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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07000357




Registration number
NCT07000357
Ethics application status
Date submitted
30/05/2025
Date registered
2/06/2025
Date last updated
2/06/2025

Titles & IDs
Public title
A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event
Scientific title
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event
Secondary ID [1] 0 0
2025-520519-14
Secondary ID [2] 0 0
D7960C00015
Universal Trial Number (UTN)
Trial acronym
AZURE-Outcomes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD0780
Treatment: Drugs - Placebo

Experimental: AZD0780 - Participants will receive oral AZD0780 once daily

Placebo comparator: Placebo - Participants will receive oral placebo once daily


Treatment: Drugs: AZD0780
Participants will receive oral AZD0780 once daily

Treatment: Drugs: Placebo
Participants will receive oral placebo once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first event of any component of MACE-PLUS
Timepoint [1] 0 0
Up to approximately 54 months
Secondary outcome [1] 0 0
Time to first event of any component of 3P MACE
Timepoint [1] 0 0
Up to approximately 54 months
Secondary outcome [2] 0 0
Time to first event of any component of MACE PLUS
Timepoint [2] 0 0
Up to approximately 54 months
Secondary outcome [3] 0 0
Time to first event of MI
Timepoint [3] 0 0
Up to approximately 54 months
Secondary outcome [4] 0 0
Time to first event of urgent coronary revascularisation
Timepoint [4] 0 0
Up to approximately 54 months
Secondary outcome [5] 0 0
Time to CV death
Timepoint [5] 0 0
Up to approximately 54 months
Secondary outcome [6] 0 0
Time to first event of MALE
Timepoint [6] 0 0
Up to approximately 54 months
Secondary outcome [7] 0 0
Time to all-cause mortality
Timepoint [7] 0 0
Up to approximately 54 months

Eligibility
Key inclusion criteria
* Meets one of the following:

1. Participants with history of an ASCVD event: Participants = 18 years of age at the time of signing the ICF with a history of ASCVD defined as ACS within 1 to 12 months prior to randomisation, or large artery ischaemic stroke suspected to be due to atherosclerotic vascular disease within 1 to 12 months prior to randomisation, or revascularisation for symptomatic lower limb PAD, and LDL-C = 60 mg/dL (= 1.55 mmol/L).

Additional risk factors based on the level of the screening LDL-C:

o Participants with an LDL-C = 75 mg/dL (= 1.9 mmol/L) need to have at least one of the other additional risk factors below.
* T2DM requiring ongoing medical therapy
* Age = 65 years
* Previous above ankle amputation due to PAD
* Previous diagnosis of non-end stage CKD
2. Participants at increased risk of a first ASCVD event: Male participant = 50 years of age or female participant = 55 years of age at the time of signing the ICF with LDL-C = 100 mg/dL (= 2.6 mmol/L) and diagnostic evidence of at least one of the following disease categories (i, ii, or iii):

i) Significant atherosclerotic artery disease

ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of end-organ disease (diabetic nephropathy, retinopathy, neuropathy or an ABI outside the normal range [0.9 to 1.4])

iii) Documented atherosclerosis of less significance

For ii) and iii), participants need to have at least one of the additional risk factors below:

1. CKD with eGFR = xx mL/min/1.73 m2
2. Current tobacco use
3. Age = 65
4. T2DM (if included on the less significant atherosclerosis criterion iii)

* Participant should be receiving a maximally tolerated lipid-lowering regimen including a maximally tolerated dose of a statin.

1. Participants who are judged by the treating physician not to tolerate high-intensity statins (according to guidelines, typically, atorvastatin = 40 mg once daily or rosuvastatin = 20 mg once daily) may be included if treated with a low or moderate intensity statin dose.
2. Participants not receiving any statins must have documented intolerable side effects to at least 2 different statins, including one at the lowest standard dose or on a chronic medication that would prohibit the use of a statin (according to the prescribing information for the statin in question).
3. Participants must achieve a stable dose (> 28 days) of lipid-lowering therapies before screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.
* Any revascularisation procedure planned within the next 3 months.
* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.
* Calculated eGFR < 15 mL /min/1.73 m2
* Any laboratory values with the following deviations at screening:

* AST or ALT > 3 × ULN
* TBL > 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin < 1.5 × ULN)
* Fasting triglycerides = 400 mg/dL (= 4.52 mmol/L).
* Creatine kinase > 5 × ULN
* Urine albumin/creatinine ratio = 500 mg/g
* Uncontrolled T2DM defined as HbA1c = 9.5% at screening.
* Inadequately treated hypothyroidism defined as TSH > 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.
* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.
* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.
* Use of PCSK9 inhibitors: evolocumab/alirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.

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 administering the treatment/s
The people assessing the outcomes
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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
6/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/10/2029
Actual
Sample size
Target
15100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Country [205] 0 0
Greece
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Thessaloniki
Country [206] 0 0
Hungary
State/province [206] 0 0
Balatonfüred
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Hungary
State/province [207] 0 0
Budapest
Country [208] 0 0
Hungary
State/province [208] 0 0
Békéscsaba
Country [209] 0 0
Hungary
State/province [209] 0 0
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Country [210] 0 0
Hungary
State/province [210] 0 0
Encs
Country [211] 0 0
Hungary
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Country [212] 0 0
Hungary
State/province [212] 0 0
Kaposvár
Country [213] 0 0
Hungary
State/province [213] 0 0
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Country [214] 0 0
Hungary
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Nyíregyháza
Country [215] 0 0
Hungary
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Country [216] 0 0
Hungary
State/province [216] 0 0
Szeged
Country [217] 0 0
Hungary
State/province [217] 0 0
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Country [218] 0 0
Hungary
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Szolnok
Country [219] 0 0
Hungary
State/province [219] 0 0
Székesfehérvár
Country [220] 0 0
Hungary
State/province [220] 0 0
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Country [221] 0 0
Hungary
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Country [222] 0 0
India
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Ahamadabad
Country [223] 0 0
India
State/province [223] 0 0
Bangalore
Country [224] 0 0
India
State/province [224] 0 0
Belagavi
Country [225] 0 0
India
State/province [225] 0 0
Dehradun
Country [226] 0 0
India
State/province [226] 0 0
Delhi
Country [227] 0 0
India
State/province [227] 0 0
Dwarka
Country [228] 0 0
India
State/province [228] 0 0
Gurgaon
Country [229] 0 0
India
State/province [229] 0 0
Hydarabad
Country [230] 0 0
India
State/province [230] 0 0
Hyderabad
Country [231] 0 0
India
State/province [231] 0 0
Kanpur
Country [232] 0 0
India
State/province [232] 0 0
Kochi
Country [233] 0 0
India
State/province [233] 0 0
Kolkata
Country [234] 0 0
India
State/province [234] 0 0
Ludhiana
Country [235] 0 0
India
State/province [235] 0 0
Manipal
Country [236] 0 0
India
State/province [236] 0 0
Mumbai
Country [237] 0 0
India
State/province [237] 0 0
Nagpur
Country [238] 0 0
India
State/province [238] 0 0
New Dehli
Country [239] 0 0
India
State/province [239] 0 0
New Delhi
Country [240] 0 0
India
State/province [240] 0 0
Vadodara
Country [241] 0 0
India
State/province [241] 0 0
Vijayawada
Country [242] 0 0
Italy
State/province [242] 0 0
Arzignano
Country [243] 0 0
Italy
State/province [243] 0 0
Bergamo
Country [244] 0 0
Italy
State/province [244] 0 0
Bologna
Country [245] 0 0
Italy
State/province [245] 0 0
Brescia
Country [246] 0 0
Italy
State/province [246] 0 0
Caserta
Country [247] 0 0
Italy
State/province [247] 0 0
Catania
Country [248] 0 0
Italy
State/province [248] 0 0
Cona
Country [249] 0 0
Italy
State/province [249] 0 0
Foggia
Country [250] 0 0
Italy
State/province [250] 0 0
Genoa
Country [251] 0 0
Italy
State/province [251] 0 0
Lecco
Country [252] 0 0
Italy
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Milano
Country [253] 0 0
Italy
State/province [253] 0 0
Napoli
Country [254] 0 0
Italy
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Novara
Country [255] 0 0
Italy
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Parma
Country [256] 0 0
Italy
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Pavia
Country [257] 0 0
Italy
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Perugia
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Italy
State/province [258] 0 0
Pordenone
Country [259] 0 0
Italy
State/province [259] 0 0
Rivoli
Country [260] 0 0
Italy
State/province [260] 0 0
Roma
Country [261] 0 0
Italy
State/province [261] 0 0
Rozzano
Country [262] 0 0
Italy
State/province [262] 0 0
Torino
Country [263] 0 0
Japan
State/province [263] 0 0
Ami-machi
Country [264] 0 0
Japan
State/province [264] 0 0
Asahi-shi
Country [265] 0 0
Japan
State/province [265] 0 0
Fujisawa-shi
Country [266] 0 0
Japan
State/province [266] 0 0
Hamamatsu-shi
Country [267] 0 0
Japan
State/province [267] 0 0
Higashiyamato-shi
Country [268] 0 0
Japan
State/province [268] 0 0
Hiroshima-shi
Country [269] 0 0
Japan
State/province [269] 0 0
Ichikawa-shi
Country [270] 0 0
Japan
State/province [270] 0 0
Kamakura
Country [271] 0 0
Japan
State/province [271] 0 0
Kanazawa-shi
Country [272] 0 0
Japan
State/province [272] 0 0
Kanoya-shi
Country [273] 0 0
Japan
State/province [273] 0 0
Kasuya-gun
Country [274] 0 0
Japan
State/province [274] 0 0
Kishiwada-shi
Country [275] 0 0
Japan
State/province [275] 0 0
Kitakyushu
Country [276] 0 0
Japan
State/province [276] 0 0
Kobe-shi
Country [277] 0 0
Japan
State/province [277] 0 0
Kobe
Country [278] 0 0
Japan
State/province [278] 0 0
Koga-shi
Country [279] 0 0
Japan
State/province [279] 0 0
Komatsu-shi
Country [280] 0 0
Japan
State/province [280] 0 0
Kure-shi
Country [281] 0 0
Japan
State/province [281] 0 0
Kyoto-shi
Country [282] 0 0
Japan
State/province [282] 0 0
Matsuyama-city
Country [283] 0 0
Japan
State/province [283] 0 0
Minato-ku
Country [284] 0 0
Japan
State/province [284] 0 0
Miyakonojo-shi
Country [285] 0 0
Japan
State/province [285] 0 0
Miyazaki
Country [286] 0 0
Japan
State/province [286] 0 0
Nagasaki-shi
Country [287] 0 0
Japan
State/province [287] 0 0
Niigata-shi
Country [288] 0 0
Japan
State/province [288] 0 0
Obu
Country [289] 0 0
Japan
State/province [289] 0 0
Oita-shi
Country [290] 0 0
Japan
State/province [290] 0 0
Okayama-shi
Country [291] 0 0
Japan
State/province [291] 0 0
Omura-shi
Country [292] 0 0
Japan
State/province [292] 0 0
Osaka-shi
Country [293] 0 0
Japan
State/province [293] 0 0
Suita-shi
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Japan
State/province [294] 0 0
Suwa-shi
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Japan
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Tamana-shi
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Japan
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Tanabe-shi
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Japan
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Tokushima-shi
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Japan
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Toride-shi
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Japan
State/province [299] 0 0
Tsukuba-shi
Country [300] 0 0
Japan
State/province [300] 0 0
Urasoe-Shi
Country [301] 0 0
Japan
State/province [301] 0 0
Urayasu-shi
Country [302] 0 0
Japan
State/province [302] 0 0
Ushiku-shi
Country [303] 0 0
Japan
State/province [303] 0 0
Utsunomiya-shi
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Japan
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Yokohama City
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Japan
State/province [305] 0 0
Yokohama-shi
Country [306] 0 0
Korea, Republic of
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Bucheon-si
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Korea, Republic of
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Busan
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Korea, Republic of
State/province [308] 0 0
Changwon-si
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Korea, Republic of
State/province [309] 0 0
Daegu
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Korea, Republic of
State/province [310] 0 0
Daejeon
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Korea, Republic of
State/province [311] 0 0
Goyang-si
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Korea, Republic of
State/province [312] 0 0
Gwangju
Country [313] 0 0
Korea, Republic of
State/province [313] 0 0
Gwangmyeong-si
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Korea, Republic of
State/province [314] 0 0
Jung-gu
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Korea, Republic of
State/province [315] 0 0
Seoul
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Korea, Republic of
State/province [316] 0 0
Suncheon
Country [317] 0 0
Korea, Republic of
State/province [317] 0 0
Yongin-si
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Malaysia
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Alor Setar
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Malaysia
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George Town
Country [320] 0 0
Malaysia
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Kajang
Country [321] 0 0
Malaysia
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Kota Kinabalu
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Malaysia
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Kota Samarahan
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Malaysia
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Malaysia
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Kuala Terengganu
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Malaysia
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Kuantan
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Malaysia
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Kuching
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Malaysia
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Malaysia
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Seri Manjung
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Mexico
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New Zealand
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Peru
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Chorrillos
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Peru
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Peru
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Peru
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Peru
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Country [344] 0 0
Philippines
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Baguio City
Country [345] 0 0
Philippines
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Country [346] 0 0
Philippines
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Davao
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Philippines
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Iloilo City
Country [348] 0 0
Philippines
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Laguna
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Philippines
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Manadaluyong City
Country [350] 0 0
Philippines
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Manila
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Philippines
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Marikina
Country [352] 0 0
Philippines
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Quezon City
Country [353] 0 0
Philippines
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Tacloban City
Country [354] 0 0
Poland
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Bialystok
Country [355] 0 0
Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Jelenia Góra
Country [359] 0 0
Poland
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Katowice
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Poland
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Kraków
Country [361] 0 0
Poland
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Kedzierzyn-Kozle
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Poland
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Lublin
Country [363] 0 0
Poland
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Ostrów Mazowiecka
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Poland
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Poznan
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Poland
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Plock
Country [366] 0 0
Poland
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Ruda Slaska
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Poland
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Rzeszów
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Poland
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Szczecin
Country [369] 0 0
Poland
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Tarnów
Country [370] 0 0
Poland
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Torun
Country [371] 0 0
Poland
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Country [372] 0 0
Poland
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Wroclaw
Country [373] 0 0
Poland
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Lódz
Country [374] 0 0
Romania
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Arad
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Romania
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Bacau
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Romania
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Bucharest
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Romania
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Bucuresti
Country [378] 0 0
Romania
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Romania
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Iasi
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Romania
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Oradea
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Romania
State/province [381] 0 0
Satu Mare
Country [382] 0 0
Romania
State/province [382] 0 0
Targu Mures
Country [383] 0 0
Romania
State/province [383] 0 0
Timisoara
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Romania
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Tirgu-Mures
Country [385] 0 0
Slovakia
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Bratislava
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Slovakia
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Brezno
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Slovakia
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Dolný Kubín
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Slovakia
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Kosice
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Slovakia
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Košice
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Slovakia
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Levice
Country [391] 0 0
Slovakia
State/province [391] 0 0
Malacky
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Slovakia
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Nitra
Country [393] 0 0
Slovakia
State/province [393] 0 0
Presov
Country [394] 0 0
Slovakia
State/province [394] 0 0
Prešov
Country [395] 0 0
Slovakia
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Trnava
Country [396] 0 0
Slovakia
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Vinica
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Slovakia
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Zilina
Country [398] 0 0
Slovakia
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Country [399] 0 0
South Africa
State/province [399] 0 0
Bellville
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South Africa
State/province [400] 0 0
Benoni
Country [401] 0 0
South Africa
State/province [401] 0 0
Bloemfontein
Country [402] 0 0
South Africa
State/province [402] 0 0
Brackenfell
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South Africa
State/province [403] 0 0
Cape Town
Country [404] 0 0
South Africa
State/province [404] 0 0
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South Africa
State/province [405] 0 0
Durban
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South Africa
State/province [406] 0 0
George
Country [407] 0 0
South Africa
State/province [407] 0 0
Johannesburg
Country [408] 0 0
South Africa
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Kimberley
Country [409] 0 0
South Africa
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Midrand
Country [410] 0 0
South Africa
State/province [410] 0 0
Paarl
Country [411] 0 0
South Africa
State/province [411] 0 0
Pretoria
Country [412] 0 0
South Africa
State/province [412] 0 0
Somerset West
Country [413] 0 0
South Africa
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Umhlanga Rocks
Country [414] 0 0
South Africa
State/province [414] 0 0
Umkomaas
Country [415] 0 0
Spain
State/province [415] 0 0
A Coruna
Country [416] 0 0
Spain
State/province [416] 0 0
Alicante
Country [417] 0 0
Spain
State/province [417] 0 0
Barcelona
Country [418] 0 0
Spain
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Madrid
Country [419] 0 0
Spain
State/province [419] 0 0
Murcia
Country [420] 0 0
Spain
State/province [420] 0 0
Málaga
Country [421] 0 0
Spain
State/province [421] 0 0
Palma de Mallorca
Country [422] 0 0
Spain
State/province [422] 0 0
Sanlúcar De Barrameda (Cádiz)
Country [423] 0 0
Spain
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Santiago(A Coruña)
Country [424] 0 0
Spain
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Country [425] 0 0
Spain
State/province [425] 0 0
Tarragona
Country [426] 0 0
Spain
State/province [426] 0 0
Valencia
Country [427] 0 0
Spain
State/province [427] 0 0
Vigo
Country [428] 0 0
Spain
State/province [428] 0 0
Villamartín (Cádiz)
Country [429] 0 0
Sweden
State/province [429] 0 0
Alingsås
Country [430] 0 0
Sweden
State/province [430] 0 0
Falun
Country [431] 0 0
Sweden
State/province [431] 0 0
Huddinge
Country [432] 0 0
Sweden
State/province [432] 0 0
Lund
Country [433] 0 0
Sweden
State/province [433] 0 0
Stockholm
Country [434] 0 0
Sweden
State/province [434] 0 0
Umea
Country [435] 0 0
Sweden
State/province [435] 0 0
Uppsala
Country [436] 0 0
Sweden
State/province [436] 0 0
Västerås
Country [437] 0 0
Taiwan
State/province [437] 0 0
Changhua
Country [438] 0 0
Taiwan
State/province [438] 0 0
Hsinchu
Country [439] 0 0
Taiwan
State/province [439] 0 0
Hualien City
Country [440] 0 0
Taiwan
State/province [440] 0 0
Kaohsiung City
Country [441] 0 0
Taiwan
State/province [441] 0 0
Kaohsiung
Country [442] 0 0
Taiwan
State/province [442] 0 0
New Taipei
Country [443] 0 0
Taiwan
State/province [443] 0 0
Taichung City
Country [444] 0 0
Taiwan
State/province [444] 0 0
Taichung
Country [445] 0 0
Taiwan
State/province [445] 0 0
Tainan
Country [446] 0 0
Taiwan
State/province [446] 0 0
Taipei City
Country [447] 0 0
Taiwan
State/province [447] 0 0
Taipei
Country [448] 0 0
Taiwan
State/province [448] 0 0
Taoyuan
Country [449] 0 0
Taiwan
State/province [449] 0 0
Yilan
Country [450] 0 0
Thailand
State/province [450] 0 0
Bangkok
Country [451] 0 0
Thailand
State/province [451] 0 0
Banphaeo
Country [452] 0 0
Thailand
State/province [452] 0 0
Chiang Mai
Country [453] 0 0
Thailand
State/province [453] 0 0
Hat Yai
Country [454] 0 0
Thailand
State/province [454] 0 0
Khon-Kaen
Country [455] 0 0
Thailand
State/province [455] 0 0
Klong Luang
Country [456] 0 0
Thailand
State/province [456] 0 0
Mueang
Country [457] 0 0
Thailand
State/province [457] 0 0
Nakhon Ratchasima
Country [458] 0 0
Turkey
State/province [458] 0 0
Afyonkarahisar
Country [459] 0 0
Turkey
State/province [459] 0 0
Ankara
Country [460] 0 0
Turkey
State/province [460] 0 0
Antalya
Country [461] 0 0
Turkey
State/province [461] 0 0
Canakkale
Country [462] 0 0
Turkey
State/province [462] 0 0
Edirne
Country [463] 0 0
Turkey
State/province [463] 0 0
Istanbul
Country [464] 0 0
Turkey
State/province [464] 0 0
Izmir
Country [465] 0 0
Turkey
State/province [465] 0 0
Kayseri
Country [466] 0 0
Turkey
State/province [466] 0 0
Kazimkarabekir
Country [467] 0 0
Turkey
State/province [467] 0 0
Kütahya
Country [468] 0 0
Turkey
State/province [468] 0 0
Mugla
Country [469] 0 0
Turkey
State/province [469] 0 0
Odunpazari
Country [470] 0 0
Turkey
State/province [470] 0 0
Tokat
Country [471] 0 0
Turkey
State/province [471] 0 0
Yenimahalle
Country [472] 0 0
Ukraine
State/province [472] 0 0
Chernivtsi
Country [473] 0 0
Ukraine
State/province [473] 0 0
Ivano-Frankivsk
Country [474] 0 0
Ukraine
State/province [474] 0 0
Kyiv
Country [475] 0 0
Ukraine
State/province [475] 0 0
Lutsk
Country [476] 0 0
Ukraine
State/province [476] 0 0
Uzhhorod
Country [477] 0 0
Ukraine
State/province [477] 0 0
Vinnytsia
Country [478] 0 0
Ukraine
State/province [478] 0 0
Vinnytsya
Country [479] 0 0
Ukraine
State/province [479] 0 0
Zhytomyr
Country [480] 0 0
United Kingdom
State/province [480] 0 0
Birmingham
Country [481] 0 0
United Kingdom
State/province [481] 0 0
Bristol
Country [482] 0 0
United Kingdom
State/province [482] 0 0
Calow
Country [483] 0 0
United Kingdom
State/province [483] 0 0
Congleton
Country [484] 0 0
United Kingdom
State/province [484] 0 0
Dundee
Country [485] 0 0
United Kingdom
State/province [485] 0 0
Gateshead
Country [486] 0 0
United Kingdom
State/province [486] 0 0
Glasgow
Country [487] 0 0
United Kingdom
State/province [487] 0 0
Harefield
Country [488] 0 0
United Kingdom
State/province [488] 0 0
King's Lynn
Country [489] 0 0
United Kingdom
State/province [489] 0 0
London
Country [490] 0 0
United Kingdom
State/province [490] 0 0
Middlesex
Country [491] 0 0
United Kingdom
State/province [491] 0 0
Milton Keynes
Country [492] 0 0
United Kingdom
State/province [492] 0 0
Poole
Country [493] 0 0
United Kingdom
State/province [493] 0 0
Sheffield
Country [494] 0 0
United Kingdom
State/province [494] 0 0
Wirral
Country [495] 0 0
Vietnam
State/province [495] 0 0
Can Tho
Country [496] 0 0
Vietnam
State/province [496] 0 0
Danang
Country [497] 0 0
Vietnam
State/province [497] 0 0
Hai Phong
Country [498] 0 0
Vietnam
State/province [498] 0 0
Ho Chi Minh City
Country [499] 0 0
Vietnam
State/province [499] 0 0
Ho Chi Minh
Country [500] 0 0
Vietnam
State/province [500] 0 0
Hue

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT07000357