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 (BaxHTN)

A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

Study Overview

• Status: Completed
• Conditions: Resistant Hypertension; Uncontrolled Hypertension
• Intervention / Treatment: Drug: Baxdrostat; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 796
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina, C1119ACN
    • Research Site
  • CABA, Argentina, C1425AGC
    • Research Site
  • Ciudad de Buenos Aires, Argentina, AR-CP 1221
    • Research Site
  • Córdoba, Argentina, 5000
    • Research Site
  • Córdoba, Argentina, X5003DCP
    • Research Site
  • Mar del Plata, Argentina, B7600
    • Research Site
  • Mendoza, Argentina, M5500
    • Research Site
  • Rosario, Argentina, S2000PBJ
    • Research Site
  • San Miguel de Tucumán, Argentina, 4000
    • Research Site
  • San Nicolás, Argentina, B2900DMH
    • Research Site
  • San Vicente, Argentina, 5006
    • Research Site
• Australia
  • Clayton, Australia, 3168
    • Research Site
  • Darlinghurst, Australia, 2010
    • Research Site
  • Epping, Australia, 3076
    • Research Site
  • Geelong, Australia, 3220
    • Research Site
  • Liverpool, Australia, 2170
    • Research Site
  • New Lambton Heights, Australia, 2305
    • Research Site
  • Perth, Australia, 6000
    • Research Site
  • Wollongong, Australia, 2500
    • Research Site
  • Woolloongabba, Australia, 4102
    • Research Site
• Austria
  • Braunau am Inn, Austria, 5280
    • Research Site
  • Sankt Pölten, Austria, 3100
    • Research Site
  • Vienna, Austria, 1090
    • Research Site
• Belgium
  • Ghent, Belgium, 9000
    • Research Site
  • Liège, Belgium, 4000
    • Research Site
  • Mons, Belgium, 7000
    • Research Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Research Site
  • Sofia, Bulgaria, 1527
    • Research Site
  • Sofia, Bulgaria, 1618
    • Research Site
  • Sofia, Bulgaria, 1680
    • Research Site
  • Sofia, Bulgaria, 1709
    • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2C8
      • Research Site
  • British Columbia
    • North Vancouver, British Columbia, Canada, V7M 2H4
      • Research Site
  • Ontario
    • Cambridge, Ontario, Canada, N1R 6V6
      • Research Site
    • Markham, Ontario, Canada, L3S 0A2
      • Research Site
    • Newmarket, Ontario, Canada, L3Y 2P6
      • Research Site
    • Ottawa, Ontario, Canada, K1H 7W9
      • Research Site
    • Scarborough Village, Ontario, Canada, M1B 4Z8
      • Research Site
    • Toronto, Ontario, Canada, M6G 1M2
      • Research Site
    • Waterloo, Ontario, Canada, N2T 0C1
      • Research Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Research Site
    • Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1J2
      • Research Site
• Czechia
  • Benešov, Czechia, 256 01
    • Research Site
  • Brandýs nad Labem, Czechia, 250 01
    • Research Site
  • Broumov, Czechia, 55001
    • Research Site
  • Louny, Czechia, 440 01
    • Research Site
  • Ostrava, Czechia, 708 52
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  • Příbram, Czechia, 261 01
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  • Uherské Hradiště, Czechia, 68601
    • Research Site
• Denmark
  • Aarhus, Denmark, 8200
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  • Herning, Denmark, 7400
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  • Holbæk, Denmark, 4300
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• France
  • Bobigny, France, 93000
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  • Bordeaux, France, 33076
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  • Paris, France, 75015
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  • Paris, France, 75013
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  • Saint-Priest-en-Jarez, France, 42270
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  • Toulon, France, 83100
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  • Toulouse, France, 31059
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  • Tours, France, 37044
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• Germany
  • Bad Homburg, Germany, 61348
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  • Bad Oeynhausen, Germany, 32545
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  • Berlin, Germany, 12203
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  • Berlin, Germany, 13347
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  • Dortmund, Germany, 44137
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  • Düsseldorf, Germany, 40225
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  • Elsterwerda, Germany, 04910
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  • Erlangen, Germany, 91054
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  • Essen, Germany, 45355
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  • Frankfurt, Germany, 60596
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  • Frankfurt, Germany, 60590
    • Research Site
  • Hanover, Germany, 30449
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  • Hanover, Germany, 30625
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  • Homburg, Germany, 66424
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  • Kaiserslautern, Germany, 67655
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  • Leipzig, Germany, 04103
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  • Mannheim, Germany, 68167
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  • Wermsdorf, Germany, 04779
    • Research Site
• Hungary
  • Balatonfüred, Hungary, 8230
    • Research Site
  • Budapest, Hungary, 1115
    • Research Site
  • Kalocsa, Hungary, 6300
    • Research Site
  • Kaposvár, Hungary, 7400
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  • Nyíregyháza, Hungary, 4400
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  • Pécs, Hungary, 7623
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• India
  • Delhi, India, 110029
    • Research Site
  • Delhi, India, 110060
    • Research Site
  • Guntur, India, 522001
    • Research Site
  • Kanpur, India, 208002
    • Research Site
  • Kolkata, India, 700020
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  • Kolkata, India, 700014
    • Research Site
  • Mysuru, India, 570004
    • Research Site
  • Mysuru, India, 570015
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  • New Delhi, India, 110017
    • Research Site
  • New Delhi, India, 110002
    • Research Site
  • Surat, India, 395001
    • Research Site
• Israel
  • Ashdod, Israel, 7747629
    • Research Site
  • Haifa, Israel, 3109601
    • Research Site
  • Petah Tikva, Israel, 49100
    • Research Site
  • Ramat Gan, Israel, 52621
    • Research Site
  • Rehovot, Israel, 76100
    • Research Site
• Italy
  • Acquaviva delle Fonti, Italy, 70021
    • Research Site
  • Bologna, Italy, 40138
    • Research Site
  • Brescia, Italy, 25123
    • Research Site
  • Milan, Italy, 20138
    • Research Site
  • Milan, Italy, 20122
    • Research Site
  • Milan, Italy, 20149
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  • Pisa, Italy, 56126
    • Research Site
  • Roma, Italy, 00189
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  • Torino, Italy, 10126
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  • Udine, Italy, 33100
    • Research Site
• Japan
  • Adachi-ku, Japan, 121-0815
    • Research Site
  • Chūōku, Japan, 103-0027
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  • Chūōku, Japan, 260-0804
    • Research Site
  • Kanazawa, Japan, 920-8530
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  • Koga-shi, Japan, 306-0232
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  • Kyoto, Japan, 607-8062
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  • Nagasaki, Japan, 850-8555
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  • Okayama, Japan, 700-0804
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  • Osaka, Japan, 559-0012
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  • Sapporo, Japan, 003-0026
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  • Tsuchiura-shi, Japan, 300-0062
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  • Yufu-shi, Japan, 879-5593
    • Research Site
• Malaysia
  • Kajang, Malaysia, 43000
    • Research Site
  • Kota Bharu, Malaysia, 15586
    • Research Site
  • Kuching, Malaysia, 93586
    • Research Site
  • Malacca, Malaysia, 75400
    • Research Site
  • Muar town, Malaysia, 84000
    • Research Site
  • Sarawak Miri, Malaysia, 98000
    • Research Site
  • Seri Manjung, Malaysia, 32040
    • Research Site
• Netherlands
  • Hoogeveen, Netherlands, 7909 AA
    • Research Site
  • Nijmegen, Netherlands, 6525 GA
    • Research Site
  • Utrecht, Netherlands, 3508 AB
    • Research Site
• Poland
  • Bialystok, Poland, 15-540
    • Research Site
  • Bydgoszcz, Poland, 85-095
    • Research Site
  • Chrzanów, Poland, 32-500
    • Research Site
  • Gdansk, Poland, 80-214
    • Research Site
  • Gdynia, Poland, 81-338
    • Research Site
  • Krakow, Poland, 30-688
    • Research Site
  • Lodz, Poland, 91-002
    • Research Site
  • Poznan, Poland, 61-848
    • Research Site
  • Warsaw, Poland, 02-172
    • Research Site
  • Warsaw, Poland, 02-758
    • Research Site
  • Warsaw, Poland, 04-628
    • Research Site
• Slovakia
  • Brezno, Slovakia, 977 01
    • Research Site
  • Košice, Slovakia, 04022
    • Research Site
  • Moldava nad Bodvou, Slovakia, 04501
    • Research Site
  • Prešov, Slovakia, 080 01
    • Research Site
  • Rimavská Sobota, Slovakia, 979 01
    • Research Site
  • Svidník, Slovakia, 08901
    • Research Site
• South Africa
  • Cape Town, South Africa, 7500
    • Research Site
  • Centurion, South Africa, 0157
    • Research Site
  • Claremont, South Africa, 7708
    • Research Site
  • Durban, South Africa, 4001
    • Research Site
  • Kwadwesi, South Africa, 6201
    • Research Site
  • Somerset West, South Africa, 7130
    • Research Site
  • Worcester, South Africa, 6850
    • Research Site
• South Korea
  • Bucheon-si, South Korea, 420-717
    • Research Site
  • Busan, South Korea, 49241
    • Research Site
  • Daejeon, South Korea, 35015
    • Research Site
  • Incheon, South Korea, 21565
    • Research Site
  • Seoul, South Korea, 02841
    • Research Site
  • Seoul, South Korea, 03080
    • Research Site
  • Seoul, South Korea, 03722
    • Research Site
  • Seoul, South Korea, 04763
    • Research Site
  • Seoul, South Korea, 05505
    • Research Site
  • Seoul, South Korea, 07441
    • Research Site
  • Seoul, South Korea, 07804
    • Research Site
  • Seoul, South Korea, 08308
    • Research Site
• Spain
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, 08003
    • Research Site
  • Ferrol, Spain, 15405
    • Research Site
  • Granada, Spain, 18014
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Majadahonda, Spain, 28222
    • Research Site
  • Seville, Spain, 41004
    • Research Site
  • Terrassa (Barcelona), Spain, 08221
    • Research Site
• Sweden
  • Gothenburg, Sweden, 413 45
    • Research Site
  • Uppsala, Sweden, 75185
    • Research Site
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Research Site
  • Kaohsiung City, Taiwan, 81362
    • Research Site
  • Taichung, Taiwan, 40447
    • Research Site
  • Taichung, Taiwan, 40201
    • Research Site
  • Taichung, Taiwan, 433004
    • Research Site
  • Taipei, Taiwan, 10002
    • Research Site
  • Taipei, Taiwan, 11217
    • Research Site
  • Taipei, Taiwan, 110
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  • Yung Kang City, Taiwan, 71044
    • Research Site
• Thailand
  • Bangkok, Thailand, 10330
    • Research Site
  • Bangkok, Thailand, 10400
    • Research Site
  • Bangkok, Thailand, 10700
    • Research Site
  • Chiang Mai, Thailand, 50200
    • Research Site
  • Hat Yai, Thailand, 90110
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Research Site
  • Pathum Thani, Thailand, 12120
    • Research Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01060
    • Research Site
  • Ankara, Turkey (Türkiye), 06530
    • Research Site
  • Bursa, Turkey (Türkiye), 16059
    • Research Site
  • Dinar, Turkey (Türkiye), 03400
    • Research Site
  • Istanbul, Turkey (Türkiye), 34862
    • Research Site
  • Izmir, Turkey (Türkiye)
    • Research Site
  • Kütahya, Turkey (Türkiye), 43100
    • Research Site
  • Odunpazari, Turkey (Türkiye), 26080
    • Research Site
• United Kingdom
  • Bollington, United Kingdom, SK10 5JH
    • Research Site
  • Bristol, United Kingdom, BS34 6BQ
    • Research Site
  • Chesterfield, United Kingdom, S40 4AA
    • Research Site
  • Dundee, United Kingdom, DD1 9SY
    • Research Site
  • Glasgow, United Kingdom, G51 4TF
    • Research Site
  • Harrow, United Kingdom, HA3 7LT
    • Research Site
  • Hownslow, United Kingdom, TW3 3LN
    • Research Site
  • London, United Kingdom, EC1M 6BQ
    • Research Site
  • London, United Kingdom, W6 7HY
    • Research Site
  • Prescot, United Kingdom, L35 5DR
    • Research Site
  • Weston-super-Mare, United Kingdom, BS24 7PR
    • Research Site
  • Yate, United Kingdom, BS37 4AX
    • Research Site
• United States
  • Alabama
    • Saraland, Alabama, United States, 36571
      • Research Site
  • Arizona
    • Scottsdale, Arizona, United States, 85054
      • Research Site
    • Sun City West, Arizona, United States, 85375
      • Research Site
    • Surprise, Arizona, United States, 85374
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Research Site
  • California
    • Fresno, California, United States, 93720
      • Research Site
    • Lincoln, California, United States, 95648
      • Research Site
    • Orange, California, United States, 92868
      • Research Site
    • Rancho Cucamonga, California, United States, 91730
      • Research Site
    • Stanford, California, United States, 94304
      • Research Site
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Research Site
  • Florida
    • Clearwater, Florida, United States, 33765
      • Research Site
    • Jacksonville, Florida, United States, 32204
      • Research Site
    • Port Orange, Florida, United States, 32127
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30344
      • Research Site
    • Decatur, Georgia, United States, 30033
      • Research Site
  • Illinois
    • Springfield, Illinois, United States, 62702
      • Research Site
  • Indiana
    • Munster, Indiana, United States, 46321
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Research Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Research Site
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Research Site
    • Kansas City, Missouri, United States, 64128
      • Research Site
    • Kansas City, Missouri, United States, 64151
      • Research Site
  • New York
    • Rosedale, New York, United States, 11422
      • Research Site
    • The Bronx, New York, United States, 10455
      • Research Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Research Site
    • New Bern, North Carolina, United States, 28562
      • Research Site
  • Ohio
    • Toledo, Ohio, United States, 43614
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  • Oregon
    • Grants Pass, Oregon, United States, 97527
      • Research Site
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Research Site
    • Langhorne, Pennsylvania, United States, 19047
      • Research Site
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Research Site
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Research Site
  • Texas
    • Brownsville, Texas, United States, 78526
      • Research Site
    • Corpus Christi, Texas, United States, 78404
      • Research Site
    • Houston, Texas, United States, 77054
      • Research Site
    • Sugar Land, Texas, United States, 77479
      • Research Site
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Research Site
    • Suffolk, Virginia, United States, 23435
      • Research Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Research Site
    • Milwaukee, Wisconsin, United States, 53295
      • Research Site
• Vietnam
  • Da Nang, Vietnam, 550000
    • Research Site
  • Hanoi, Vietnam, 100000
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Research Site
  • Ho Chi Minh City, Vietnam, 70000
    • Research Site
  • Hochiminh City, Vietnam, 700000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female participants must be ≥ 18 years old
• 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 sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 mg baxdrostat; 2 mg baxdrostat administered orally, once daily (QD).	Drug: 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.; Other Names: CIN-107
Experimental: 1 mg baxdrostat; 1 mg baxdrostat administered orally, once daily (QD).	Drug: 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.; Other Names: CIN-107
Placebo Comparator: Placebo; Placebo administered orally, once daily (QD).	Drug: Placebo; Placebo tablet matching baxdrostat, administered orally, once daily (QD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in seated systolic blood pressure for 2 mg baxdrostat	To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12	At Week 12
Change from baseline in seated systolic blood pressure for 1 mg baxdrostat	To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12	At Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat	To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal	At Week 32
Change from baseline in seated SBP for 2 mg baxdrostat	To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation	At Week 12
Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat	To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12	At Week 12
Achieving seated SBP < 130 mmHg for 2 mg baxdrostat	To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12	At Week 12
Change from baseline in seated SBP for 1 mg baxdrostat	To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation	At Week 12
Change from baseline in seated DBP for 1 mg baxdrostat	To assess the effect of 1 mg baxdrostat vs placebo on seated DBP at Week 12	At Week 12
Achieving seated SBP < 130 mmHg for 1 mg baxdrostat	To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12	At Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)	To assess the safety and tolerability of baxdrostat versus placebo. Occurrence of adverse events (AE), including serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAE) and adverse events of special interest (AESI).	Up to Week 54

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Actual): May 21, 2025
• Study Completion (Actual): October 10, 2025

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hypertension; Blood pressure; Uncontrolled hypertension; Aldosterone; Resistant hypertension; Baxdrostat; CIN-107; Aldosterone synthase
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: D6970C00002; 2023-505499-32-00 (Registry Identifier: EU CT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No