0 0
China
State/province [120] 0 0
Inner Mongolia
Country [121] 0 0
China
State/province [121] 0 0
Jiangsu
Country [122] 0 0
China
State/province [122] 0 0
Jiangxi
Country [123] 0 0
China
State/province [123] 0 0
Jilin
Country [124] 0 0
China
State/province [124] 0 0
Liaoning
Country [125] 0 0
China
State/province [125] 0 0
Shandong
Country [126] 0 0
China
State/province [126] 0 0
Shanghai
Country [127] 0 0
China
State/province [127] 0 0
Shanxi
Country [128] 0 0
China
State/province [128] 0 0
Sichuan
Country [129] 0 0
China
State/province [129] 0 0
Tianjin
Country [130] 0 0
China
State/province [130] 0 0
Xinjiang
Country [131] 0 0
China
State/province [131] 0 0
Zhejiang
Country [132] 0 0
China
State/province [132] 0 0
Beijing
Country [133] 0 0
China
State/province [133] 0 0
Guang Zhou
Country [134] 0 0
China
State/province [134] 0 0
Guangzhou
Country [135] 0 0
China
State/province [135] 0 0
Jinan
Country [136] 0 0
China
State/province [136] 0 0
Xiamen
Country [137] 0 0
Colombia
State/province [137] 0 0
Antioquia
Country [138] 0 0
Colombia
State/province [138] 0 0
Atlantico
Country [139] 0 0
Colombia
State/province [139] 0 0
Bolivar
Country [140] 0 0
Colombia
State/province [140] 0 0
Caldas
Country [141] 0 0
Colombia
State/province [141] 0 0
Risaralda
Country [142] 0 0
Colombia
State/province [142] 0 0
Valle Del Cauca
Country [143] 0 0
Colombia
State/province [143] 0 0
Barranquilla
Country [144] 0 0
Colombia
State/province [144] 0 0
Bogota
Country [145] 0 0
Colombia
State/province [145] 0 0
Cali
Country [146] 0 0
Colombia
State/province [146] 0 0
Florida Blanca
Country [147] 0 0
Croatia
State/province [147] 0 0
Cakovec
Country [148] 0 0
Croatia
State/province [148] 0 0
Krapinske toplice
Country [149] 0 0
Croatia
State/province [149] 0 0
Opatija
Country [150] 0 0
Croatia
State/province [150] 0 0
Osijek
Country [151] 0 0
Croatia
State/province [151] 0 0
Rijeka
Country [152] 0 0
Croatia
State/province [152] 0 0
Slavonski Brod
Country [153] 0 0
Croatia
State/province [153] 0 0
Split
Country [154] 0 0
Croatia
State/province [154] 0 0
Zagreb
Country [155] 0 0
Czechia
State/province [155] 0 0
Czech Republic
Country [156] 0 0
Czechia
State/province [156] 0 0
CZE
Country [157] 0 0
Czechia
State/province [157] 0 0
Bedihost
Country [158] 0 0
Czechia
State/province [158] 0 0
Brno Bohunice
Country [159] 0 0
Czechia
State/province [159] 0 0
Brno
Country [160] 0 0
Czechia
State/province [160] 0 0
Hodonin
Country [161] 0 0
Czechia
State/province [161] 0 0
Hradec Kralove
Country [162] 0 0
Czechia
State/province [162] 0 0
JIhlava
Country [163] 0 0
Czechia
State/province [163] 0 0
Marianske lazne
Country [164] 0 0
Czechia
State/province [164] 0 0
Nachod
Country [165] 0 0
Czechia
State/province [165] 0 0
Ostrava
Country [166] 0 0
Czechia
State/province [166] 0 0
Pardubice
Country [167] 0 0
Czechia
State/province [167] 0 0
Praha 10
Country [168] 0 0
Czechia
State/province [168] 0 0
Praha 5
Country [169] 0 0
Czechia
State/province [169] 0 0
Praha
Country [170] 0 0
Czechia
State/province [170] 0 0
Prerov
Country [171] 0 0
Czechia
State/province [171] 0 0
Pribram VIII
Country [172] 0 0
Czechia
State/province [172] 0 0
Uherske Hradiste
Country [173] 0 0
Czechia
State/province [173] 0 0
Zlin
Country [174] 0 0
Denmark
State/province [174] 0 0
Central Jutland
Country [175] 0 0
Denmark
State/province [175] 0 0
Arhus C
Country [176] 0 0
Denmark
State/province [176] 0 0
Esbjerg
Country [177] 0 0
Denmark
State/province [177] 0 0
Glostrup
Country [178] 0 0
Denmark
State/province [178] 0 0
Herlev
Country [179] 0 0
Denmark
State/province [179] 0 0
Hjorring
Country [180] 0 0
Denmark
State/province [180] 0 0
Roskilde
Country [181] 0 0
Denmark
State/province [181] 0 0
Svendborg
Country [182] 0 0
Denmark
State/province [182] 0 0
Viborg
Country [183] 0 0
Estonia
State/province [183] 0 0
Parnu
Country [184] 0 0
Estonia
State/province [184] 0 0
Tallinn
Country [185] 0 0
Estonia
State/province [185] 0 0
Tartu
Country [186] 0 0
Finland
State/province [186] 0 0
Pohjois Savo
Country [187] 0 0
Finland
State/province [187] 0 0
Helsinki
Country [188] 0 0
Finland
State/province [188] 0 0
Jyvaskyla
Country [189] 0 0
Finland
State/province [189] 0 0
Turku
Country [190] 0 0
France
State/province [190] 0 0
Cedex1
Country [191] 0 0
France
State/province [191] 0 0
Amiens
Country [192] 0 0
France
State/province [192] 0 0
Beziers Cedex
Country [193] 0 0
France
State/province [193] 0 0
Brest
Country [194] 0 0
France
State/province [194] 0 0
Chambray les Tours
Country [195] 0 0
France
State/province [195] 0 0
Cholet
Country [196] 0 0
France
State/province [196] 0 0
Clermont Ferrand
Country [197] 0 0
France
State/province [197] 0 0
Corbeil Essonnes
Country [198] 0 0
France
State/province [198] 0 0
Grenoble Cedex 9
Country [199] 0 0
France
State/province [199] 0 0
Le Coudray
Country [200] 0 0
France
State/province [200] 0 0
Lille
Country [201] 0 0
France
State/province [201] 0 0
Limoges
Country [202] 0 0
France
State/province [202] 0 0
Marseille
Country [203] 0 0
France
State/province [203] 0 0
Metz
Country [204] 0 0
France
State/province [204] 0 0
Montauban
Country [205] 0 0
France
State/province [205] 0 0
Montpellier
Country [206] 0 0
France
State/province [206] 0 0
Nimes
Country [207] 0 0
France
State/province [207] 0 0
Orleans
Country [208] 0 0
France
State/province [208] 0 0
Paris 13
Country [209] 0 0
France
State/province [209] 0 0
Paris cedex 10
Country [210] 0 0
France
State/province [210] 0 0
Paris
Country [211] 0 0
France
State/province [211] 0 0
Pau Cedex
Country [212] 0 0
France
State/province [212] 0 0
Pessac Cedex
Country [213] 0 0
France
State/province [213] 0 0
Poitiers
Country [214] 0 0
France
State/province [214] 0 0
Reims
Country [215] 0 0
France
State/province [215] 0 0
Rennes
Country [216] 0 0
France
State/province [216] 0 0
Toulouse 4
Country [217] 0 0
France
State/province [217] 0 0
Tourcoing
Country [218] 0 0
France
State/province [218] 0 0
Valenciennes
Country [219] 0 0
Greece
State/province [219] 0 0
GR
Country [220] 0 0
Greece
State/province [220] 0 0
Athens
Country [221] 0 0
Greece
State/province [221] 0 0
Thessaloniki
Country [222] 0 0
Hungary
State/province [222] 0 0
Csongrad
Country [223] 0 0
Hungary
State/province [223] 0 0
Baja
Country [224] 0 0
Hungary
State/province [224] 0 0
Balassagyarmat
Country [225] 0 0
Hungary
State/province [225] 0 0
Balatonfured
Country [226] 0 0
Hungary
State/province [226] 0 0
Budapest
Country [227] 0 0
Hungary
State/province [227] 0 0
Debrecen
Country [228] 0 0
Hungary
State/province [228] 0 0
Kalocsa
Country [229] 0 0
Hungary
State/province [229] 0 0
Kecskemet
Country [230] 0 0
Hungary
State/province [230] 0 0
Kistarcsa
Country [231] 0 0
Hungary
State/province [231] 0 0
Komarom
Country [232] 0 0
Hungary
State/province [232] 0 0
Nagykanizsa
Country [233] 0 0
Hungary
State/province [233] 0 0
Oroshaza
Country [234] 0 0
Hungary
State/province [234] 0 0
Pecs
Country [235] 0 0
Hungary
State/province [235] 0 0
Pécs
Country [236] 0 0
Hungary
State/province [236] 0 0
Szeged
Country [237] 0 0
Hungary
State/province [237] 0 0
Szekszard
Country [238] 0 0
Hungary
State/province [238] 0 0
Szolnok
Country [239] 0 0
Hungary
State/province [239] 0 0
Zalaegerszeg
Country [240] 0 0
Iceland
State/province [240] 0 0
Kopavogur
Country [241] 0 0
Iceland
State/province [241] 0 0
Reykjavik
Country [242] 0 0
India
State/province [242] 0 0
Andhra Pradesh
Country [243] 0 0
India
State/province [243] 0 0
Andhrapradesh
Country [244] 0 0
India
State/province [244] 0 0
Delhi
Country [245] 0 0
India
State/province [245] 0 0
Gujarat
Country [246] 0 0
India
State/province [246] 0 0
Karnataka
Country [247] 0 0
India
State/province [247] 0 0
Kerala
Country [248] 0 0
India
State/province [248] 0 0
Madhyapradesh
Country [249] 0 0
India
State/province [249] 0 0
Maharashtra
Country [250] 0 0
India
State/province [250] 0 0
Rajasthan
Country [251] 0 0
India
State/province [251] 0 0
Tamil Nadu
Country [252] 0 0
India
State/province [252] 0 0
Telangana
Country [253] 0 0
India
State/province [253] 0 0
Uttar Pradesh
Country [254] 0 0
India
State/province [254] 0 0
Uttarakhand
Country [255] 0 0
India
State/province [255] 0 0
Uttrakhand
Country [256] 0 0
India
State/province [256] 0 0
West Bengal
Country [257] 0 0
India
State/province [257] 0 0
Belgavi
Country [258] 0 0
India
State/province [258] 0 0
Coimbatore
Country [259] 0 0
India
State/province [259] 0 0
New Delhi
Country [260] 0 0
India
State/province [260] 0 0
Puducherry
Country [261] 0 0
Israel
State/province [261] 0 0
HaMerkaz
Country [262] 0 0
Israel
State/province [262] 0 0
Ashdod
Country [263] 0 0
Israel
State/province [263] 0 0
Jerusalem
Country [264] 0 0
Israel
State/province [264] 0 0
Nahariya
Country [265] 0 0
Israel
State/province [265] 0 0
Petach Tikva
Country [266] 0 0
Israel
State/province [266] 0 0
Ramat Gan
Country [267] 0 0
Israel
State/province [267] 0 0
Safed
Country [268] 0 0
Israel
State/province [268] 0 0
Tel Giborim, Holon
Country [269] 0 0
Italy
State/province [269] 0 0
BO
Country [270] 0 0
Italy
State/province [270] 0 0
BS
Country [271] 0 0
Italy
State/province [271] 0 0
FE
Country [272] 0 0
Italy
State/province [272] 0 0
FI
Country [273] 0 0
Italy
State/province [273] 0 0
GR
Country [274] 0 0
Italy
State/province [274] 0 0
IS
Country [275] 0 0
Italy
State/province [275] 0 0
MI
Country [276] 0 0
Italy
State/province [276] 0 0
MO
Country [277] 0 0
Italy
State/province [277] 0 0
PN
Country [278] 0 0
Italy
State/province [278] 0 0
SI
Country [279] 0 0
Italy
State/province [279] 0 0
TO
Country [280] 0 0
Italy
State/province [280] 0 0
Sassari
Country [281] 0 0
Japan
State/province [281] 0 0
Aichi
Country [282] 0 0
Japan
State/province [282] 0 0
Fukuka
Country [283] 0 0
Japan
State/province [283] 0 0
Ishikawa
Country [284] 0 0
Japan
State/province [284] 0 0
Kanagawa
Country [285] 0 0
Japan
State/province [285] 0 0
Niigata
Country [286] 0 0
Japan
State/province [286] 0 0
Osaka
Country [287] 0 0
Japan
State/province [287] 0 0
Saitama
Country [288] 0 0
Japan
State/province [288] 0 0
Nagasaki
Country [289] 0 0
Kenya
State/province [289] 0 0
Nairobi
Country [290] 0 0
Korea, Republic of
State/province [290] 0 0
Chungcheongbuk Do
Country [291] 0 0
Korea, Republic of
State/province [291] 0 0
Dalseo Gu
Country [292] 0 0
Korea, Republic of
State/province [292] 0 0
Gangwon-Do
Country [293] 0 0
Korea, Republic of
State/province [293] 0 0
Gyeonggi Do
Country [294] 0 0
Korea, Republic of
State/province [294] 0 0
Gyeongsangnam Do
Country [295] 0 0
Korea, Republic of
State/province [295] 0 0
Korea
Country [296] 0 0
Korea, Republic of
State/province [296] 0 0
Seocho Gu
Country [297] 0 0
Korea, Republic of
State/province [297] 0 0
Busan
Country [298] 0 0
Korea, Republic of
State/province [298] 0 0
Daegu
Country [299] 0 0
Korea, Republic of
State/province [299] 0 0
Daejeon
Country [300] 0 0
Korea, Republic of
State/province [300] 0 0
Gwangju
Country [301] 0 0
Korea, Republic of
State/province [301] 0 0
Incheon
Country [302] 0 0
Korea, Republic of
State/province [302] 0 0
Jinju
Country [303] 0 0
Korea, Republic of
State/province [303] 0 0
Seoul
Country [304] 0 0
Latvia
State/province [304] 0 0
LV
Country [305] 0 0
Latvia
State/province [305] 0 0
Daugavpils
Country [306] 0 0
Latvia
State/province [306] 0 0
Kuldiga
Country [307] 0 0
Latvia
State/province [307] 0 0
Riga
Country [308] 0 0
Latvia
State/province [308] 0 0
Valmiera
Country [309] 0 0
Lithuania
State/province [309] 0 0
Kauno Apskritis
Country [310] 0 0
Lithuania
State/province [310] 0 0
Klaipedos Apskritis
Country [311] 0 0
Lithuania
State/province [311] 0 0
LTU
Country [312] 0 0
Lithuania
State/province [312] 0 0
Siauliu Apskritis
Country [313] 0 0
Lithuania
State/province [313] 0 0
Kaunas
Country [314] 0 0
Lithuania
State/province [314] 0 0
Panevezys
Country [315] 0 0
Lithuania
State/province [315] 0 0
Vilnius
Country [316] 0 0
Malaysia
State/province [316] 0 0
Kedah
Country [317] 0 0
Malaysia
State/province [317] 0 0
MYS
Country [318] 0 0
Malaysia
State/province [318] 0 0
Pahang
Country [319] 0 0
Malaysia
State/province [319] 0 0
Perak
Country [320] 0 0
Malaysia
State/province [320] 0 0
Selangor Darul Ehsan
Country [321] 0 0
Malaysia
State/province [321] 0 0
Kuala Lumpur
Country [322] 0 0
Mauritius
State/province [322] 0 0
Phoenix
Country [323] 0 0
Mauritius
State/province [323] 0 0
Solferino Phoenix
Country [324] 0 0
Mexico
State/province [324] 0 0
Distrito Federal
Country [325] 0 0
Mexico
State/province [325] 0 0
Edo De Mexico
Country [326] 0 0
Mexico
State/province [326] 0 0
Jalisco
Country [327] 0 0
Mexico
State/province [327] 0 0
Nuevo Leon
Country [328] 0 0
Mexico
State/province [328] 0 0
Yucatan
Country [329] 0 0
Mexico
State/province [329] 0 0
Acapulco
Country [330] 0 0
Mexico
State/province [330] 0 0
Aguascalientes
Country [331] 0 0
Mexico
State/province [331] 0 0
Chihuahua
Country [332] 0 0
Mexico
State/province [332] 0 0
Durango
Country [333] 0 0
Mexico
State/province [333] 0 0
Guadalajara
Country [334] 0 0
Mexico
State/province [334] 0 0
Xalapa
Country [335] 0 0
Netherlands
State/province [335] 0 0
The Netherlands
Country [336] 0 0
Netherlands
State/province [336] 0 0
Alkmaar
Country [337] 0 0
Netherlands
State/province [337] 0 0
Amersfoort
Country [338] 0 0
Netherlands
State/province [338] 0 0
Amstelveen
Country [339] 0 0
Netherlands
State/province [339] 0 0
Amsterdam
Country [340] 0 0
Netherlands
State/province [340] 0 0
Breda
Country [341] 0 0
Netherlands
State/province [341] 0 0
Deventer
Country [342] 0 0
Netherlands
State/province [342] 0 0
Doetinchem
Country [343] 0 0
Netherlands
State/province [343] 0 0
Gouda
Country [344] 0 0
Netherlands
State/province [344] 0 0
Groningen
Country [345] 0 0
Netherlands
State/province [345] 0 0
Heemstede
Country [346] 0 0
Netherlands
State/province [346] 0 0
Leeuwarden
Country [347] 0 0
Netherlands
State/province [347] 0 0
Leiden
Country [348] 0 0
Netherlands
State/province [348] 0 0
Leiderdorp
Country [349] 0 0
Netherlands
State/province [349] 0 0
Meibergdreef 9
Country [350] 0 0
Netherlands
State/province [350] 0 0
Meppel
Country [351] 0 0
Netherlands
State/province [351] 0 0
Nijmegen
Country [352] 0 0
Netherlands
State/province [352] 0 0
Tiel
Country [353] 0 0
Netherlands
State/province [353] 0 0
Tilburg
Country [354] 0 0
Netherlands
State/province [354] 0 0
Venlo
Country [355] 0 0
New Zealand
State/province [355] 0 0
Auckland
Country [356] 0 0
New Zealand
State/province [356] 0 0
Canterbury
Country [357] 0 0
New Zealand
State/province [357] 0 0
NZW
Country [358] 0 0
New Zealand
State/province [358] 0 0
Christchurch
Country [359] 0 0
New Zealand
State/province [359] 0 0
Hamilton
Country [360] 0 0
New Zealand
State/province [360] 0 0
Lower Hutt
Country [361] 0 0
Norway
State/province [361] 0 0
Oslo
Country [362] 0 0
Norway
State/province [362] 0 0
Arendal
Country [363] 0 0
Norway
State/province [363] 0 0
Drammen
Country [364] 0 0
Norway
State/province [364] 0 0
Skedsmokorset
Country [365] 0 0
Norway
State/province [365] 0 0
Stavanger
Country [366] 0 0
Norway
State/province [366] 0 0
Tromsoe
Country [367] 0 0
Philippines
State/province [367] 0 0
Pampanga
Country [368] 0 0
Philippines
State/province [368] 0 0
Iloilo
Country [369] 0 0
Philippines
State/province [369] 0 0
Quezon
Country [370] 0 0
Philippines
State/province [370] 0 0
San Juan City
Country [371] 0 0
Poland
State/province [371] 0 0
Malopolskie
Country [372] 0 0
Poland
State/province [372] 0 0
Mazowieckie
Country [373] 0 0
Poland
State/province [373] 0 0
Slaskie
Country [374] 0 0
Poland
State/province [374] 0 0
Bialystok
Country [375] 0 0
Poland
State/province [375] 0 0
Bydgoszcz
Country [376] 0 0
Poland
State/province [376] 0 0
Gdynia
Country [377] 0 0
Poland
State/province [377] 0 0
Kielce
Country [378] 0 0
Poland
State/province [378] 0 0
Klodzko
Country [379] 0 0
Poland
State/province [379] 0 0
Krakow
Country [380] 0 0
Poland
State/province [380] 0 0
Lodz
Country [381] 0 0
Poland
State/province [381] 0 0
Lublin
Country [382] 0 0
Poland
State/province [382] 0 0
Olsztyn
Country [383] 0 0
Poland
State/province [383] 0 0
Ostrowiec Swietokrzyski
Country [384] 0 0
Poland
State/province [384] 0 0
Pulawy
Country [385] 0 0
Poland
State/province [385] 0 0
Ruda Slaska
Country [386] 0 0
Poland
State/province [386] 0 0
Skierniewice
Country [387] 0 0
Poland
State/province [387] 0 0
Torun
Country [388] 0 0
Poland
State/province [388] 0 0
Warszawa
Country [389] 0 0
Poland
State/province [389] 0 0
Wloclawek
Country [390] 0 0
Poland
State/province [390] 0 0
Zamosc
Country [391] 0 0
Portugal
State/province [391] 0 0
Lisboa
Country [392] 0 0
Portugal
State/province [392] 0 0
Alcabideche
Country [393] 0 0
Portugal
State/province [393] 0 0
Almada
Country [394] 0 0
Portugal
State/province [394] 0 0
Coimbra
Country [395] 0 0
Portugal
State/province [395] 0 0
Guimaraes
Country [396] 0 0
Portugal
State/province [396] 0 0
Leiria
Country [397] 0 0
Portugal
State/province [397] 0 0
Matosinhos
Country [398] 0 0
Portugal
State/province [398] 0 0
Santa Maria da Feira
Country [399] 0 0
Portugal
State/province [399] 0 0
Vila Nova De Gaia
Country [400] 0 0
Portugal
State/province [400] 0 0
Vila Real
Country [401] 0 0
Puerto Rico
State/province [401] 0 0
Bayamon
Country [402] 0 0
Puerto Rico
State/province [402] 0 0
Ponce
Country [403] 0 0
Puerto Rico
State/province [403] 0 0
San Juan
Country [404] 0 0
Romania
State/province [404] 0 0
Arges
Country [405] 0 0
Romania
State/province [405] 0 0
Jud Bihor
Country [406] 0 0
Romania
State/province [406] 0 0
Mures
Country [407] 0 0
Romania
State/province [407] 0 0
ROM
Country [408] 0 0
Romania
State/province [408] 0 0
Timis
Country [409] 0 0
Romania
State/province [409] 0 0
Baia Mare
Country [410] 0 0
Romania
State/province [410] 0 0
Brasov
Country [411] 0 0
Romania
State/province [411] 0 0
Bucharest
Country [412] 0 0
Romania
State/province [412] 0 0
Bucuresti
Country [413] 0 0
Romania
State/province [413] 0 0
Caracal
Country [414] 0 0
Romania
State/province [414] 0 0
Craiova
Country [415] 0 0
Romania
State/province [415] 0 0
Iasi
Country [416] 0 0
Romania
State/province [416] 0 0
Targu Mures
Country [417] 0 0
Romania
State/province [417] 0 0
Timisoara
Country [418] 0 0
Russian Federation
State/province [418] 0 0
Moscow
Country [419] 0 0
Russian Federation
State/province [419] 0 0
Ryazan
Country [420] 0 0
Russian Federation
State/province [420] 0 0
St Petersburg
Country [421] 0 0
Russian Federation
State/province [421] 0 0
Yaroslavl
Country [422] 0 0
Serbia
State/province [422] 0 0
Belgrade
Country [423] 0 0
Serbia
State/province [423] 0 0
Cuprija
Country [424] 0 0
Serbia
State/province [424] 0 0
Kragujevac
Country [425] 0 0
Serbia
State/province [425] 0 0
Leskovac
Country [426] 0 0
Serbia
State/province [426] 0 0
Nis
Country [427] 0 0
Serbia
State/province [427] 0 0
Smederevo
Country [428] 0 0
Serbia
State/province [428] 0 0
Sremska Kamenica
Country [429] 0 0
Serbia
State/province [429] 0 0
Subotica
Country [430] 0 0
Serbia
State/province [430] 0 0
Vranje
Country [431] 0 0
Serbia
State/province [431] 0 0
Zajecar
Country [432] 0 0
Singapore
State/province [432] 0 0
Singapore
Country [433] 0 0
Slovakia
State/province [433] 0 0
Slovak Republic
Country [434] 0 0
Slovakia
State/province [434] 0 0
SVK
Country [435] 0 0
Slovakia
State/province [435] 0 0
Zilinsky Kraj
Country [436] 0 0
Slovakia
State/province [436] 0 0
Bardejov
Country [437] 0 0
Slovakia
State/province [437] 0 0
Bratislava
Country [438] 0 0
Slovakia
State/province [438] 0 0
Kosice
Country [439] 0 0
Slovakia
State/province [439] 0 0
Lucenec
Country [440] 0 0
Slovakia
State/province [440] 0 0
Moldava nad Bodvou
Country [441] 0 0
Slovakia
State/province [441] 0 0
Nitra
Country [442] 0 0
Slovakia
State/province [442] 0 0
Nove Zamky
Country [443] 0 0
Slovakia
State/province [443] 0 0
Piestany
Country [444] 0 0
Slovakia
State/province [444] 0 0
Povazska Bystrica
Country [445] 0 0
Slovakia
State/province [445] 0 0
Presov
Country [446] 0 0
Slovakia
State/province [446] 0 0
Roznava
Country [447] 0 0
Slovenia
State/province [447] 0 0
Celje
Country [448] 0 0
Slovenia
State/province [448] 0 0
Ljubljana
Country [449] 0 0
Slovenia
State/province [449] 0 0
Ptuj
Country [450] 0 0
Slovenia
State/province [450] 0 0
Slovenj Gradec
Country [451] 0 0
South Africa
State/province [451] 0 0
Centurion
Country [452] 0 0
South Africa
State/province [452] 0 0
Free State
Country [453] 0 0
South Africa
State/province [453] 0 0
Gauteng
Country [454] 0 0
South Africa
State/province [454] 0 0
Western Cape
Country [455] 0 0
South Africa
State/province [455] 0 0
ZAF
Country [456] 0 0
South Africa
State/province [456] 0 0
Bloemfontein
Country [457] 0 0
South Africa
State/province [457] 0 0
Cape Town
Country [458] 0 0
South Africa
State/province [458] 0 0
Midrand
Country [459] 0 0
South Africa
State/province [459] 0 0
Pretoria
Country [460] 0 0
South Africa
State/province [460] 0 0
Worcester
Country [461] 0 0
Spain
State/province [461] 0 0
A Coruna
Country [462] 0 0
Spain
State/province [462] 0 0
Andalucia
Country [463] 0 0
Spain
State/province [463] 0 0
Barcelona
Country [464] 0 0
Spain
State/province [464] 0 0
Cadiz
Country [465] 0 0
Spain
State/province [465] 0 0
Cantabria
Country [466] 0 0
Spain
State/province [466] 0 0
Castilla Y Leon
Country [467] 0 0
Spain
State/province [467] 0 0
Cataluna
Country [468] 0 0
Spain
State/province [468] 0 0
Catalunya
Country [469] 0 0
Spain
State/province [469] 0 0
Comunidad Valenciana
Country [470] 0 0
Spain
State/province [470] 0 0
Galicia
Country [471] 0 0
Spain
State/province [471] 0 0
Islas Baleares
Country [472] 0 0
Spain
State/province [472] 0 0
Madrid
Country [473] 0 0
Spain
State/province [473] 0 0
Murcia
Country [474] 0 0
Spain
State/province [474] 0 0
Pais Vasco
Country [475] 0 0
Spain
State/province [475] 0 0
Pontevedra
Country [476] 0 0
Spain
State/province [476] 0 0
Alicante
Country [477] 0 0
Spain
State/province [477] 0 0
Granada
Country [478] 0 0
Spain
State/province [478] 0 0
Huelva
Country [479] 0 0
Spain
State/province [479] 0 0
Las Palmas de Gran Canaria
Country [480] 0 0
Spain
State/province [480] 0 0
Salamanca
Country [481] 0 0
Spain
State/province [481] 0 0
Zaragoza
Country [482] 0 0
Sweden
State/province [482] 0 0
SE
Country [483] 0 0
Sweden
State/province [483] 0 0
Vastra Gotalands Lan
Country [484] 0 0
Sweden
State/province [484] 0 0
Falun
Country [485] 0 0
Sweden
State/province [485] 0 0
Goteborg
Country [486] 0 0
Sweden
State/province [486] 0 0
Lund
Country [487] 0 0
Sweden
State/province [487] 0 0
Malmo
Country [488] 0 0
Sweden
State/province [488] 0 0
Stockholm
Country [489] 0 0
Sweden
State/province [489] 0 0
Vasteras
Country [490] 0 0
Taiwan
State/province [490] 0 0
Kaohsiung
Country [491] 0 0
Taiwan
State/province [491] 0 0
Tainan
Country [492] 0 0
Taiwan
State/province [492] 0 0
Taipei
Country [493] 0 0
Thailand
State/province [493] 0 0
Songkla
Country [494] 0 0
Thailand
State/province [494] 0 0
Bangkok
Country [495] 0 0
Thailand
State/province [495] 0 0
Chiang Mai
Country [496] 0 0
Thailand
State/province [496] 0 0
Muang
Country [497] 0 0
Turkey
State/province [497] 0 0
TUR
Country [498] 0 0
Turkey
State/province [498] 0 0
Adana
Country [499] 0 0
Turkey
State/province [499] 0 0
Ankara
Country [500] 0 0
Turkey
State/province [500] 0 0
Bursa
Country [501] 0 0
Turkey
State/province [501] 0 0
Cerrahpasa/Istanbul
Country [502] 0 0
Turkey
State/province [502] 0 0
Diskapi Ankara
Country [503] 0 0
Turkey
State/province [503] 0 0
Istanbul
Country [504] 0 0
Turkey
State/province [504] 0 0
Izmir
Country [505] 0 0
Turkey
State/province [505] 0 0
Konya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05030428