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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06677060




Registration number
NCT06677060
Ethics application status
Date submitted
5/11/2024
Date registered
6/11/2024
Date last updated
29/06/2025

Titles & IDs
Public title
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Scientific title
A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death
Secondary ID [1] 0 0
2024-514506-32-00
Secondary ID [2] 0 0
D6973C00001
Universal Trial Number (UTN)
Trial acronym
Prevent-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Baxdrostat and dapagliflozin
Other interventions - Placebo and dapagliflozin

Experimental: Baxdrostat/Dapagliflozin - Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.

Experimental: Placebo/Dapagliflozin - Patients will receive a dose of dapagliflozin in combination with matching placebo


Treatment: Drugs: Baxdrostat and dapagliflozin
baxdrostat tablet and dapagliflozin tablet

Other interventions: Placebo and dapagliflozin
placebo tablet and dapagliflozin tablet
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death
Timepoint [1] 0 0
Event driven; Up to 38 months
Secondary outcome [1] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of hospitalisation for HF or CV death
Timepoint [1] 0 0
Event driven; Up to 38 months
Secondary outcome [2] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of HF events
Timepoint [2] 0 0
Event driven; Up to 38 months
Secondary outcome [3] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death
Timepoint [3] 0 0
Event driven; Up to 38 months
Secondary outcome [4] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of all-cause mortality
Timepoint [4] 0 0
Event driven; Up to 38 months
Secondary outcome [5] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of stroke or CV death
Timepoint [5] 0 0
Event driven; Up to 38 months
Secondary outcome [6] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of atrial fibrillation or CV death in participants without history of atrial fibrillation at baseline
Timepoint [6] 0 0
Event driven; Up to 38 months
Secondary outcome [7] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MI or CV death
Timepoint [7] 0 0
Event driven; Up to 38 months

Eligibility
Key inclusion criteria
1. Participants of any sex and gender must be = 40 years old at the time of signing the informed consent.
2. Diagnosed with T2DM and requiring treatment
3. Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)
4. History of HTN and an SBP = 130 mmHg at screening and = 120 mmHg at the Randomisation Visit.
5. Central laboratory serum potassium must meet the following criteria at the Screening

Visit, based on screening eGFR:
* for participants with screening eGFR = 45 mL/min/1.73 m2, potassium must be

= 3.0 and = 4.8 mmol/L at the Screening Visit
* for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be = 3.0 and = 4.5 mmol/L at the Screening Visit
6. At least one additional risk factor for HF:

* Age = 70 years
* UACR > 20 mg/g
* eGFR < 60 mL/min/1.73 m2
* History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease)
* History of atrial fibrillation or atrial flutter
* NT-proBNP > 125 ng/L
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previously confirmed diagnosis and treatment of heart failure
2. An eGFR < 30 mL/min/1.73 m2 at screening
3. Known hyperkalaemia, defined as potassium = 5.5 mmol/L within 3 months prior to screening
4. Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) at screening
5. Serum sodium < 135 mmol/L at screening, determined as per central laboratory assessment
6. Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation
7. Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation
8. Percutaneous coronary intervention within 1 month prior to randomisation
9. Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
10. Documented history of adrenal insufficiency
11. Any dialysis (including for acute kidney injury) within 3 months prior to screening
12. Any acute kidney injury within 3 months prior to screening
13. History or known allergy/hypersensitivity to the study treatment, as judged by the Investigator (eg, SGLT2i or active substance or excipients)
14. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant)
15. Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to screening)
16. Drug or alcohol abuse that in the Investigator's judgement makes the participant a poor candidate for the study
17. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone) or aldosterone synthase inhibitor within 4 weeks prior to screening and/or during the study
18. Concomitant therapy with strong inducers of cytochrome P450
19. Use of potassium-sparing diuretics (such as triamterene or amiloride) and direct renin inhibitor (eg, aliskiren) at the time of screening
20. Use of potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening

Study design
Purpose of the study
Prevention
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/12/2029
Actual
Sample size
Target
11300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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Research Site - Adelaide
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Research Site - Elizabeth Vale
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5000 - Adelaide
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5112 - Elizabeth Vale
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6160 - Fremantle
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3220 - Geelong
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2747 - Kingswood
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5068 - Leabrook
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2035 - Maroubra
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2291 - Merewether
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4064 - Milton
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3170 - Mulgrave
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6017 - Osborne Park
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4700 - Rockhampton
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2500 - Wollongong
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Germany
State/province [189] 0 0
Bad Oeynhausen
Country [190] 0 0
Germany
State/province [190] 0 0
Bamberg
Country [191] 0 0
Germany
State/province [191] 0 0
Bechhofen
Country [192] 0 0
Germany
State/province [192] 0 0
Berlin
Country [193] 0 0
Germany
State/province [193] 0 0
Bochum
Country [194] 0 0
Germany
State/province [194] 0 0
Bremen
Country [195] 0 0
Germany
State/province [195] 0 0
Deggingen
Country [196] 0 0
Germany
State/province [196] 0 0
Dresden
Country [197] 0 0
Germany
State/province [197] 0 0
Elsterwerda
Country [198] 0 0
Germany
State/province [198] 0 0
Essen
Country [199] 0 0
Germany
State/province [199] 0 0
Frankfurt
Country [200] 0 0
Germany
State/province [200] 0 0
Freiburg
Country [201] 0 0
Germany
State/province [201] 0 0
Friedrichsthal
Country [202] 0 0
Germany
State/province [202] 0 0
Fulda
Country [203] 0 0
Germany
State/province [203] 0 0
Gelnhausen
Country [204] 0 0
Germany
State/province [204] 0 0
Görlitz
Country [205] 0 0
Germany
State/province [205] 0 0
Hamburg
Country [206] 0 0
Germany
State/province [206] 0 0
Haßloch
Country [207] 0 0
Germany
State/province [207] 0 0
Heidelberg
Country [208] 0 0
Germany
State/province [208] 0 0
Homburg
Country [209] 0 0
Germany
State/province [209] 0 0
Kaiserslautern
Country [210] 0 0
Germany
State/province [210] 0 0
Kassel
Country [211] 0 0
Germany
State/province [211] 0 0
Köln
Country [212] 0 0
Germany
State/province [212] 0 0
Langen
Country [213] 0 0
Germany
State/province [213] 0 0
Leipzig
Country [214] 0 0
Germany
State/province [214] 0 0
Ludwigshafen
Country [215] 0 0
Germany
State/province [215] 0 0
Mannheim
Country [216] 0 0
Germany
State/province [216] 0 0
Markkleeberg
Country [217] 0 0
Germany
State/province [217] 0 0
Munich
Country [218] 0 0
Germany
State/province [218] 0 0
Münster
Country [219] 0 0
Germany
State/province [219] 0 0
Naunhof
Country [220] 0 0
Germany
State/province [220] 0 0
Neuruppin
Country [221] 0 0
Germany
State/province [221] 0 0
Nittendorf
Country [222] 0 0
Germany
State/province [222] 0 0
Obertshausen
Country [223] 0 0
Germany
State/province [223] 0 0
Oldenburg
Country [224] 0 0
Germany
State/province [224] 0 0
Osnabrück
Country [225] 0 0
Germany
State/province [225] 0 0
Papenburg
Country [226] 0 0
Germany
State/province [226] 0 0
Pirna
Country [227] 0 0
Germany
State/province [227] 0 0
Potsdam
Country [228] 0 0
Germany
State/province [228] 0 0
Reinfeld (Holstein)
Country [229] 0 0
Germany
State/province [229] 0 0
Völklingen
Country [230] 0 0
Germany
State/province [230] 0 0
Wallerfing
Country [231] 0 0
Germany
State/province [231] 0 0
Wangen
Country [232] 0 0
Germany
State/province [232] 0 0
Weinheim
Country [233] 0 0
Germany
State/province [233] 0 0
Zwenkau
Country [234] 0 0
Greece
State/province [234] 0 0
Athens
Country [235] 0 0
Greece
State/province [235] 0 0
Chania
Country [236] 0 0
Greece
State/province [236] 0 0
Ioannina
Country [237] 0 0
Greece
State/province [237] 0 0
Larissa
Country [238] 0 0
Greece
State/province [238] 0 0
Piraeus
Country [239] 0 0
Greece
State/province [239] 0 0
Thessaloniki
Country [240] 0 0
Hungary
State/province [240] 0 0
Balatonfüred
Country [241] 0 0
Hungary
State/province [241] 0 0
Budapest
Country [242] 0 0
Hungary
State/province [242] 0 0
Békéscsaba
Country [243] 0 0
Hungary
State/province [243] 0 0
Debrecen
Country [244] 0 0
Hungary
State/province [244] 0 0
Gyöngyös
Country [245] 0 0
Hungary
State/province [245] 0 0
Kalocsa
Country [246] 0 0
Hungary
State/province [246] 0 0
Nyíregyháza-Sóstóhegy
Country [247] 0 0
Hungary
State/province [247] 0 0
Nyíregyháza
Country [248] 0 0
Hungary
State/province [248] 0 0
Orosháza
Country [249] 0 0
Hungary
State/province [249] 0 0
Pécs
Country [250] 0 0
Hungary
State/province [250] 0 0
Szeged
Country [251] 0 0
Hungary
State/province [251] 0 0
Szigetvár
Country [252] 0 0
Hungary
State/province [252] 0 0
Szolnok
Country [253] 0 0
Hungary
State/province [253] 0 0
Székesfehérvár
Country [254] 0 0
India
State/province [254] 0 0
Ahmedabad
Country [255] 0 0
India
State/province [255] 0 0
Ajmer
Country [256] 0 0
India
State/province [256] 0 0
Bangalore
Country [257] 0 0
India
State/province [257] 0 0
Belagavi
Country [258] 0 0
India
State/province [258] 0 0
Delhi
Country [259] 0 0
India
State/province [259] 0 0
Gurgaon
Country [260] 0 0
India
State/province [260] 0 0
Hyderabad
Country [261] 0 0
India
State/province [261] 0 0
Karamsad
Country [262] 0 0
India
State/province [262] 0 0
Kolkata
Country [263] 0 0
India
State/province [263] 0 0
Lucknow
Country [264] 0 0
India
State/province [264] 0 0
Nagpur
Country [265] 0 0
India
State/province [265] 0 0
New Delhi
Country [266] 0 0
India
State/province [266] 0 0
Surat
Country [267] 0 0
India
State/province [267] 0 0
Vijayawada
Country [268] 0 0
Israel
State/province [268] 0 0
Be'er Ya'akov
Country [269] 0 0
Israel
State/province [269] 0 0
Beer Sheba
Country [270] 0 0
Israel
State/province [270] 0 0
Haifa
Country [271] 0 0
Israel
State/province [271] 0 0
Herzelia
Country [272] 0 0
Israel
State/province [272] 0 0
Holon
Country [273] 0 0
Israel
State/province [273] 0 0
Jerusalem
Country [274] 0 0
Israel
State/province [274] 0 0
Petah Tikva
Country [275] 0 0
Israel
State/province [275] 0 0
Ramat Gan
Country [276] 0 0
Israel
State/province [276] 0 0
Tel Aviv
Country [277] 0 0
Israel
State/province [277] 0 0
Tel-Aviv
Country [278] 0 0
Italy
State/province [278] 0 0
Alessandria
Country [279] 0 0
Italy
State/province [279] 0 0
Bari
Country [280] 0 0
Italy
State/province [280] 0 0
Bergamo
Country [281] 0 0
Italy
State/province [281] 0 0
Brescia
Country [282] 0 0
Italy
State/province [282] 0 0
Chiavari
Country [283] 0 0
Italy
State/province [283] 0 0
Cona
Country [284] 0 0
Italy
State/province [284] 0 0
Foggia
Country [285] 0 0
Italy
State/province [285] 0 0
Milano
Country [286] 0 0
Italy
State/province [286] 0 0
Milan
Country [287] 0 0
Italy
State/province [287] 0 0
Mondovi
Country [288] 0 0
Italy
State/province [288] 0 0
Monza
Country [289] 0 0
Italy
State/province [289] 0 0
Napoli
Country [290] 0 0
Italy
State/province [290] 0 0
Novara
Country [291] 0 0
Italy
State/province [291] 0 0
Orbassano
Country [292] 0 0
Italy
State/province [292] 0 0
Palermo
Country [293] 0 0
Italy
State/province [293] 0 0
Pavia
Country [294] 0 0
Italy
State/province [294] 0 0
Potenza
Country [295] 0 0
Italy
State/province [295] 0 0
Roma
Country [296] 0 0
Italy
State/province [296] 0 0
Rome
Country [297] 0 0
Italy
State/province [297] 0 0
Rozzano
Country [298] 0 0
Italy
State/province [298] 0 0
Siena
Country [299] 0 0
Italy
State/province [299] 0 0
Torino
Country [300] 0 0
Italy
State/province [300] 0 0
Udine
Country [301] 0 0
Japan
State/province [301] 0 0
Aizu Wakamatsu-shi
Country [302] 0 0
Japan
State/province [302] 0 0
Amagasaki-shi
Country [303] 0 0
Japan
State/province [303] 0 0
Asahikawa-shi
Country [304] 0 0
Japan
State/province [304] 0 0
Azumino-shi
Country [305] 0 0
Japan
State/province [305] 0 0
Hakusan-shi
Country [306] 0 0
Japan
State/province [306] 0 0
Himeji
Country [307] 0 0
Japan
State/province [307] 0 0
Itabashi-ku
Country [308] 0 0
Japan
State/province [308] 0 0
Itabashi
Country [309] 0 0
Japan
State/province [309] 0 0
Izumo-shi
Country [310] 0 0
Japan
State/province [310] 0 0
Kakegawa-shi
Country [311] 0 0
Japan
State/province [311] 0 0
Kamakura-shi
Country [312] 0 0
Japan
State/province [312] 0 0
Kanazawa-shi
Country [313] 0 0
Japan
State/province [313] 0 0
Kawaguchi-shi
Country [314] 0 0
Japan
State/province [314] 0 0
Kishiwada-shi
Country [315] 0 0
Japan
State/province [315] 0 0
Kita-ku
Country [316] 0 0
Japan
State/province [316] 0 0
Kyoto-shi
Country [317] 0 0
Japan
State/province [317] 0 0
Matsudo-shi
Country [318] 0 0
Japan
State/province [318] 0 0
Meguro-ku
Country [319] 0 0
Japan
State/province [319] 0 0
Mito-shi
Country [320] 0 0
Japan
State/province [320] 0 0
Miyazaki-shi
Country [321] 0 0
Japan
State/province [321] 0 0
Nagano
Country [322] 0 0
Japan
State/province [322] 0 0
Ogaki-shi
Country [323] 0 0
Japan
State/province [323] 0 0
Oita-shi
Country [324] 0 0
Japan
State/province [324] 0 0
Osaka-shi
Country [325] 0 0
Japan
State/province [325] 0 0
Osaka
Country [326] 0 0
Japan
State/province [326] 0 0
Saitama-shi
Country [327] 0 0
Japan
State/province [327] 0 0
Sapporo-shi
Country [328] 0 0
Japan
State/province [328] 0 0
Sendai-shi
Country [329] 0 0
Japan
State/province [329] 0 0
Shizuoka-shi
Country [330] 0 0
Japan
State/province [330] 0 0
Suita-shi
Country [331] 0 0
Japan
State/province [331] 0 0
Takamatsu-shi
Country [332] 0 0
Japan
State/province [332] 0 0
Toyota-Shi
Country [333] 0 0
Japan
State/province [333] 0 0
Tsuchiura-shi
Country [334] 0 0
Japan
State/province [334] 0 0
Ueda-shi
Country [335] 0 0
Japan
State/province [335] 0 0
Uwajima-shi
Country [336] 0 0
Japan
State/province [336] 0 0
Yanagawa-shi
Country [337] 0 0
Japan
State/province [337] 0 0
Yokkaichi-shi
Country [338] 0 0
Japan
State/province [338] 0 0
Yokohama-shi
Country [339] 0 0
Korea, Republic of
State/province [339] 0 0
Bucheon-si
Country [340] 0 0
Korea, Republic of
State/province [340] 0 0
Cheongju-si
Country [341] 0 0
Korea, Republic of
State/province [341] 0 0
Daegu
Country [342] 0 0
Korea, Republic of
State/province [342] 0 0
Seongnam-si
Country [343] 0 0
Korea, Republic of
State/province [343] 0 0
Seoul
Country [344] 0 0
Korea, Republic of
State/province [344] 0 0
Suwon-si
Country [345] 0 0
Korea, Republic of
State/province [345] 0 0
Wonju-si
Country [346] 0 0
Korea, Republic of
State/province [346] 0 0
Yangsan-si
Country [347] 0 0
Malaysia
State/province [347] 0 0
Alor Setar
Country [348] 0 0
Malaysia
State/province [348] 0 0
Johor Bahru
Country [349] 0 0
Malaysia
State/province [349] 0 0
Kota Samarahan
Country [350] 0 0
Malaysia
State/province [350] 0 0
Kuantan
Country [351] 0 0
Malaysia
State/province [351] 0 0
Kuching
Country [352] 0 0
Malaysia
State/province [352] 0 0
Malacca
Country [353] 0 0
Malaysia
State/province [353] 0 0
Rawang
Country [354] 0 0
Malaysia
State/province [354] 0 0
Sarawak Miri
Country [355] 0 0
Malaysia
State/province [355] 0 0
Seri Manjung
Country [356] 0 0
Malaysia
State/province [356] 0 0
Sungai Buloh
Country [357] 0 0
Mexico
State/province [357] 0 0
Acapulco
Country [358] 0 0
Mexico
State/province [358] 0 0
Aguascalientes
Country [359] 0 0
Mexico
State/province [359] 0 0
Ciudad de México
Country [360] 0 0
Mexico
State/province [360] 0 0
Cuauhtemoc
Country [361] 0 0
Mexico
State/province [361] 0 0
Cuernavaca
Country [362] 0 0
Mexico
State/province [362] 0 0
Culiacan
Country [363] 0 0
Mexico
State/province [363] 0 0
Culiacán
Country [364] 0 0
Mexico
State/province [364] 0 0
Durango
Country [365] 0 0
Mexico
State/province [365] 0 0
Guadalajara
Country [366] 0 0
Mexico
State/province [366] 0 0
Monterey
Country [367] 0 0
Mexico
State/province [367] 0 0
San Juan del Rio
Country [368] 0 0
Mexico
State/province [368] 0 0
Santiago de Querétaro
Country [369] 0 0
Mexico
State/province [369] 0 0
Veracruz
Country [370] 0 0
Mexico
State/province [370] 0 0
Xalapa
Country [371] 0 0
Mexico
State/province [371] 0 0
Zapopan
Country [372] 0 0
Netherlands
State/province [372] 0 0
Amsterdam
Country [373] 0 0
Netherlands
State/province [373] 0 0
Beek
Country [374] 0 0
Netherlands
State/province [374] 0 0
Den Bosch
Country [375] 0 0
Netherlands
State/province [375] 0 0
Deventer
Country [376] 0 0
Netherlands
State/province [376] 0 0
Ede
Country [377] 0 0
Netherlands
State/province [377] 0 0
Enschede
Country [378] 0 0
Netherlands
State/province [378] 0 0
Groningen
Country [379] 0 0
Netherlands
State/province [379] 0 0
Haarlem
Country [380] 0 0
Netherlands
State/province [380] 0 0
Harderwijk
Country [381] 0 0
Netherlands
State/province [381] 0 0
Hengelo
Country [382] 0 0
Netherlands
State/province [382] 0 0
Hoogeveen
Country [383] 0 0
Netherlands
State/province [383] 0 0
Nijmegen
Country [384] 0 0
Netherlands
State/province [384] 0 0
Roosendaal
Country [385] 0 0
Netherlands
State/province [385] 0 0
Rotterdam
Country [386] 0 0
Netherlands
State/province [386] 0 0
Venlo
Country [387] 0 0
Netherlands
State/province [387] 0 0
Zwolle
Country [388] 0 0
Peru
State/province [388] 0 0
Bellavista
Country [389] 0 0
Peru
State/province [389] 0 0
Chorrillos
Country [390] 0 0
Peru
State/province [390] 0 0
Lima
Country [391] 0 0
Peru
State/province [391] 0 0
LIma
Country [392] 0 0
Peru
State/province [392] 0 0
Piura
Country [393] 0 0
Philippines
State/province [393] 0 0
Angeles City
Country [394] 0 0
Philippines
State/province [394] 0 0
Cebu
Country [395] 0 0
Philippines
State/province [395] 0 0
Davao City
Country [396] 0 0
Philippines
State/province [396] 0 0
Fuente Osmena Cebu City
Country [397] 0 0
Philippines
State/province [397] 0 0
Iloilo City
Country [398] 0 0
Philippines
State/province [398] 0 0
Las Pinas
Country [399] 0 0
Philippines
State/province [399] 0 0
Lipa City
Country [400] 0 0
Philippines
State/province [400] 0 0
Manadaluyong City
Country [401] 0 0
Philippines
State/province [401] 0 0
Puerto Princesa City
Country [402] 0 0
Philippines
State/province [402] 0 0
Quezon City
Country [403] 0 0
Philippines
State/province [403] 0 0
Roxas City
Country [404] 0 0
Poland
State/province [404] 0 0
Biala Podlaska
Country [405] 0 0
Poland
State/province [405] 0 0
Bialystok
Country [406] 0 0
Poland
State/province [406] 0 0
Bydgoszcz
Country [407] 0 0
Poland
State/province [407] 0 0
Chojnice
Country [408] 0 0
Poland
State/province [408] 0 0
Chrzanów
Country [409] 0 0
Poland
State/province [409] 0 0
Czestochowa
Country [410] 0 0
Poland
State/province [410] 0 0
Gdansk
Country [411] 0 0
Poland
State/province [411] 0 0
Gdynia
Country [412] 0 0
Poland
State/province [412] 0 0
Jaslo
Country [413] 0 0
Poland
State/province [413] 0 0
Katowice
Country [414] 0 0
Poland
State/province [414] 0 0
Krakow
Country [415] 0 0
Poland
State/province [415] 0 0
Kraków
Country [416] 0 0
Poland
State/province [416] 0 0
Lublin
Country [417] 0 0
Poland
State/province [417] 0 0
Myszków
Country [418] 0 0
Poland
State/province [418] 0 0
Olsztyn
Country [419] 0 0
Poland
State/province [419] 0 0
Ostrów Mazowiecka
Country [420] 0 0
Poland
State/province [420] 0 0
Piaseczno
Country [421] 0 0
Poland
State/province [421] 0 0
Piekary Slaskie
Country [422] 0 0
Poland
State/province [422] 0 0
Poznan
Country [423] 0 0
Poland
State/province [423] 0 0
Przemysl
Country [424] 0 0
Poland
State/province [424] 0 0
Plock
Country [425] 0 0
Poland
State/province [425] 0 0
Radzionków
Country [426] 0 0
Poland
State/province [426] 0 0
Rzeszów
Country [427] 0 0
Poland
State/province [427] 0 0
Skórzewo
Country [428] 0 0
Poland
State/province [428] 0 0
Szczecin
Country [429] 0 0
Poland
State/province [429] 0 0
Tarnów
Country [430] 0 0
Poland
State/province [430] 0 0
Torun
Country [431] 0 0
Poland
State/province [431] 0 0
Warszawa
Country [432] 0 0
Poland
State/province [432] 0 0
Wroclaw
Country [433] 0 0
Poland
State/province [433] 0 0
Zabrze
Country [434] 0 0
Poland
State/province [434] 0 0
Lódz
Country [435] 0 0
Romania
State/province [435] 0 0
Bacau
Country [436] 0 0
Romania
State/province [436] 0 0
Baia Mare
Country [437] 0 0
Romania
State/province [437] 0 0
Brasov
Country [438] 0 0
Romania
State/province [438] 0 0
Bucharest
Country [439] 0 0
Romania
State/province [439] 0 0
Bucuresti
Country [440] 0 0
Romania
State/province [440] 0 0
Craiova
Country [441] 0 0
Romania
State/province [441] 0 0
Iasi
Country [442] 0 0
Romania
State/province [442] 0 0
Ploiesti
Country [443] 0 0
Romania
State/province [443] 0 0
Satu Mare
Country [444] 0 0
Romania
State/province [444] 0 0
Targu Mures
Country [445] 0 0
Slovakia
State/province [445] 0 0
Bratislava
Country [446] 0 0
Slovakia
State/province [446] 0 0
Brezno
Country [447] 0 0
Slovakia
State/province [447] 0 0
Kosice
Country [448] 0 0
Slovakia
State/province [448] 0 0
Košice
Country [449] 0 0
Slovakia
State/province [449] 0 0
Lucenec
Country [450] 0 0
Slovakia
State/province [450] 0 0
Malacky
Country [451] 0 0
Slovakia
State/province [451] 0 0
Namestovo
Country [452] 0 0
Slovakia
State/province [452] 0 0
Prievidza
Country [453] 0 0
Slovakia
State/province [453] 0 0
Rimavska Sobota
Country [454] 0 0
Slovakia
State/province [454] 0 0
Roznava
Country [455] 0 0
Slovakia
State/province [455] 0 0
Sabinov
Country [456] 0 0
Slovakia
State/province [456] 0 0
Svidník
Country [457] 0 0
Slovakia
State/province [457] 0 0
Lubochna
Country [458] 0 0
South Africa
State/province [458] 0 0
Benoni
Country [459] 0 0
South Africa
State/province [459] 0 0
Brackenfell
Country [460] 0 0
South Africa
State/province [460] 0 0
Cape Town
Country [461] 0 0
South Africa
State/province [461] 0 0
Centurion
Country [462] 0 0
South Africa
State/province [462] 0 0
Diepkloof, Soweto
Country [463] 0 0
South Africa
State/province [463] 0 0
Durban
Country [464] 0 0
South Africa
State/province [464] 0 0
East London
Country [465] 0 0
South Africa
State/province [465] 0 0
George
Country [466] 0 0
South Africa
State/province [466] 0 0
Lenasia
Country [467] 0 0
South Africa
State/province [467] 0 0
Midrand
Country [468] 0 0
South Africa
State/province [468] 0 0
Paarl
Country [469] 0 0
South Africa
State/province [469] 0 0
Parow
Country [470] 0 0
South Africa
State/province [470] 0 0
Pretoria
Country [471] 0 0
South Africa
State/province [471] 0 0
Somerset West
Country [472] 0 0
South Africa
State/province [472] 0 0
Umkomaas
Country [473] 0 0
South Africa
State/province [473] 0 0
Worcester
Country [474] 0 0
Spain
State/province [474] 0 0
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Vinh Yen

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/NCT06677060