A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
NCT ID: NCT06034743
Last Updated: 2025-11-10
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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COMPLETED
PHASE3
796 participants
INTERVENTIONAL
2023-11-22
2025-10-10
Brief Summary
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Detailed Description
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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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2 mg baxdrostat
2 mg baxdrostat administered orally, once daily (QD).
Baxdrostat
Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths:
* 1 mg per tablet for 1 mg baxdrostat Arm;
* 2 mg per tablet for 2 mg baxdrostat Arm.
1 mg baxdrostat
1 mg baxdrostat administered orally, once daily (QD).
Baxdrostat
Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths:
* 1 mg per tablet for 1 mg baxdrostat Arm;
* 2 mg per tablet for 2 mg baxdrostat Arm.
Placebo
Placebo administered orally, once daily (QD).
Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Interventions
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Baxdrostat
Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths:
* 1 mg per tablet for 1 mg baxdrostat Arm;
* 2 mg per tablet for 2 mg baxdrostat Arm.
Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and \< 170 mmHg at Screening
* Fulfil at least 1 of the following 2 criteria:
1. uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
2. rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
* Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening
* Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening
* Randomisation Criterion:
* Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at the Baseline Visit
Exclusion Criteria
* Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg
* Serum sodium level \< 135 mmol/L at Screening
* Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation
* New York Heart Association functional heart failure class IV at Screening
* Persistent atrial fibrillation
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Saraland, Alabama, United States
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Scottsdale, Arizona, United States
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Sun City West, Arizona, United States
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Surprise, Arizona, United States
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Little Rock, Arkansas, United States
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Fresno, California, United States
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Lincoln, California, United States
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Orange, California, United States
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Rancho Cucamonga, California, United States
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Stanford, California, United States
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New Haven, Connecticut, United States
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Clearwater, Florida, United States
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Jacksonville, Florida, United States
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Port Orange, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Springfield, Illinois, United States
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Munster, Indiana, United States
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Lexington, Kentucky, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Olive Branch, Mississippi, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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Rosedale, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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New Bern, North Carolina, United States
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Toledo, Ohio, United States
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Grants Pass, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Memphis, Tennessee, United States
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Brownsville, Texas, United States
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Corpus Christi, Texas, United States
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Houston, Texas, United States
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Sugar Land, Texas, United States
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Manassas, Virginia, United States
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Suffolk, Virginia, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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CABA, , Argentina
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CABA, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Mar del Plata, , Argentina
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Mendoza, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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San Nicolás, , Argentina
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San Vicente, , Argentina
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Clayton, , Australia
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Darlinghurst, , Australia
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Epping, , Australia
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Geelong, , Australia
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Liverpool, , Australia
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New Lambton Heights, , Australia
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Perth, , Australia
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Wollongong, , Australia
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Woolloongabba, , Australia
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Braunau am Inn, , Austria
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Sankt Pölten, , Austria
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Vienna, , Austria
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Ghent, , Belgium
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Liège, , Belgium
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Mons, , Belgium
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Edmonton, Alberta, Canada
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North Vancouver, British Columbia, Canada
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Cambridge, Ontario, Canada
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Markham, Ontario, Canada
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Newmarket, Ontario, Canada
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Ottawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Saint-Jean-sur-Richelieu, Quebec, Canada
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Benešov, , Czechia
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Brandýs nad Labem, , Czechia
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Broumov, , Czechia
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Louny, , Czechia
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Ostrava, , Czechia
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Příbram, , Czechia
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Uherské Hradiště, , Czechia
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Aarhus, , Denmark
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Herning, , Denmark
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Holbæk, , Denmark
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Bobigny, , France
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Bordeaux, , France
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Paris, , France
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Paris, , France
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Saint-Priest-en-Jarez, , France
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Toulon, , France
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Toulouse, , France
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Tours, , France
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Bad Homburg, , Germany
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Bad Oeynhausen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Dortmund, , Germany
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Düsseldorf, , Germany
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Elsterwerda, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Hanover, , Germany
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Hanover, , Germany
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Homburg, , Germany
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Kaiserslautern, , Germany
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Leipzig, , Germany
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Mannheim, , Germany
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Wermsdorf, , Germany
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Kalocsa, , Hungary
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Kaposvár, , Hungary
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Nyíregyháza, , Hungary
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Pécs, , Hungary
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Delhi, , India
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Delhi, , India
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Guntur, , India
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Kanpur, , India
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Kolkata, , India
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Kolkata, , India
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Mysuru, , India
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Mysuru, , India
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New Delhi, , India
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New Delhi, , India
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Surat, , India
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Ashdod, , Israel
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Haifa, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Rehovot, , Israel
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Acquaviva delle Fonti, , Italy
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Bologna, , Italy
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Brescia, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Pisa, , Italy
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Roma, , Italy
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Torino, , Italy
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Udine, , Italy
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Adachi-ku, , Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Kanazawa, , Japan
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Koga-shi, , Japan
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Kyoto, , Japan
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Nagasaki, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Sapporo, , Japan
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Tsuchiura-shi, , Japan
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Yufu-shi, , Japan
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Kajang, , Malaysia
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Kota Bharu, , Malaysia
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Kuching, , Malaysia
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Malacca, , Malaysia
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Muar town, , Malaysia
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Sarawak Miri, , Malaysia
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Seri Manjung, , Malaysia
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Hoogeveen, , Netherlands
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Nijmegen, , Netherlands
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Utrecht, , Netherlands
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Chrzanów, , Poland
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Gdansk, , Poland
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Gdynia, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Brezno, , Slovakia
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Košice, , Slovakia
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Moldava nad Bodvou, , Slovakia
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Prešov, , Slovakia
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Rimavská Sobota, , Slovakia
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Svidník, , Slovakia
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Cape Town, , South Africa
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Centurion, , South Africa
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Claremont, , South Africa
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Durban, , South Africa
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Kwadwesi, , South Africa
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Somerset West, , South Africa
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Worcester, , South Africa
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Bucheon-si, , South Korea
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Busan, , South Korea
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Daejeon, , South Korea
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Incheon, , 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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Seoul, , 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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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Ferrol, , Spain
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Granada, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Seville, , Spain
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Terrassa (Barcelona), , Spain
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Gothenburg, , Sweden
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Uppsala, , Sweden
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , 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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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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Chiang Mai, , Thailand
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Hat Yai, , Thailand
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Khon Kaen, , Thailand
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Pathum Thani, , Thailand
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Dinar, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kütahya, , Turkey (Türkiye)
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Odunpazari, , Turkey (Türkiye)
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Bollington, , United Kingdom
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Bristol, , United Kingdom
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Chesterfield, , United Kingdom
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Dundee, , United Kingdom
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Glasgow, , United Kingdom
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Harrow, , 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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Prescot, , United Kingdom
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Weston-super-Mare, , United Kingdom
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Yate, , United Kingdom
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Da Nang, , 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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Hochiminh City, , Vietnam
Countries
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References
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Flack JM, Azizi M, Brown JM, Dwyer JP, Fronczek J, Jones ESW, Olsson DS, Perl S, Shibata H, Wang JG, Wilderang U, Wittes J, Williams B; BaxHTN Investigators. Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension. N Engl J Med. 2025 Oct 9;393(14):1363-1374. doi: 10.1056/NEJMoa2507109. Epub 2025 Aug 30.
Other Identifiers
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2023-505499-32-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D6970C00002
Identifier Type: -
Identifier Source: org_study_id