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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06742723




Registration number
NCT06742723
Ethics application status
Date submitted
16/12/2024
Date registered
19/12/2024

Titles & IDs
Public title
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Scientific title
A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure
Secondary ID [1] 0 0
2023-506460-14-00
Secondary ID [2] 0 0
D6972C00002
Universal Trial Number (UTN)
Trial acronym
BaxDuo-Pacific
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease and Hypertension 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Hypertension

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

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

Placebo comparator: Placebo/dapagliflozin - Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily.


Treatment: Drugs: Baxdrostat/dapagliflozin
baxdrostat tablet

dapagliflozin tablet

Treatment: Drugs: Placebo/dapagliflozin
dapagliflozin tablet

placebo tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of = 50% sustained decline in eGFR (estimated glomerular filtration rate)
Timepoint [1] 0 0
Up to 41 months
Primary outcome [2] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of kidney failure
Timepoint [2] 0 0
Up to 41 months
Primary outcome [3] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of CV (cardiovascular) death.
Timepoint [3] 0 0
Up to 41 months
Secondary outcome [1] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin at reducing UACR (urine albumin-creatinine ratio).
Timepoint [1] 0 0
Baseline- 16 weeks
Secondary outcome [2] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin at reducing SBP (systolic blood pressure).
Timepoint [2] 0 0
Baseline- 16 weeks
Secondary outcome [3] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MACE (Major Adverse Cardiac Events).
Timepoint [3] 0 0
Up to 41 months
Secondary outcome [4] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death.
Timepoint [4] 0 0
Up to 41 months
Secondary outcome [5] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of all-cause death.
Timepoint [5] 0 0
Up to 41 months

Eligibility
Key inclusion criteria
1. Participants of any sex and gender must be = 18 years of age at the time of signing the informed consent.
2. Participants with:

1. eGFR = 30 and < 60 mL/min/1.73 m2 (local or central laboratory values) AND UACR = 30 mg/g (3.39 mg/mmol) and < 500 mg/g (56.5 mg/mmol) (central laboratory values only), or
2. eGFR = 30 and = 75 mL/min/1.73 m2 (local or central laboratory values) AND UACR = 500 mg/g (56.5 mg/mmol) and = 5000 mg/g (565 mg/mmol) or UPCR = 700 mg/g (79 mg/mmol) and = 7000 mg/g (790 mg/mmol) (local or central laboratory values).
3. [obsolete]
4. Participants with history of HTN and a SBP = 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and = 120 mmHg at the Randomisation Visit.
5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
6. Participants with:

1. Serum or plasma potassium = 3.0 and = 4.8 mmol/L if eGFR = 45 mL/min/1.73 m2 (local or central laboratory values).
2. Serum or plasma potassium = 3.0 and = 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2 (local or central laboratory values).
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening.
2. Known hyperkalaemia, defined as potassium of = 5.5 mmol/L within 3 months prior to screening.
3. Serum sodium < 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).

4. T1DM:

1. For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.
2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.

5 Uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).

6 New York Heart Association functional HF class IV at screening.

7 Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.

8 Documented history of adrenal insufficiency.

9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.

10 Any acute kidney injury within 3 months prior to the Screening Visit.

11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).

12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/04/2030
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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Research Site - Adelaide
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Research Site - Gosford
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Research Site - st Leonards
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Research Site - Wollongong
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5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
6000 - Perth
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4215 - Southport
Recruitment postcode(s) [5] 0 0
2065 - st Leonards
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
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Heidelberg
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Germany
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Germany
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Karlsburg
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Germany
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Karlsruhe
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Germany
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Mainz
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Germany
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Obertshausen
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Germany
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Offenbach am Main
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Germany
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Potsdam
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Germany
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Reinfeld (Holstein)
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Germany
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Rostock
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Germany
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Rotenburg (Wümme)
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Germany
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Stuttgart
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Germany
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Ulm
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Germany
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Zwenkau
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Greece
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Hungary
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Dunaujvaros
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Hungary
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Encs
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Hungary
State/province [213] 0 0
Gyor
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Hungary
State/province [214] 0 0
Kaposvár
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Hungary
State/province [215] 0 0
Nyiregyhaza
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Hungary
State/province [216] 0 0
Nyíregyháza
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Hungary
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Szeged
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Hungary
State/province [218] 0 0
Szolnok
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Hungary
State/province [219] 0 0
Székesfehérvár
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Hungary
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Zalaegerszeg
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India
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Bangalore
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India
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Hyderabad
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India
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Kolkata
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India
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Madurai
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India
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Mumbai
Country [226] 0 0
India
State/province [226] 0 0
New Delhi
Country [227] 0 0
India
State/province [227] 0 0
Pune
Country [228] 0 0
India
State/province [228] 0 0
Vijayawada
Country [229] 0 0
Israel
State/province [229] 0 0
Afula
Country [230] 0 0
Israel
State/province [230] 0 0
Ashdod
Country [231] 0 0
Israel
State/province [231] 0 0
Be'er Ya'akov
Country [232] 0 0
Israel
State/province [232] 0 0
Haifa
Country [233] 0 0
Israel
State/province [233] 0 0
Jerusalem
Country [234] 0 0
Israel
State/province [234] 0 0
Kfar-Saba
Country [235] 0 0
Israel
State/province [235] 0 0
Nahariya
Country [236] 0 0
Israel
State/province [236] 0 0
Petah Tikva
Country [237] 0 0
Israel
State/province [237] 0 0
Rehovot
Country [238] 0 0
Israel
State/province [238] 0 0
Tel Aviv
Country [239] 0 0
Israel
State/province [239] 0 0
Tiberias
Country [240] 0 0
Italy
State/province [240] 0 0
Bassano del Grappa
Country [241] 0 0
Italy
State/province [241] 0 0
Bologna
Country [242] 0 0
Italy
State/province [242] 0 0
Desio
Country [243] 0 0
Italy
State/province [243] 0 0
Foggia
Country [244] 0 0
Italy
State/province [244] 0 0
Genoa
Country [245] 0 0
Italy
State/province [245] 0 0
Modena
Country [246] 0 0
Italy
State/province [246] 0 0
Napoli
Country [247] 0 0
Italy
State/province [247] 0 0
Novara
Country [248] 0 0
Italy
State/province [248] 0 0
Padova
Country [249] 0 0
Italy
State/province [249] 0 0
Pavia
Country [250] 0 0
Italy
State/province [250] 0 0
Pisa
Country [251] 0 0
Italy
State/province [251] 0 0
Pordenone
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Italy
State/province [252] 0 0
Roma
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Italy
State/province [253] 0 0
Rozzano
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Italy
State/province [254] 0 0
Torino
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Italy
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Tradate
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Japan
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Aira-City
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Japan
State/province [257] 0 0
Amagasaki-shi
Country [258] 0 0
Japan
State/province [258] 0 0
Beppu-shi
Country [259] 0 0
Japan
State/province [259] 0 0
Chigasaki-shi
Country [260] 0 0
Japan
State/province [260] 0 0
Hakodate-shi
Country [261] 0 0
Japan
State/province [261] 0 0
Hamamatsu-shi
Country [262] 0 0
Japan
State/province [262] 0 0
Higashihiroshima-shi
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Japan
State/province [263] 0 0
Iizuka-shi
Country [264] 0 0
Japan
State/province [264] 0 0
Inashiki-gun
Country [265] 0 0
Japan
State/province [265] 0 0
Itabashi-ku
Country [266] 0 0
Japan
State/province [266] 0 0
Iwata-shi
Country [267] 0 0
Japan
State/province [267] 0 0
Kagoshima
Country [268] 0 0
Japan
State/province [268] 0 0
Kamakura-shi
Country [269] 0 0
Japan
State/province [269] 0 0
Kanazawa-shi
Country [270] 0 0
Japan
State/province [270] 0 0
Kashiwara-shi
Country [271] 0 0
Japan
State/province [271] 0 0
Kasugai-shi
Country [272] 0 0
Japan
State/province [272] 0 0
Kita-ku
Country [273] 0 0
Japan
State/province [273] 0 0
Kitakyushu-shi
Country [274] 0 0
Japan
State/province [274] 0 0
Kitakyushu
Country [275] 0 0
Japan
State/province [275] 0 0
Kobe-shi
Country [276] 0 0
Japan
State/province [276] 0 0
Kumagaya-shi
Country [277] 0 0
Japan
State/province [277] 0 0
Kuse-gun
Country [278] 0 0
Japan
State/province [278] 0 0
Kuwana-shi
Country [279] 0 0
Japan
State/province [279] 0 0
Matsusaka-shi
Country [280] 0 0
Japan
State/province [280] 0 0
Matsuyama-city
Country [281] 0 0
Japan
State/province [281] 0 0
Meguro-ku
Country [282] 0 0
Japan
State/province [282] 0 0
Minato-ku
Country [283] 0 0
Japan
State/province [283] 0 0
Minokamo shi
Country [284] 0 0
Japan
State/province [284] 0 0
Miyakonojo-shi
Country [285] 0 0
Japan
State/province [285] 0 0
Morioka-shi
Country [286] 0 0
Japan
State/province [286] 0 0
Nagaoka-shi
Country [287] 0 0
Japan
State/province [287] 0 0
Naka
Country [288] 0 0
Japan
State/province [288] 0 0
Narita-shi
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Japan
State/province [289] 0 0
Obihiro-shi
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Japan
State/province [290] 0 0
Oita-shi
Country [291] 0 0
Japan
State/province [291] 0 0
Ome
Country [292] 0 0
Japan
State/province [292] 0 0
Omihachiman-shi
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Japan
State/province [293] 0 0
Osaka-shi
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Japan
State/province [294] 0 0
Osaka
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Japan
State/province [295] 0 0
Saga-shi
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Japan
State/province [296] 0 0
Sapporo-shi
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Japan
State/province [297] 0 0
Sendai-shi
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Japan
State/province [298] 0 0
Shibuya-ku
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Japan
State/province [299] 0 0
Toyoake-shi
Country [300] 0 0
Japan
State/province [300] 0 0
Toyohashi-shi
Country [301] 0 0
Japan
State/province [301] 0 0
Tsu-shi
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Japan
State/province [302] 0 0
Yaizu-shi
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Japan
State/province [303] 0 0
Yokohama-shi
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Korea, Republic of
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Ansan-si
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Korea, Republic of
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Anyang-si
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Korea, Republic of
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Busan
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Korea, Republic of
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Cheonan-si
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Korea, Republic of
State/province [308] 0 0
Goyang-si
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Korea, Republic of
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Gwangju
Country [310] 0 0
Korea, Republic of
State/province [310] 0 0
Seoul
Country [311] 0 0
Korea, Republic of
State/province [311] 0 0
Wonju-si
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Korea, Republic of
State/province [312] 0 0
Yangsan-si
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Ampang
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Malaysia
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Cheras
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Malaysia
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Ipoh
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Malaysia
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Kajang
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Malaysia
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Kota Bharu
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Malaysia
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Kuala Lumpur
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Malaysia
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Seremban
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Malaysia
State/province [320] 0 0
Seri Manjung
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Mexico
State/province [321] 0 0
Chihuahua
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Mexico
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Cuauhtemoc
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Mexico
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Cuauhtémoc
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Mexico
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D.F
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Mexico
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Guadalajara
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Mexico
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Mazatlán
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Mexico
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Merida
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Mexico
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San Luis Potosí
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Mexico
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Netherlands
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Dordrecht
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Groningen
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Netherlands
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Hilversum
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Netherlands
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Leiden
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Netherlands
State/province [336] 0 0
Maastricht
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Netherlands
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Nieuwegein
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Netherlands
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Zwolle
Country [339] 0 0
Peru
State/province [339] 0 0
Arequipa
Country [340] 0 0
Peru
State/province [340] 0 0
Bellavista
Country [341] 0 0
Peru
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Chorrillos
Country [342] 0 0
Peru
State/province [342] 0 0
Lima
Country [343] 0 0
Peru
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LIma
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Peru
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Piura
Country [345] 0 0
Philippines
State/province [345] 0 0
Cebu City
Country [346] 0 0
Philippines
State/province [346] 0 0
Davao City
Country [347] 0 0
Philippines
State/province [347] 0 0
Iloilo City
Country [348] 0 0
Philippines
State/province [348] 0 0
Laguna
Country [349] 0 0
Philippines
State/province [349] 0 0
Manila
Country [350] 0 0
Philippines
State/province [350] 0 0
Quezon City
Country [351] 0 0
Philippines
State/province [351] 0 0
San Fernando
Country [352] 0 0
Poland
State/province [352] 0 0
Bialystok
Country [353] 0 0
Poland
State/province [353] 0 0
Gdynia
Country [354] 0 0
Poland
State/province [354] 0 0
Grodzisk Mazowiecki
Country [355] 0 0
Poland
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Jaslo
Country [356] 0 0
Poland
State/province [356] 0 0
Katowice
Country [357] 0 0
Poland
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Krakow
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Poland
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Kraków
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Poland
State/province [359] 0 0
Lublin
Country [360] 0 0
Poland
State/province [360] 0 0
Piaseczno
Country [361] 0 0
Poland
State/province [361] 0 0
Poznan
Country [362] 0 0
Poland
State/province [362] 0 0
Radom
Country [363] 0 0
Poland
State/province [363] 0 0
Rzeszów
Country [364] 0 0
Poland
State/province [364] 0 0
Szczecin
Country [365] 0 0
Poland
State/province [365] 0 0
Tczew
Country [366] 0 0
Poland
State/province [366] 0 0
Warszawa
Country [367] 0 0
Poland
State/province [367] 0 0
Wroclaw
Country [368] 0 0
Poland
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Lódz
Country [369] 0 0
Poland
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Swiecie
Country [370] 0 0
Poland
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Zywiec
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Romania
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Brasov
Country [372] 0 0
Romania
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Bucharest
Country [373] 0 0
Romania
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Bucuresti
Country [374] 0 0
Romania
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Cluj Napoca
Country [375] 0 0
Romania
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Craiova
Country [376] 0 0
Romania
State/province [376] 0 0
Oradea
Country [377] 0 0
Romania
State/province [377] 0 0
Suceava
Country [378] 0 0
Romania
State/province [378] 0 0
Timisoara
Country [379] 0 0
Saudi Arabia
State/province [379] 0 0
Al-Ahsa
Country [380] 0 0
Saudi Arabia
State/province [380] 0 0
Dammam
Country [381] 0 0
Saudi Arabia
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Riyadh
Country [382] 0 0
Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Nis
Country [385] 0 0
Serbia
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Novi Sad
Country [386] 0 0
Singapore
State/province [386] 0 0
Singapore
Country [387] 0 0
Slovakia
State/province [387] 0 0
Koshice
Country [388] 0 0
Slovakia
State/province [388] 0 0
Královský Chlmec
Country [389] 0 0
Slovakia
State/province [389] 0 0
Myjava
Country [390] 0 0
Slovakia
State/province [390] 0 0
Nitra
Country [391] 0 0
Slovakia
State/province [391] 0 0
Presov
Country [392] 0 0
Slovakia
State/province [392] 0 0
Prešov
Country [393] 0 0
Slovakia
State/province [393] 0 0
Puchov
Country [394] 0 0
Slovakia
State/province [394] 0 0
Zilina
Country [395] 0 0
South Africa
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Benoni
Country [396] 0 0
South Africa
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Bloemfontein
Country [397] 0 0
South Africa
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Cape Town
Country [398] 0 0
South Africa
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Durban
Country [399] 0 0
South Africa
State/province [399] 0 0
Lenasia
Country [400] 0 0
South Africa
State/province [400] 0 0
Midrand
Country [401] 0 0
South Africa
State/province [401] 0 0
Newton
Country [402] 0 0
South Africa
State/province [402] 0 0
Parow
Country [403] 0 0
Spain
State/province [403] 0 0
A Coruña
Country [404] 0 0
Spain
State/province [404] 0 0
Almeria
Country [405] 0 0
Spain
State/province [405] 0 0
Badalona
Country [406] 0 0
Spain
State/province [406] 0 0
L'Hospitalet de Llobregat
Country [407] 0 0
Spain
State/province [407] 0 0
Majadahonda
Country [408] 0 0
Spain
State/province [408] 0 0
Málaga
Country [409] 0 0
Spain
State/province [409] 0 0
Palma deMallorca
Country [410] 0 0
Spain
State/province [410] 0 0
Pamplona
Country [411] 0 0
Spain
State/province [411] 0 0
Sevilla
Country [412] 0 0
Spain
State/province [412] 0 0
Valencia
Country [413] 0 0
Sweden
State/province [413] 0 0
Danderyd
Country [414] 0 0
Sweden
State/province [414] 0 0
Huddinge
Country [415] 0 0
Sweden
State/province [415] 0 0
Karlstad
Country [416] 0 0
Sweden
State/province [416] 0 0
Linköping
Country [417] 0 0
Sweden
State/province [417] 0 0
Uppsala
Country [418] 0 0
Sweden
State/province [418] 0 0
Växjö
Country [419] 0 0
Taiwan
State/province [419] 0 0
New Taipei
Country [420] 0 0
Taiwan
State/province [420] 0 0
Taichung
Country [421] 0 0
Taiwan
State/province [421] 0 0
Taipei City
Country [422] 0 0
Taiwan
State/province [422] 0 0
Taipei
Country [423] 0 0
Taiwan
State/province [423] 0 0
Taoyuan
Country [424] 0 0
Taiwan
State/province [424] 0 0
Yung Kang City
Country [425] 0 0
Thailand
State/province [425] 0 0
Bangkok
Country [426] 0 0
Thailand
State/province [426] 0 0
Banphaeo
Country [427] 0 0
Thailand
State/province [427] 0 0
Hat Yai
Country [428] 0 0
Thailand
State/province [428] 0 0
Khon Kaen
Country [429] 0 0
Thailand
State/province [429] 0 0
Mueang
Country [430] 0 0
Thailand
State/province [430] 0 0
Phutthamonthon
Country [431] 0 0
Thailand
State/province [431] 0 0
Ubonratchathani
Country [432] 0 0
Turkey
State/province [432] 0 0
Adana
Country [433] 0 0
Turkey
State/province [433] 0 0
Adapazari
Country [434] 0 0
Turkey
State/province [434] 0 0
Altindag
Country [435] 0 0
Turkey
State/province [435] 0 0
Ankara
Country [436] 0 0
Turkey
State/province [436] 0 0
Antalya
Country [437] 0 0
Turkey
State/province [437] 0 0
Haliliye
Country [438] 0 0
Turkey
State/province [438] 0 0
Kahramanmaras
Country [439] 0 0
Turkey
State/province [439] 0 0
Kayseri
Country [440] 0 0
Turkey
State/province [440] 0 0
Kocaeli
Country [441] 0 0
Turkey
State/province [441] 0 0
Sahinbey
Country [442] 0 0
Ukraine
State/province [442] 0 0
Chernivts?
Country [443] 0 0
Ukraine
State/province [443] 0 0
Ivano-Frankivsk
Country [444] 0 0
Ukraine
State/province [444] 0 0
Kyiv
Country [445] 0 0
Ukraine
State/province [445] 0 0
Ternopil
Country [446] 0 0
Ukraine
State/province [446] 0 0
Uzhhorod
Country [447] 0 0
Ukraine
State/province [447] 0 0
Vinnytsia
Country [448] 0 0
Ukraine
State/province [448] 0 0
Vinnytsya
Country [449] 0 0
Ukraine
State/province [449] 0 0
Zhytomyr
Country [450] 0 0
United Kingdom
State/province [450] 0 0
Bradford
Country [451] 0 0
United Kingdom
State/province [451] 0 0
Bristol
Country [452] 0 0
United Kingdom
State/province [452] 0 0
Canterbury
Country [453] 0 0
United Kingdom
State/province [453] 0 0
Cardiff
Country [454] 0 0
United Kingdom
State/province [454] 0 0
Dundee
Country [455] 0 0
United Kingdom
State/province [455] 0 0
Glasgow
Country [456] 0 0
United Kingdom
State/province [456] 0 0
Hownslow
Country [457] 0 0
United Kingdom
State/province [457] 0 0
London
Country [458] 0 0
United Kingdom
State/province [458] 0 0
Salford
Country [459] 0 0
United Kingdom
State/province [459] 0 0
Southampton
Country [460] 0 0
United Kingdom
State/province [460] 0 0
Swansea
Country [461] 0 0
Vietnam
State/province [461] 0 0
Da Nang
Country [462] 0 0
Vietnam
State/province [462] 0 0
Hai Phong
Country [463] 0 0
Vietnam
State/province [463] 0 0
Hanoi
Country [464] 0 0
Vietnam
State/province [464] 0 0
Hcmc
Country [465] 0 0
Vietnam
State/province [465] 0 0
Ho Chi Minh City
Country [466] 0 0
Vietnam
State/province [466] 0 0
Ho Chi Minh

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/NCT06742723