A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

Last updated: September 30, 2025
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

High Blood Pressure (Hypertension - Pediatric)

Stress

Circulation Disorders

Treatment

Placebo

Baxdrostat

Clinical Study ID

NCT06168409
D6970C00009
2023-507640-36-00
  • Ages 18-130
  • All Genders

Study Summary

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be ≥ 18 years old, at the time of signing the informed consent.

  • Mean seated SBP on AOBPM of ≥ 140 mmHg and < 170 mmHg at Screening.

  • Have a stable regimen of ≥ 3 antihypertensive medications, from differenttherapeutic classes (at least one must be a diuretic), at maximum tolerated dose inthe judgement of the Investigator, for at least 4 weeks prior to screening. Betablockers used to treat other conditions (ie, migraine, HF, coronary artery disease)should not be counted as an antihypertensive medication for the purpose ofqualifying for this study.

  • Have eGFR ≥ 45 mL/min/1.73 m2 at Screening.

  • Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening, determined as percentral laboratory

  • Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.

Exclusion

Exclusion Criteria:

  • Mean seated SBP on AOBPM ≥ 170 mmHg.

  • Mean seated DBP on AOBPM ≥ 110 mmHg.

  • Serum sodium level < 135 mmol/L at Screening, as per central laboratory.

  • Participant has the following known secondary causes of hypertension: renal arterystenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreatedhypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.

  • New York Heart Association functional HF class IV.

  • Persistent atrial fibrillation.

Study Design

Total Participants: 218
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 01, 2024
Estimated Completion Date:
August 17, 2025

Study Description

This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg baxdrostat versus placebo, administered once a day (QD) orally, on the reduction of ambulatory SBP in participants with rHTN, defined as BP targets not being achieved in an individual despite the use of at least 3 antihypertensive agents of different classes (at maximum tolerated dose in the judgement of the Investigator), one of which is a diuretic.

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    CABA, C1425AGC
    Argentina

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    Capital Federal, C1060ABN
    Argentina

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    Cordoba, X5003DCP
    Argentina

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    Córdoba 3860259, X5003DCP
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    Lanus Este, B1824KAJ
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    Lanús Este 12663399, B1824KAJ
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    Rosario, S2000PBJ
    Argentina

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    Rosario 3838583, S2000PBJ
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    San Miguel de Tucuman, 4000
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    San Miguel de Tucumán 3836873, 4000
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    San Vicente, 5006
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    San Vicente 3428068, 5006
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    Clayton, 3168
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    Clayton 2171400, 3168
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    Perth, 6000
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    Perth 2063523, 6000
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    Gent, 9000
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    Ghent 2797656, 9000
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    Mons, 7000
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    Sofia, 1680
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    Sofia 727011, 1527
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    Edmonton, Alberta T6G 2C8
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    Edmonton 5946768, Alberta 5883102 T6G 2C8
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    North Vancouver, British Columbia V7M 2H4
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    North Vancouver 6090785, British Columbia 5909050 V7M 2H4
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    Cambridge, Ontario N1R 6V6
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    Toronto, Ontario M6G 1M2
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    Waterloo, Ontario N2T 0C1
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    Cambridge 5913695, Ontario 6093943 N1R 6V6
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    Toronto 6167865, Ontario 6093943 M6G 1M2
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    Waterloo 6176823, Ontario 6093943 N2T 0C1
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    Chicoutimi, Quebec G7H 7K9
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    Terrebonne, Quebec J6X 4P7
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    Chicoutimi 5921225, Quebec 6115047 G7H 7K9
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    Terrebonne 6163012, Quebec 6115047 J6X 4P7
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    Benesov, 256 01
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    Benešov 3079508, 256 01
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    Brandys nad Labem, 250 01
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    Brandýs nad Labem 3078838, 250 01
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    Broumov, 55001
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    Broumov 3078577, 55001
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    Louny, 440 01
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    Louny 3071507, 440 01
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    Bad Homburg, 61348
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    Bad Homburg 2953436, 61348
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    Bad Oeynhausen, 32545
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    Berlin, 12203
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    Berlin 2950159, 12203
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    Elsterwerda, 04910
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    Erfurt, 99089
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    Frankfurt, 60590
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    Frankfurt 2925536, 60590
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    Kaiserslautern, 67655
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    Kaiserslautern 2894003, 67655
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    Athens, 11527
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    Athens 264371, 11527
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    Attica, 11527
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    Thessaloniki, 54642
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    Thessaloniki 734077, 54642
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    Budapest, 1148
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    Budapest 3054643, 1115
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    Kalocsa, 6300
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    Kalocsa 3050719, 6300
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    Nyíregyháza, 4400
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    Nyíregyháza 716935, 4400
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    Pécs 3046526, 7635
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    Szeged, 6724
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    Kota Bharu, 15586
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    Kota Bharu 1736376, 15586
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    Muar, 84000
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    Muar town 1732869, 84000
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    Sarawak Miri, 98000
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    Angeles City, 2009
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    Angeles City 1730737, 2009
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    Iloilo City, 5000
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    Bialystok 776069, 15-540
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    Riyadh 108410, 11426
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    Brezno, 977 01
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    Brezno 3060950, 977 01
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    Kosice, 04022
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    Košice 724443, 04022
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    Moldava nad Bodvou, 04501
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    Svidník 723417, 08901
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    Durban 1007311, 4001
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    Barcelona, 08003
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    Barcelona 3128760, 08003
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    Cordoba, 14004
    Spain

    Active - Recruiting

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    Madrid, 28041
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    Madrid 3117735, 28040
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    Oviedo, 33011
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    Santa Coloma de Gramenet, 08923
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    Santa Coloma de Gramenet 3109981, 08923
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    Terrassa (Barcelona), 08221
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    Terrassa (Barcelona) 3108286, 08221
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    Valencia, 46010
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    Valencia 2509954, 46010
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    New Taipei, 220
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    New Taipei City 12908892, 220
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    Taipei, 11217
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    Taipei 1668341, 11217
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    Taoyuan, 333
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    Taoyuan District 1667905, 333
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    Bangkok, 10330
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    Bangkok 1609350, 10400
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    Chiang Mai 1153671, 50200
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    Ankara, 06230
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    Istanbul, 34668
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    Kahramanmaras, 46100
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    Kayseri, 38039
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    Odunpazarı, 26080
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    Adana 325363, 01060
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    Ankara 323786, 06230
    Turkey (Türkiye)

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    Kahramanmaraş 310859, 46100
    Turkey (Türkiye)

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    Kayseri 308464, 38039
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    Odunpazari 10345207, 26080
    Turkey (Türkiye)

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    Canterbury, CT1 3NG
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    Corby, NN17 2UR
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    Corby 2652381, NN17 2UR
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    London, W6 7HY
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    London 2643743, W6 7HY
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    Prescot, L35 5DR
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    Prescot 2639928, L35 5DR
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    Stockport, SK2 7JE
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    Swindon, SN3 6BB
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    Swindon 2636389, SN3 6BB
    United Kingdom

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    Thetford, IP24 1JD
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    Thetford 2636032, IP24 1JD
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    Weston-Super-Mare, BS24 7PR
    United Kingdom

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    Weston-super-Mare 2634308, BS24 7PR
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    Yate, BS37 4AX
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    Yate 2633406, BS37 4AX
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    Surprise, Arizona 85374
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    Surprise 5316428, Arizona 5551752 85374
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    Huntington Park, California 90255
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    Los Angeles, California 90057
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    Hollywood, Florida 33024
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    Lake Worth, Florida 33467
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    Port Charlotte, Florida 33952
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    Tampa, Florida 33606
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    Hollywood 4158928, Florida 4155751 33024
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    Lake Worth 4161422, Florida 4155751 33467
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    Port Charlotte 4169130, Florida 4155751 33952
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    Fort Wayne, Indiana 46804
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    Fort Wayne 4920423, Indiana 4921868 46804
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    Lexington, Kentucky 40503
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    Lexington 4297983, Kentucky 6254925 40503
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    Baton Rouge, Louisiana 70808
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    Bronx, New York 10455
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    The Bronx 5110266, New York 5128638 10455
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    Greenville, North Carolina 27834
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    Jacksonville, North Carolina 28546
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    Kinston, North Carolina 28504
    United States

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    New Bern, North Carolina 28562
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    Wilmington, North Carolina 28401
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    Greenville 4469160, North Carolina 4482348 27834
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    Jacksonville 4473083, North Carolina 4482348 28546
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    Kinston 4474436, North Carolina 4482348 28504
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    New Bern 4481682, North Carolina 4482348 28562
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    Wilmington 4499379, North Carolina 4482348 28401
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    Langhorne, Pennsylvania 19047
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    Langhorne 5197140, Pennsylvania 6254927 19047
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    Brownsville, Texas 78526
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    Corpus Christi, Texas 78404
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    Lampasas, Texas 76550
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    Brownsville 4676740, Texas 4736286 78526
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    Corpus Christi 4683416, Texas 4736286 78404
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    Lampasas 4705176, Texas 4736286 76550
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    Hanoi, 100000
    Vietnam

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    Hanoi 1581130, 100000
    Vietnam

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    Ho Chi Minh, 700000
    Vietnam

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    Ho Chi Minh City 1566083, 700000
    Vietnam

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    Hochiminh City, 700000
    Vietnam

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