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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05739383
Registration number
NCT05739383
Ethics application status
Date submitted
13/02/2023
Date registered
22/02/2023
Date last updated
18/06/2024
Titles & IDs
Public title
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Scientific title
A Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients (VICTORION-1 PREVENT)
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Secondary ID [1]
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CKJX839D12302
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Treatment: Drugs - Placebo in 1.5ml
Experimental: Inclisiran sodium 300mg - Inclisiran sodium 300 mg in 1.5 mL solution for injection (subcutaneous) in pre-filled syringe.
Randomized in a 1:1 ratio with matching placebo
Placebo comparator: Placebo - Matching placebo in 1.5ml pre-filled syringe. Randomized in a 1:1 ratio with Inclisiran.
Treatment: Drugs: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Subcutaneous injection in pre-filled syringe.
Treatment: Drugs: Placebo in 1.5ml
Matching placebo in 1.5ml solution for injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to the first occurrence of 4P-MACE
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Assessment method [1]
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4-Point-Major Adverse Cardiovascular Events (4P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization.
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Timepoint [1]
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Time to the first occurrence of 4P-MACE (up to approximately 75 months)
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Secondary outcome [1]
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Time to the first occurrence of 3P-MACE
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Assessment method [1]
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3-Point-Major Adverse Cardiovascular Events (3P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke)
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Timepoint [1]
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Time to the first occurrence of 3P-MACE (up to approximately 75 months)
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Secondary outcome [2]
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Total number of first or repeated CV events (4P MACE)
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Assessment method [2]
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Total 4P-MACE (composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization)
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Timepoint [2]
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up to 75 months
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Secondary outcome [3]
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Total number of first or repeated CV events (3P MACE)
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Assessment method [3]
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Total 3P-MACE (composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke)
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Timepoint [3]
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up to 75 months
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Secondary outcome [4]
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Time to occurrence of Cardiovascular death
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Assessment method [4]
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CV death is defined as death due to cardiovascular events.
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Timepoint [4]
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Time to Cardiovascular death (up to 75 months)
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Secondary outcome [5]
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Time to occurrence of death due to any reason
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Assessment method [5]
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All-cause mortality is death due to any reason.
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Timepoint [5]
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Time to all-cause mortality (up to 75 months)
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Eligibility
Key inclusion criteria
* At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:
1. Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis =20% but <50% in the left main coronary artery or stenosis =20% but <70% in any other major epicardial coronary artery, or
2. Coronary artery calcium (CAC) score obtained by CT-scan =100 Agatston units, or
3. High 10-year ASCVD risk =20%, or
4. Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors.
* LDL-C =70 mg/dL (=1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit. If on a background lipid lowering therapy, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study.
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Minimum age
40
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Maximum age
79
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of major ASCVD event.
* History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization
* Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization
* Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization
* Active liver disease or hepatic dysfunction
* Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab)
* Pregnant or nursing (lactating) women
* Women of childbearing potential unless they are using effective methods of contraception while taking study treatment which includes for 6 months after last study drug administration
Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
16/04/2029
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Actual
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Sample size
Target
14000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Canberra
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2605 - Canberra
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2050 - Camperdown
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2139 - Concord
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4066 - Auchenflower
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4556 - Sippy Downs
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4102 - Woolloongabba
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5000 - Adelaide
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5068 - Leabrook
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7000 - Hobart
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3168 - Clayton
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3081 - Heidelberg Heights
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3145 - Malvern East
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6150 - Murdoch
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Recruitment outside Australia
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Liaoning
Query!
Country [115]
0
0
China
Query!
State/province [115]
0
0
Ningxia
Query!
Country [116]
0
0
China
Query!
State/province [116]
0
0
Shaanxi
Query!
Country [117]
0
0
China
Query!
State/province [117]
0
0
Shandong
Query!
Country [118]
0
0
China
Query!
State/province [118]
0
0
Shanxi
Query!
Country [119]
0
0
China
Query!
State/province [119]
0
0
Tianjin
Query!
Country [120]
0
0
China
Query!
State/province [120]
0
0
Zhejiang
Query!
Country [121]
0
0
China
Query!
State/province [121]
0
0
Beijing
Query!
Country [122]
0
0
China
Query!
State/province [122]
0
0
Guang Zhou
Query!
Country [123]
0
0
China
Query!
State/province [123]
0
0
Jining
Query!
Country [124]
0
0
China
Query!
State/province [124]
0
0
Shanghai
Query!
Country [125]
0
0
China
Query!
State/province [125]
0
0
Shijiazhuang
Query!
Country [126]
0
0
Colombia
Query!
State/province [126]
0
0
Antioquia
Query!
Country [127]
0
0
Colombia
Query!
State/province [127]
0
0
Atlantico
Query!
Country [128]
0
0
Colombia
Query!
State/province [128]
0
0
Cundinamarca
Query!
Country [129]
0
0
Colombia
Query!
State/province [129]
0
0
Santander
Query!
Country [130]
0
0
Colombia
Query!
State/province [130]
0
0
Tolima
Query!
Country [131]
0
0
Colombia
Query!
State/province [131]
0
0
Valle Del Cauca
Query!
Country [132]
0
0
Colombia
Query!
State/province [132]
0
0
Barranquilla
Query!
Country [133]
0
0
Colombia
Query!
State/province [133]
0
0
Bogota
Query!
Country [134]
0
0
Colombia
Query!
State/province [134]
0
0
Cali
Query!
Country [135]
0
0
Colombia
Query!
State/province [135]
0
0
Manizales
Query!
Country [136]
0
0
Colombia
Query!
State/province [136]
0
0
Medellin
Query!
Country [137]
0
0
Colombia
Query!
State/province [137]
0
0
San Gil
Query!
Country [138]
0
0
Croatia
Query!
State/province [138]
0
0
Karlovacka Zupanija
Query!
Country [139]
0
0
Croatia
Query!
State/province [139]
0
0
Osijek Baranja
Query!
Country [140]
0
0
Croatia
Query!
State/province [140]
0
0
Primorsko Goranska Zupanija
Query!
Country [141]
0
0
Croatia
Query!
State/province [141]
0
0
Krapinske toplice
Query!
Country [142]
0
0
Croatia
Query!
State/province [142]
0
0
Krapinske Toplice
Query!
Country [143]
0
0
Croatia
Query!
State/province [143]
0
0
Opatija
Query!
Country [144]
0
0
Croatia
Query!
State/province [144]
0
0
Osijek
Query!
Country [145]
0
0
Croatia
Query!
State/province [145]
0
0
Pula
Query!
Country [146]
0
0
Croatia
Query!
State/province [146]
0
0
Slavonski Brod
Query!
Country [147]
0
0
Croatia
Query!
State/province [147]
0
0
Zagreb
Query!
Country [148]
0
0
Czechia
Query!
State/province [148]
0
0
Czech Republic
Query!
Country [149]
0
0
Czechia
Query!
State/province [149]
0
0
CZE
Query!
Country [150]
0
0
Czechia
Query!
State/province [150]
0
0
Olomoucky Kraj
Query!
Country [151]
0
0
Czechia
Query!
State/province [151]
0
0
Cesky Krumlov
Query!
Country [152]
0
0
Czechia
Query!
State/province [152]
0
0
Chlumec nad Cidlinou
Query!
Country [153]
0
0
Czechia
Query!
State/province [153]
0
0
Hlucin
Query!
Country [154]
0
0
Czechia
Query!
State/province [154]
0
0
Hodonin
Query!
Country [155]
0
0
Czechia
Query!
State/province [155]
0
0
JIhlava
Query!
Country [156]
0
0
Czechia
Query!
State/province [156]
0
0
Kolin
Query!
Country [157]
0
0
Czechia
Query!
State/province [157]
0
0
Liberec
Query!
Country [158]
0
0
Czechia
Query!
State/province [158]
0
0
Marianske lazne
Query!
Country [159]
0
0
Czechia
Query!
State/province [159]
0
0
Nachod
Query!
Country [160]
0
0
Czechia
Query!
State/province [160]
0
0
Olomouc
Query!
Country [161]
0
0
Czechia
Query!
State/province [161]
0
0
Ostrava
Query!
Country [162]
0
0
Czechia
Query!
State/province [162]
0
0
Plzen
Query!
Country [163]
0
0
Czechia
Query!
State/province [163]
0
0
Prague 5
Query!
Country [164]
0
0
Czechia
Query!
State/province [164]
0
0
Praha 11
Query!
Country [165]
0
0
Czechia
Query!
State/province [165]
0
0
Praha
Query!
Country [166]
0
0
Czechia
Query!
State/province [166]
0
0
Uherske Hradiste
Query!
Country [167]
0
0
Czechia
Query!
State/province [167]
0
0
Usti nad Labem
Query!
Country [168]
0
0
Czechia
Query!
State/province [168]
0
0
Zlin
Query!
Country [169]
0
0
Denmark
Query!
State/province [169]
0
0
Aarhus N
Query!
Country [170]
0
0
Denmark
Query!
State/province [170]
0
0
Copenhagen NV
Query!
Country [171]
0
0
Denmark
Query!
State/province [171]
0
0
Copenhagen S
Query!
Country [172]
0
0
Denmark
Query!
State/province [172]
0
0
Esbjerg
Query!
Country [173]
0
0
Denmark
Query!
State/province [173]
0
0
Gandrup
Query!
Country [174]
0
0
Denmark
Query!
State/province [174]
0
0
Herlev
Query!
Country [175]
0
0
Denmark
Query!
State/province [175]
0
0
Herning
Query!
Country [176]
0
0
Denmark
Query!
State/province [176]
0
0
Roskilde
Query!
Country [177]
0
0
Denmark
Query!
State/province [177]
0
0
Svendborg
Query!
Country [178]
0
0
Denmark
Query!
State/province [178]
0
0
Vejle
Query!
Country [179]
0
0
Estonia
Query!
State/province [179]
0
0
Parnu
Query!
Country [180]
0
0
Estonia
Query!
State/province [180]
0
0
Tallinn
Query!
Country [181]
0
0
Estonia
Query!
State/province [181]
0
0
Tartu
Query!
Country [182]
0
0
France
Query!
State/province [182]
0
0
Isere
Query!
Country [183]
0
0
France
Query!
State/province [183]
0
0
Seine Saint Denis
Query!
Country [184]
0
0
France
Query!
State/province [184]
0
0
Avignon
Query!
Country [185]
0
0
France
Query!
State/province [185]
0
0
Besancon Cedex
Query!
Country [186]
0
0
France
Query!
State/province [186]
0
0
Beziers Cedex
Query!
Country [187]
0
0
France
Query!
State/province [187]
0
0
Bois Guillaume
Query!
Country [188]
0
0
France
Query!
State/province [188]
0
0
Bordeaux Cedex
Query!
Country [189]
0
0
France
Query!
State/province [189]
0
0
Caen Cedex9
Query!
Country [190]
0
0
France
Query!
State/province [190]
0
0
Compiegne
Query!
Country [191]
0
0
France
Query!
State/province [191]
0
0
Dijon
Query!
Country [192]
0
0
France
Query!
State/province [192]
0
0
Lille
Query!
Country [193]
0
0
France
Query!
State/province [193]
0
0
Marseille
Query!
Country [194]
0
0
France
Query!
State/province [194]
0
0
Montauban
Query!
Country [195]
0
0
France
Query!
State/province [195]
0
0
Montpellier Cedex 5
Query!
Country [196]
0
0
France
Query!
State/province [196]
0
0
Nantes Cedex 1
Query!
Country [197]
0
0
France
Query!
State/province [197]
0
0
Nice
Query!
Country [198]
0
0
France
Query!
State/province [198]
0
0
Orleans
Query!
Country [199]
0
0
France
Query!
State/province [199]
0
0
Paris 13
Query!
Country [200]
0
0
France
Query!
State/province [200]
0
0
Paris
Query!
Country [201]
0
0
France
Query!
State/province [201]
0
0
Poitiers
Query!
Country [202]
0
0
France
Query!
State/province [202]
0
0
Rouen
Query!
Country [203]
0
0
France
Query!
State/province [203]
0
0
Strasbourg Cedex
Query!
Country [204]
0
0
France
Query!
State/province [204]
0
0
Tourcoing
Query!
Country [205]
0
0
France
Query!
State/province [205]
0
0
Valenciennes
Query!
Country [206]
0
0
France
Query!
State/province [206]
0
0
Vandoeuvre Les Nnacy
Query!
Country [207]
0
0
Greece
Query!
State/province [207]
0
0
GR
Query!
Country [208]
0
0
Greece
Query!
State/province [208]
0
0
Athens
Query!
Country [209]
0
0
Greece
Query!
State/province [209]
0
0
Heraklion Crete
Query!
Country [210]
0
0
Greece
Query!
State/province [210]
0
0
Thessaloniki
Query!
Country [211]
0
0
Hong Kong
Query!
State/province [211]
0
0
Hong Kong SAR
Query!
Country [212]
0
0
Hong Kong
Query!
State/province [212]
0
0
Hongkong
Query!
Country [213]
0
0
Hong Kong
Query!
State/province [213]
0
0
Kowloon
Query!
Country [214]
0
0
Hong Kong
Query!
State/province [214]
0
0
Pokfulam
Query!
Country [215]
0
0
Hungary
Query!
State/province [215]
0
0
Pest
Query!
Country [216]
0
0
Hungary
Query!
State/province [216]
0
0
Zala
Query!
Country [217]
0
0
Hungary
Query!
State/province [217]
0
0
Balatonfured
Query!
Country [218]
0
0
Hungary
Query!
State/province [218]
0
0
Budapest
Query!
Country [219]
0
0
Hungary
Query!
State/province [219]
0
0
Debrecen
Query!
Country [220]
0
0
Hungary
Query!
State/province [220]
0
0
Hatvan
Query!
Country [221]
0
0
Hungary
Query!
State/province [221]
0
0
Hosszuheteny
Query!
Country [222]
0
0
Hungary
Query!
State/province [222]
0
0
Mosanmagyarovar
Query!
Country [223]
0
0
Hungary
Query!
State/province [223]
0
0
Nyiregyhaza
Query!
Country [224]
0
0
Hungary
Query!
State/province [224]
0
0
Pecs
Query!
Country [225]
0
0
Hungary
Query!
State/province [225]
0
0
Szeged
Query!
Country [226]
0
0
Hungary
Query!
State/province [226]
0
0
Szekszard
Query!
Country [227]
0
0
Hungary
Query!
State/province [227]
0
0
Zalaegerszeg
Query!
Country [228]
0
0
India
Query!
State/province [228]
0
0
Andhrapradesh
Query!
Country [229]
0
0
India
Query!
State/province [229]
0
0
Delhi
Query!
Country [230]
0
0
India
Query!
State/province [230]
0
0
Gujarat
Query!
Country [231]
0
0
India
Query!
State/province [231]
0
0
Karnataka
Query!
Country [232]
0
0
India
Query!
State/province [232]
0
0
Kerala
Query!
Country [233]
0
0
India
Query!
State/province [233]
0
0
Maharashtra
Query!
Country [234]
0
0
India
Query!
State/province [234]
0
0
Rajasthan
Query!
Country [235]
0
0
India
Query!
State/province [235]
0
0
Tamil Nadu
Query!
Country [236]
0
0
India
Query!
State/province [236]
0
0
Telangana
Query!
Country [237]
0
0
India
Query!
State/province [237]
0
0
Uttar Pradesh
Query!
Country [238]
0
0
India
Query!
State/province [238]
0
0
Uttarakhand
Query!
Country [239]
0
0
India
Query!
State/province [239]
0
0
Uttrakhand
Query!
Country [240]
0
0
India
Query!
State/province [240]
0
0
West Bengal
Query!
Country [241]
0
0
India
Query!
State/province [241]
0
0
Belgavi
Query!
Country [242]
0
0
India
Query!
State/province [242]
0
0
Coimbatore
Query!
Country [243]
0
0
India
Query!
State/province [243]
0
0
New Delhi
Query!
Country [244]
0
0
Israel
Query!
State/province [244]
0
0
Gush Dan
Query!
Country [245]
0
0
Israel
Query!
State/province [245]
0
0
Beer-Sheva
Query!
Country [246]
0
0
Israel
Query!
State/province [246]
0
0
Haifa
Query!
Country [247]
0
0
Israel
Query!
State/province [247]
0
0
Jerusalem
Query!
Country [248]
0
0
Israel
Query!
State/province [248]
0
0
Nahariya
Query!
Country [249]
0
0
Israel
Query!
State/province [249]
0
0
Petach Tikva
Query!
Country [250]
0
0
Israel
Query!
State/province [250]
0
0
Ramat Gan
Query!
Country [251]
0
0
Israel
Query!
State/province [251]
0
0
Rehovot
Query!
Country [252]
0
0
Israel
Query!
State/province [252]
0
0
Sefad
Query!
Country [253]
0
0
Israel
Query!
State/province [253]
0
0
Tel Aviv
Query!
Country [254]
0
0
Israel
Query!
State/province [254]
0
0
Tiberias
Query!
Country [255]
0
0
Italy
Query!
State/province [255]
0
0
AN
Query!
Country [256]
0
0
Italy
Query!
State/province [256]
0
0
BA
Query!
Country [257]
0
0
Italy
Query!
State/province [257]
0
0
BS
Query!
Country [258]
0
0
Italy
Query!
State/province [258]
0
0
CE
Query!
Country [259]
0
0
Italy
Query!
State/province [259]
0
0
CH
Query!
Country [260]
0
0
Italy
Query!
State/province [260]
0
0
FI
Query!
Country [261]
0
0
Italy
Query!
State/province [261]
0
0
GE
Query!
Country [262]
0
0
Italy
Query!
State/province [262]
0
0
IS
Query!
Country [263]
0
0
Italy
Query!
State/province [263]
0
0
MB
Query!
Country [264]
0
0
Italy
Query!
State/province [264]
0
0
ME
Query!
Country [265]
0
0
Italy
Query!
State/province [265]
0
0
MI
Query!
Country [266]
0
0
Italy
Query!
State/province [266]
0
0
MO
Query!
Country [267]
0
0
Italy
Query!
State/province [267]
0
0
PG
Query!
Country [268]
0
0
Italy
Query!
State/province [268]
0
0
PI
Query!
Country [269]
0
0
Italy
Query!
State/province [269]
0
0
RM
Query!
Country [270]
0
0
Italy
Query!
State/province [270]
0
0
SI
Query!
Country [271]
0
0
Italy
Query!
State/province [271]
0
0
Catania
Query!
Country [272]
0
0
Italy
Query!
State/province [272]
0
0
Catanzaro
Query!
Country [273]
0
0
Italy
Query!
State/province [273]
0
0
Latina
Query!
Country [274]
0
0
Italy
Query!
State/province [274]
0
0
Napoli
Query!
Country [275]
0
0
Italy
Query!
State/province [275]
0
0
Roma
Query!
Country [276]
0
0
Latvia
Query!
State/province [276]
0
0
LV
Query!
Country [277]
0
0
Latvia
Query!
State/province [277]
0
0
Daugavpils
Query!
Country [278]
0
0
Latvia
Query!
State/province [278]
0
0
Kuldiga
Query!
Country [279]
0
0
Latvia
Query!
State/province [279]
0
0
Riga
Query!
Country [280]
0
0
Lithuania
Query!
State/province [280]
0
0
Kauno Apskritis
Query!
Country [281]
0
0
Lithuania
Query!
State/province [281]
0
0
Klaipedos Apskritis
Query!
Country [282]
0
0
Lithuania
Query!
State/province [282]
0
0
Alytus
Query!
Country [283]
0
0
Lithuania
Query!
State/province [283]
0
0
Kaunas
Query!
Country [284]
0
0
Lithuania
Query!
State/province [284]
0
0
Panevezys
Query!
Country [285]
0
0
Lithuania
Query!
State/province [285]
0
0
Siauliai
Query!
Country [286]
0
0
Lithuania
Query!
State/province [286]
0
0
Vilnius
Query!
Country [287]
0
0
Malaysia
Query!
State/province [287]
0
0
Kedah
Query!
Country [288]
0
0
Malaysia
Query!
State/province [288]
0
0
Kelantan
Query!
Country [289]
0
0
Malaysia
Query!
State/province [289]
0
0
Negeri Sembilan
Query!
Country [290]
0
0
Malaysia
Query!
State/province [290]
0
0
Perak
Query!
Country [291]
0
0
Malaysia
Query!
State/province [291]
0
0
Pulau Pinang
Query!
Country [292]
0
0
Malaysia
Query!
State/province [292]
0
0
Sarawak
Query!
Country [293]
0
0
Malaysia
Query!
State/province [293]
0
0
Selangor Darul Ehsan
Query!
Country [294]
0
0
Malaysia
Query!
State/province [294]
0
0
Wilayah Persekutuan
Query!
Country [295]
0
0
Malaysia
Query!
State/province [295]
0
0
Johor Bahru
Query!
Country [296]
0
0
Malaysia
Query!
State/province [296]
0
0
Kuala Lumpur
Query!
Country [297]
0
0
Mexico
Query!
State/province [297]
0
0
Cdmx
Query!
Country [298]
0
0
Mexico
Query!
State/province [298]
0
0
Ciudad De Mexico
Query!
Country [299]
0
0
Mexico
Query!
State/province [299]
0
0
Distrito Federal
Query!
Country [300]
0
0
Mexico
Query!
State/province [300]
0
0
Guanajuato
Query!
Country [301]
0
0
Mexico
Query!
State/province [301]
0
0
Hidalgo
Query!
Country [302]
0
0
Mexico
Query!
State/province [302]
0
0
Jalisco
Query!
Country [303]
0
0
Mexico
Query!
State/province [303]
0
0
Morelos
Query!
Country [304]
0
0
Mexico
Query!
State/province [304]
0
0
Nuevo Leon
Query!
Country [305]
0
0
Mexico
Query!
State/province [305]
0
0
Sinaloa
Query!
Country [306]
0
0
Mexico
Query!
State/province [306]
0
0
Tamaulipas
Query!
Country [307]
0
0
Mexico
Query!
State/province [307]
0
0
Yucatan
Query!
Country [308]
0
0
Mexico
Query!
State/province [308]
0
0
Aguascalientes
Query!
Country [309]
0
0
Mexico
Query!
State/province [309]
0
0
Chihuahua
Query!
Country [310]
0
0
Mexico
Query!
State/province [310]
0
0
Mexico D F
Query!
Country [311]
0
0
Mexico
Query!
State/province [311]
0
0
Oaxaca
Query!
Country [312]
0
0
Mexico
Query!
State/province [312]
0
0
San Luis Potosi
Query!
Country [313]
0
0
Mexico
Query!
State/province [313]
0
0
Veracruz
Query!
Country [314]
0
0
Netherlands
Query!
State/province [314]
0
0
The Netherlands
Query!
Country [315]
0
0
Netherlands
Query!
State/province [315]
0
0
Amsterdam
Query!
Country [316]
0
0
Netherlands
Query!
State/province [316]
0
0
Arnhem
Query!
Country [317]
0
0
Netherlands
Query!
State/province [317]
0
0
Beverwijk
Query!
Country [318]
0
0
Netherlands
Query!
State/province [318]
0
0
Delft
Query!
Country [319]
0
0
Netherlands
Query!
State/province [319]
0
0
Den Haag
Query!
Country [320]
0
0
Netherlands
Query!
State/province [320]
0
0
Deventer
Query!
Country [321]
0
0
Netherlands
Query!
State/province [321]
0
0
Dirksland
Query!
Country [322]
0
0
Netherlands
Query!
State/province [322]
0
0
Doetinchem
Query!
Country [323]
0
0
Netherlands
Query!
State/province [323]
0
0
Dordrecht
Query!
Country [324]
0
0
Netherlands
Query!
State/province [324]
0
0
Ede
Query!
Country [325]
0
0
Netherlands
Query!
State/province [325]
0
0
Eindhoven
Query!
Country [326]
0
0
Netherlands
Query!
State/province [326]
0
0
Enschede
Query!
Country [327]
0
0
Netherlands
Query!
State/province [327]
0
0
Gouda
Query!
Country [328]
0
0
Netherlands
Query!
State/province [328]
0
0
Hardenberg
Query!
Country [329]
0
0
Netherlands
Query!
State/province [329]
0
0
Hertogenbosch
Query!
Country [330]
0
0
Netherlands
Query!
State/province [330]
0
0
Leeuwarden
Query!
Country [331]
0
0
Netherlands
Query!
State/province [331]
0
0
Nijmegen
Query!
Country [332]
0
0
Netherlands
Query!
State/province [332]
0
0
Tilburg
Query!
Country [333]
0
0
Netherlands
Query!
State/province [333]
0
0
Venlo
Query!
Country [334]
0
0
Philippines
Query!
State/province [334]
0
0
Iloilo
Query!
Country [335]
0
0
Philippines
Query!
State/province [335]
0
0
Manila
Query!
Country [336]
0
0
Philippines
Query!
State/province [336]
0
0
Quezon
Query!
Country [337]
0
0
Philippines
Query!
State/province [337]
0
0
San Juan City
Query!
Country [338]
0
0
Poland
Query!
State/province [338]
0
0
Malopolskie
Query!
Country [339]
0
0
Poland
Query!
State/province [339]
0
0
Maloposkie
Query!
Country [340]
0
0
Poland
Query!
State/province [340]
0
0
Bialystok
Query!
Country [341]
0
0
Poland
Query!
State/province [341]
0
0
Bydgoszcz
Query!
Country [342]
0
0
Poland
Query!
State/province [342]
0
0
Bygdoszcz
Query!
Country [343]
0
0
Poland
Query!
State/province [343]
0
0
Chorzow
Query!
Country [344]
0
0
Poland
Query!
State/province [344]
0
0
Elblag
Query!
Country [345]
0
0
Poland
Query!
State/province [345]
0
0
Gdansk
Query!
Country [346]
0
0
Poland
Query!
State/province [346]
0
0
Gdynia
Query!
Country [347]
0
0
Poland
Query!
State/province [347]
0
0
Golub-Dobrzyn
Query!
Country [348]
0
0
Poland
Query!
State/province [348]
0
0
Grudziadz
Query!
Country [349]
0
0
Poland
Query!
State/province [349]
0
0
Katowice
Query!
Country [350]
0
0
Poland
Query!
State/province [350]
0
0
Krakow
Query!
Country [351]
0
0
Poland
Query!
State/province [351]
0
0
Krosno
Query!
Country [352]
0
0
Poland
Query!
State/province [352]
0
0
Lodz
Query!
Country [353]
0
0
Poland
Query!
State/province [353]
0
0
Myszkow
Query!
Country [354]
0
0
Poland
Query!
State/province [354]
0
0
Olsztyn
Query!
Country [355]
0
0
Poland
Query!
State/province [355]
0
0
Piotrkow Trybunalski
Query!
Country [356]
0
0
Poland
Query!
State/province [356]
0
0
Rzeszow
Query!
Country [357]
0
0
Poland
Query!
State/province [357]
0
0
Warszawa
Query!
Country [358]
0
0
Poland
Query!
State/province [358]
0
0
Wroclaw
Query!
Country [359]
0
0
Portugal
Query!
State/province [359]
0
0
Lisboa
Query!
Country [360]
0
0
Portugal
Query!
State/province [360]
0
0
Almada
Query!
Country [361]
0
0
Portugal
Query!
State/province [361]
0
0
Coimbra
Query!
Country [362]
0
0
Portugal
Query!
State/province [362]
0
0
Matosinhos
Query!
Country [363]
0
0
Portugal
Query!
State/province [363]
0
0
Porto
Query!
Country [364]
0
0
Portugal
Query!
State/province [364]
0
0
Santa Maria da Feira
Query!
Country [365]
0
0
Portugal
Query!
State/province [365]
0
0
Setubal
Query!
Country [366]
0
0
Portugal
Query!
State/province [366]
0
0
Vila Nova De Gaia
Query!
Country [367]
0
0
Puerto Rico
Query!
State/province [367]
0
0
Ponce
Query!
Country [368]
0
0
Romania
Query!
State/province [368]
0
0
Arges
Query!
Country [369]
0
0
Romania
Query!
State/province [369]
0
0
Bihor
Query!
Country [370]
0
0
Romania
Query!
State/province [370]
0
0
Ilfov
Query!
Country [371]
0
0
Romania
Query!
State/province [371]
0
0
Jud Dolj
Query!
Country [372]
0
0
Romania
Query!
State/province [372]
0
0
Mures
Query!
Country [373]
0
0
Romania
Query!
State/province [373]
0
0
Timis
Query!
Country [374]
0
0
Romania
Query!
State/province [374]
0
0
Baia Mare
Query!
Country [375]
0
0
Romania
Query!
State/province [375]
0
0
Braila
Query!
Country [376]
0
0
Romania
Query!
State/province [376]
0
0
Brasov
Query!
Country [377]
0
0
Romania
Query!
State/province [377]
0
0
Bucharest
Query!
Country [378]
0
0
Romania
Query!
State/province [378]
0
0
Bucuresti
Query!
Country [379]
0
0
Romania
Query!
State/province [379]
0
0
Buzau
Query!
Country [380]
0
0
Romania
Query!
State/province [380]
0
0
Cluj Napoca
Query!
Country [381]
0
0
Romania
Query!
State/province [381]
0
0
Cluj-Napoca
Query!
Country [382]
0
0
Romania
Query!
State/province [382]
0
0
Cluj
Query!
Country [383]
0
0
Romania
Query!
State/province [383]
0
0
Craiova
Query!
Country [384]
0
0
Romania
Query!
State/province [384]
0
0
Lasi
Query!
Country [385]
0
0
Romania
Query!
State/province [385]
0
0
Suceava
Query!
Country [386]
0
0
Romania
Query!
State/province [386]
0
0
Targu Mures
Query!
Country [387]
0
0
Romania
Query!
State/province [387]
0
0
Timisoara
Query!
Country [388]
0
0
Romania
Query!
State/province [388]
0
0
Tirgoviste
Query!
Country [389]
0
0
Singapore
Query!
State/province [389]
0
0
Singapore
Query!
Country [390]
0
0
Slovakia
Query!
State/province [390]
0
0
Slovak Republic
Query!
Country [391]
0
0
Slovakia
Query!
State/province [391]
0
0
Trenciansky Kraj
Query!
Country [392]
0
0
Slovakia
Query!
State/province [392]
0
0
Bardejov
Query!
Country [393]
0
0
Slovakia
Query!
State/province [393]
0
0
Bratislava
Query!
Country [394]
0
0
Slovakia
Query!
State/province [394]
0
0
Dolny Kubin
Query!
Country [395]
0
0
Slovakia
Query!
State/province [395]
0
0
Kosice
Query!
Country [396]
0
0
Slovakia
Query!
State/province [396]
0
0
Kralovsky Chlmec
Query!
Country [397]
0
0
Slovakia
Query!
State/province [397]
0
0
Lubochna
Query!
Country [398]
0
0
Slovakia
Query!
State/province [398]
0
0
Lucenec
Query!
Country [399]
0
0
Slovakia
Query!
State/province [399]
0
0
Malacky
Query!
Country [400]
0
0
Slovakia
Query!
State/province [400]
0
0
Martin
Query!
Country [401]
0
0
Slovakia
Query!
State/province [401]
0
0
Nitra
Query!
Country [402]
0
0
Slovakia
Query!
State/province [402]
0
0
Nove Zamky
Query!
Country [403]
0
0
Slovakia
Query!
State/province [403]
0
0
Presov
Query!
Country [404]
0
0
Slovakia
Query!
State/province [404]
0
0
Samorin
Query!
Country [405]
0
0
Slovakia
Query!
State/province [405]
0
0
Svidnik
Query!
Country [406]
0
0
Slovakia
Query!
State/province [406]
0
0
Trnava
Query!
Country [407]
0
0
South Africa
Query!
State/province [407]
0
0
Eastern Cape
Query!
Country [408]
0
0
South Africa
Query!
State/province [408]
0
0
Free State
Query!
Country [409]
0
0
South Africa
Query!
State/province [409]
0
0
Gauteng
Query!
Country [410]
0
0
South Africa
Query!
State/province [410]
0
0
Kwazulu Natal
Query!
Country [411]
0
0
South Africa
Query!
State/province [411]
0
0
Western Cape
Query!
Country [412]
0
0
South Africa
Query!
State/province [412]
0
0
ZAF
Query!
Country [413]
0
0
South Africa
Query!
State/province [413]
0
0
Cape Town
Query!
Country [414]
0
0
Spain
Query!
State/province [414]
0
0
A Coruna
Query!
Country [415]
0
0
Spain
Query!
State/province [415]
0
0
Alicante
Query!
Country [416]
0
0
Spain
Query!
State/province [416]
0
0
Andalucia
Query!
Country [417]
0
0
Spain
Query!
State/province [417]
0
0
Balears
Query!
Country [418]
0
0
Spain
Query!
State/province [418]
0
0
Barcelona
Query!
Country [419]
0
0
Spain
Query!
State/province [419]
0
0
Cadiz
Query!
Country [420]
0
0
Spain
Query!
State/province [420]
0
0
Cantabria
Query!
Country [421]
0
0
Spain
Query!
State/province [421]
0
0
Castilla Y Leon
Query!
Country [422]
0
0
Spain
Query!
State/province [422]
0
0
Cataluna
Query!
Country [423]
0
0
Spain
Query!
State/province [423]
0
0
Catalunya
Query!
Country [424]
0
0
Spain
Query!
State/province [424]
0
0
Comunidad Valenciana
Query!
Country [425]
0
0
Spain
Query!
State/province [425]
0
0
Extremadura
Query!
Country [426]
0
0
Spain
Query!
State/province [426]
0
0
Galicia
Query!
Country [427]
0
0
Spain
Query!
State/province [427]
0
0
Girona
Query!
Country [428]
0
0
Spain
Query!
State/province [428]
0
0
Islas Baleares
Query!
Country [429]
0
0
Spain
Query!
State/province [429]
0
0
Madrid
Query!
Country [430]
0
0
Spain
Query!
State/province [430]
0
0
Malaga
Query!
Country [431]
0
0
Spain
Query!
State/province [431]
0
0
Murcia
Query!
Country [432]
0
0
Spain
Query!
State/province [432]
0
0
Navarra
Query!
Country [433]
0
0
Spain
Query!
State/province [433]
0
0
Santa Cruz De Tenerife
Query!
Country [434]
0
0
Spain
Query!
State/province [434]
0
0
Sevilla
Query!
Country [435]
0
0
Spain
Query!
State/province [435]
0
0
Ferrol
Query!
Country [436]
0
0
Spain
Query!
State/province [436]
0
0
Huelva
Query!
Country [437]
0
0
Spain
Query!
State/province [437]
0
0
Las Palmas de Gran Canaria
Query!
Country [438]
0
0
Spain
Query!
State/province [438]
0
0
Tarragona
Query!
Country [439]
0
0
Spain
Query!
State/province [439]
0
0
Zaragoza
Query!
Country [440]
0
0
Sweden
Query!
State/province [440]
0
0
Skane Lan
Query!
Country [441]
0
0
Sweden
Query!
State/province [441]
0
0
Goteborg
Query!
Country [442]
0
0
Sweden
Query!
State/province [442]
0
0
Linkoping
Query!
Country [443]
0
0
Sweden
Query!
State/province [443]
0
0
Lund
Query!
Country [444]
0
0
Sweden
Query!
State/province [444]
0
0
Solna
Query!
Country [445]
0
0
Sweden
Query!
State/province [445]
0
0
Stockholm
Query!
Country [446]
0
0
Sweden
Query!
State/province [446]
0
0
Uppsala
Query!
Country [447]
0
0
Sweden
Query!
State/province [447]
0
0
Vasteras
Query!
Country [448]
0
0
Switzerland
Query!
State/province [448]
0
0
Basel
Query!
Country [449]
0
0
Switzerland
Query!
State/province [449]
0
0
Bern
Query!
Country [450]
0
0
Switzerland
Query!
State/province [450]
0
0
Geneve 14
Query!
Country [451]
0
0
Switzerland
Query!
State/province [451]
0
0
Lugano
Query!
Country [452]
0
0
Switzerland
Query!
State/province [452]
0
0
Luzern 16
Query!
Country [453]
0
0
Taiwan
Query!
State/province [453]
0
0
Taiwan ROC
Query!
Country [454]
0
0
Taiwan
Query!
State/province [454]
0
0
Changhua
Query!
Country [455]
0
0
Taiwan
Query!
State/province [455]
0
0
Kaohsiung
Query!
Country [456]
0
0
Taiwan
Query!
State/province [456]
0
0
Taichung
Query!
Country [457]
0
0
Taiwan
Query!
State/province [457]
0
0
Tainan
Query!
Country [458]
0
0
Taiwan
Query!
State/province [458]
0
0
Taipei
Query!
Country [459]
0
0
Taiwan
Query!
State/province [459]
0
0
Taoyuan
Query!
Country [460]
0
0
Thailand
Query!
State/province [460]
0
0
Songkla
Query!
Country [461]
0
0
Thailand
Query!
State/province [461]
0
0
THA
Query!
Country [462]
0
0
Thailand
Query!
State/province [462]
0
0
Bangkok
Query!
Country [463]
0
0
Thailand
Query!
State/province [463]
0
0
Chiang Mai
Query!
Country [464]
0
0
Thailand
Query!
State/province [464]
0
0
Muang
Query!
Country [465]
0
0
Thailand
Query!
State/province [465]
0
0
Ubon Ratchathani
Query!
Country [466]
0
0
Turkey
Query!
State/province [466]
0
0
Bornova
Query!
Country [467]
0
0
Turkey
Query!
State/province [467]
0
0
Eskisehir
Query!
Country [468]
0
0
Turkey
Query!
State/province [468]
0
0
Ankara
Query!
Country [469]
0
0
Turkey
Query!
State/province [469]
0
0
Denizli
Query!
Country [470]
0
0
Turkey
Query!
State/province [470]
0
0
Gaziantep
Query!
Country [471]
0
0
Turkey
Query!
State/province [471]
0
0
Haydarpasa Istanbul
Query!
Country [472]
0
0
Turkey
Query!
State/province [472]
0
0
Istanbul
Query!
Country [473]
0
0
Turkey
Query!
State/province [473]
0
0
Izmir
Query!
Country [474]
0
0
Turkey
Query!
State/province [474]
0
0
Kucukcekmece Istanbul
Query!
Country [475]
0
0
Turkey
Query!
State/province [475]
0
0
Mersin
Query!
Country [476]
0
0
Turkey
Query!
State/province [476]
0
0
Mugla
Query!
Country [477]
0
0
Turkey
Query!
State/province [477]
0
0
Talas / Kayseri
Query!
Country [478]
0
0
United Kingdom
Query!
State/province [478]
0
0
Beds
Query!
Country [479]
0
0
United Kingdom
Query!
State/province [479]
0
0
Buckinghamshire
Query!
Country [480]
0
0
United Kingdom
Query!
State/province [480]
0
0
Cambridgeshire
Query!
Country [481]
0
0
United Kingdom
Query!
State/province [481]
0
0
Cleveland
Query!
Country [482]
0
0
United Kingdom
Query!
State/province [482]
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London
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Vietnam
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Summary
Brief summary
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
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Trial website
https://clinicaltrials.gov/study/NCT05739383
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Contacts
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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1-888-669-6682
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT05739383
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