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
NCT ID: NCT06742723
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
5000 participants
INTERVENTIONAL
2025-03-03
2029-12-18
Brief Summary
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Detailed Description
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This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin.
Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months.
The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor.
In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Baxdrostat/dapagliflozin
baxdrostat tablet
dapagliflozin tablet
Placebo/dapagliflozin
Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily.
Placebo/dapagliflozin
dapagliflozin tablet
placebo tablet
Interventions
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Baxdrostat/dapagliflozin
baxdrostat tablet
dapagliflozin tablet
Placebo/dapagliflozin
dapagliflozin tablet
placebo tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants with (a) or (b):
1. eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND:
* UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmol) (central laboratory value only), or
* UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
* UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only).
(b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND:
* UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
* UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only)
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
Exclusion Criteria
2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at 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\. Participants with T1DM will be excluded, except:
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).
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Fairhope, Alabama, United States
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Surprise, Arizona, United States
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Tucson, Arizona, United States
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Beverly Hills, California, United States
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Canoga Park, California, United States
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Concord, California, United States
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Fremont, California, United States
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Fullerton, California, United States
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Inglewood, California, United States
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Los Alamitos, California, United States
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San Diego, California, United States
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Stanford, California, United States
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Tarzana, California, United States
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Arvada, Colorado, United States
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Denver, Colorado, United States
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New Britain, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Boynton Beach, Florida, United States
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Edgewater, Florida, United States
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Fort Lauderdale, Florida, United States
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Hollywood, Florida, United States
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Jacksonville Beach, Florida, United States
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Lake City, Florida, United States
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Lakeland, Florida, United States
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Melbourne, Florida, United States
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Miami Lakes, Florida, United States
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Ocoee, Florida, United States
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Port Charlotte, Florida, United States
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Port Orange, Florida, United States
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Riverview, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Austell, Georgia, United States
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Brunswick, Georgia, United States
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Conyers, Georgia, United States
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Decatur, Georgia, United States
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Lawrenceville, Georgia, United States
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Riverdale, Georgia, United States
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Honolulu, Hawaii, United States
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Champaign, Illinois, United States
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Maywood, Illinois, United States
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Rockford, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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West Des Moines, Iowa, United States
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Hutchinson, Kansas, United States
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Kansas City, Kansas, United States
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Wichita, Kansas, United States
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Kenner, Louisiana, United States
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Metairie, Louisiana, United States
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West Monroe, Louisiana, United States
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Bethesda, Maryland, United States
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New Bedford, Massachusetts, United States
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Saint Joseph, Michigan, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Norfolk, Nebraska, United States
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Las Vegas, Nevada, United States
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Eatontown, New Jersey, United States
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Albany, New York, United States
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Buffalo, New York, United States
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New York, New York, United States
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Greenville, North Carolina, United States
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Hickory, North Carolina, United States
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Jacksonville, North Carolina, United States
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Kinston, North Carolina, United States
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Morehead City, North Carolina, United States
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New Bern, North Carolina, United States
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Raleigh, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Sanford, North Carolina, United States
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Statesville, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Bridgeville, Pennsylvania, United States
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Chester, Pennsylvania, United States
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Exton, Pennsylvania, United States
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Kittanning, Pennsylvania, United States
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East Providence, Rhode Island, United States
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East Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Chattanooga, Tennessee, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Arlington, Virginia, United States
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Manassas, Virginia, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Woodbridge, Virginia, United States
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Seattle, Washington, United States
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CABA, , Argentina
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Ciudad Autonoma de Bs As, , Argentina
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La Plata, , Argentina
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Rosario, , Argentina
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Santa Fe, , Argentina
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Temperley, , Argentina
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Adelaide, , Australia
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Darlinghurst, , Australia
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Elizabeth Vale, , Australia
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Gosford, , Australia
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Perth, , Australia
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Southport, , Australia
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St Leonards, , Australia
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Wollongong, , Australia
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Aalst, , Belgium
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Brussels, , Belgium
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Genk, , Belgium
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Hasselt, , Belgium
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Ieper, , Belgium
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Jette, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Mechelen, , Belgium
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Namur, , Belgium
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Roeselare, , Belgium
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Barretos, , Brazil
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Byala, , Bulgaria
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Edmonton, Alberta, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Saint John, New Brunswick, Canada
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London, Ontario, Canada
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Oshawa, Ontario, Canada
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Sarnia, Ontario, Canada
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Waterloo, Ontario, Canada
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Québec, Quebec, Canada
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Araucania, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Valdivia, , Chile
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Victoria, , Chile
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Viña del Mar, , Chile
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Baotou, , China
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Hefei, , China
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Hengyang, , China
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Huaian, , China
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Jiaxing, , China
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Jinan, , China
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Jining, , China
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Lanzhou, , China
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Nanchang, , China
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Nanning, , China
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Ningbo, , China
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Panjin, , China
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Pingxiang, , China
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Shanghai, , China
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Shantou, , China
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Shenyang, , China
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Shenzhen, , China
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Suzhou, , China
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Tianjin, , China
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Wuhan, , China
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Wuhan, , China
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Wuxi, , China
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Xi'an, , China
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Xianyang, , China
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Yantai, , China
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Yinchuan, , China
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Zhengzhou, , China
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Zhongshan, , China
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Zhuzhou, , China
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Zigong, , China
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Barranquilla, , Colombia
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Cali, , Colombia
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Medellín, , Colombia
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Medellín, , Colombia
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Montería, , Colombia
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Pasto, , Colombia
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Brandýs nad Labem, , Czechia
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Brandýs nad Labem, , Czechia
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Frýdek-Místek, , Czechia
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Jilemnice, , Czechia
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Krnov, , Czechia
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Mladá Boleslav, , Czechia
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Náchod, , Czechia
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Olomouc, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Slaný, , Czechia
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Aalborg, , Denmark
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Aarhus, , Denmark
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Copenhagen E, , Denmark
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Herlev, , Denmark
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Herning, , Denmark
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Holbæk, , Denmark
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Kolding, , Denmark
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Alexandria, , Egypt
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Cairo, , Egypt
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Cairo, , Egypt
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Cairo, , Egypt
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Dakahlia, , Egypt
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Dakahlia, , Egypt
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Amiens, , France
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Bordeaux, , France
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Boulogne-Billancourt, , France
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Brest, , France
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Clermont-Ferrand, , France
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Créteil, , France
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La Roche-sur-Yon, , France
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Le Mans, , France
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Limoges, , France
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Lyon, , France
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Marseille, , France
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Nantes, , France
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Nice, , France
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Nîmes, , France
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Paris, , France
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Paris, , France
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Pierre-Bénite, , France
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Poitiers, , France
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Quimper, , France
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Reims, , France
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Rouen, , France
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Saint-Priest-en-Jarez, , France
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Strasbourg, , France
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Tours, , France
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Vandœuvre-lès-Nancy, , France
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Bad Homburg, , Germany
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Bamberg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Brandenburg, , Germany
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Dresden, , Germany
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Essen, , Germany
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Friedrichsthal, , Germany
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Görlitz, , Germany
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Göttingen, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Herne, , Germany
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Karlsburg, , Germany
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Karlsruhe, , Germany
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Landshut, , Germany
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Mainz, , Germany
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Offenbach, , Germany
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Potsdam, , Germany
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Reinfeld (Holstein), , Germany
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Rostock, , Germany
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Stuttgart, , Germany
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Ulm, , Germany
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Wermsdorf, , Germany
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Zwenkau, , Germany
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Alexandroupoli, , Greece
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Heraklion, , Greece
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Ioannina, , Greece
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Budapest, , Hungary
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Encs, , Hungary
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Győr, , Hungary
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Szeged, , Hungary
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Szolnok, , Hungary
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Zalaegerszeg, , Hungary
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Bangalore, , India
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Pune, , India
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Afula, , Israel
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Ashdod, , Israel
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Be’er Ya‘aqov, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Nahariya, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Tiberias, , Israel
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Bassano del Grappa, , Italy
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Bologna, , Italy
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Desio, , Italy
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Kagoshima, , Japan
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Kanazawa, , Japan
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Kitakyushu, , Japan
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Kobe, , Japan
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Kuse-gun, , Japan
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Kyoto, , Japan
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Kyoto, , Japan
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Toyohashi, , Japan
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Tsu, , Japan
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Yaizu-shi, , Japan
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Yokohama, , Japan
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Yoshida-gun, , Japan
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Ampang, , Malaysia
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Cheras, , Malaysia
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Ipoh, , Malaysia
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Kajang, , Malaysia
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Kota Bharu, , Malaysia
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Kuala Lumpur, , Malaysia
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Seremban, , Malaysia
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Seri Manjung, , Malaysia
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Chihuahua City, , Mexico
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Cuauhtémoc, , Mexico
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Cuauhtémoc, , Mexico
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D.F, , Mexico
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Durango, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Mazatlán, , Mexico
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Mazatlán, , Mexico
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Mérida, , Mexico
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San Luis Potosí City, , Mexico
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Veracruz, , Mexico
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Zapopan, , Mexico
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Amersfoort, , Netherlands
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Amsterdam, , Netherlands
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Dordrecht, , Netherlands
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Groningen, , Netherlands
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Hilversum, , Netherlands
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Leiden, , Netherlands
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Maastricht, , Netherlands
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Nieuwegein, , Netherlands
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Zwolle, , Netherlands
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Arequipa, , Peru
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Bellavista, , Peru
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Chorrillos, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Piura, , Peru
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Cebu City, , Philippines
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Davao City, , Philippines
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Davao City, , Philippines
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Iloilo City, , Philippines
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Iloilo City, , Philippines
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Laguna, , Philippines
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Manadaluyong City, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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San Fernando City, , Philippines
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Bialystok, , Poland
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Gdynia, , Poland
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Gdynia, , Poland
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Gmina Świecie, , Poland
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Grodzisk Mazowiecki, , Poland
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Jasło, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Piaseczno, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Radom, , Poland
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Rzeszów, , Poland
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Szczecin, , Poland
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Szczecin, , Poland
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Szczecin, , Poland
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Tczew, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Żywiec, , Poland
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Brasov, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Craiova, , Romania
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Craiova, , Romania
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Oradea, , Romania
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Suceava, , Romania
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Timișoara, , Romania
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Al-Ahsa, , Saudi Arabia
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Dammam, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh/MENA, , Saudi Arabia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Kragujevac, , Serbia
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Kragujevac, , Serbia
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Niš, , Serbia
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Novi Sad, , Serbia
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Novi Sad, , Serbia
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Košice, , Slovakia
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Kráľovský Chlmec, , Slovakia
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Myjava, , Slovakia
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Nitra, , Slovakia
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Prešov, , Slovakia
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Prešov, , Slovakia
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Púchov, , Slovakia
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Trenčín, , Slovakia
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Trnava, , Slovakia
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Žilina, , Slovakia
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Bellville, , South Africa
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Benoni, , South Africa
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Bloemfontein, , South Africa
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Bloemfontein, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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Extension 8, Lenasia, , South Africa
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Lenasia, , South Africa
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Midrand, , South Africa
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Newton, , South Africa
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Parow, , South Africa
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Ansan-si, , South Korea
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Anyang-si, , South Korea
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Busan, , South Korea
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Cheonan-si, , South Korea
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Goyang-si, , South Korea
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Gwangju, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Wŏnju, , South Korea
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Yangsan, , South Korea
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A Coruña, , Spain
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Almería, , Spain
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Badalona, , Spain
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L'Hospitalet de Llobregat, , Spain
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Majadahonda, , Spain
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Málaga, , Spain
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Palma deMallorca, , Spain
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Pamplona, , Spain
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Seville, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Danderyd, , Sweden
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Huddinge, , Sweden
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Karlstad, , Sweden
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Linköping, , Sweden
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Uppsala, , Sweden
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Vaxjo, , Sweden
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Yung Kang City, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Banphaeo, , Thailand
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Hat Yai, , Thailand
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Khon Kaen, , Thailand
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Mueang, , Thailand
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Phutthamonthon, , Thailand
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Ubonratchathani, , Thailand
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Adana, , Turkey (Türkiye)
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Adapazarı, , Turkey (Türkiye)
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Altındağ, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Haliliye, , Turkey (Türkiye)
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Kahramanmaraş, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Şahinbey, , Turkey (Türkiye)
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Chernivtsі, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Ternopil, , Ukraine
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Ternopil, , Ukraine
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Uzhhorod, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
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Zhytomyr, , Ukraine
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Bradford, , United Kingdom
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Bristol, , United Kingdom
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Canterbury, , United Kingdom
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Cardiff, , United Kingdom
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Dundee, , United Kingdom
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Glasgow, , United Kingdom
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Hownslow, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Salford, , United Kingdom
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Southampton, , United Kingdom
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Swansea, , United Kingdom
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Da Nang, , Vietnam
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Haiphong, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
References
Explore related publications, articles, or registry entries linked to this study.
Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2025 Sep 6. doi: 10.1681/ASN.0000000849. Online ahead of print. No abstract available.
Other Identifiers
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2023-506460-14-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D6972C00002
Identifier Type: -
Identifier Source: org_study_id