Actively Recruiting
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism
Led by AstraZeneca · Updated on 2026-04-20
250
Participants Needed
89
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of baxdrostat compared to a placebo in adults aged 18 years and older with Primary Aldosteronism (PA). This Phase III, multicenter, randomized, double-blind, placebo-controlled study aims to assess how baxdrostat affects seated blood pressure and the normalization of the Renin Angiotensin Aldosterone System (RAAS). The trial includes participants with or without prior treatment using Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Participants will receive either baxdrostat or a matching placebo tablet taken orally once daily. The dose may be increased after two weeks depending on how the participant responds and tolerates the treatment. The study is planned to take place globally across about 90 centers in 12 countries. Treatments will be compared over the course of the study to evaluate their effects on blood pressure and RAAS normalization. During the study, participants will have regular assessments including measurements of seated systolic blood pressure and monitoring of RAAS system function at week 8 and week 52. Blood potassium and aldosterone levels will also be tracked. Safety and tolerability will be monitored throughout the study. The total participation period includes initial treatment and follow-up assessments to observe changes and any side effects over time.
CONDITIONS
Brief Title
A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants must be 18 years of age or older
- Documented diagnosis of Primary Aldosteronism according to 2016 or 2025 Endocrine Society Guidelines
- Willing and able to stop taking Mineralocorticoid Receptor Antagonists or potassium-sparing diuretics as required at screening
- Estimated glomerular filtration rate (eGFR) of 45 mL/min/1.73m2 or higher at screening
- Serum potassium level between 3.0 and less than 5.0 mmol/L at screening
- Stable regimen of antihypertensive medications for at least 4 weeks before randomization
- Mean seated systolic blood pressure between 135 and 170 mmHg and diastolic blood pressure 105 mmHg or lower
- Serum potassium greater than 3.0 mmol/L at randomization
You will not qualify if you...
- If not taking Mineralocorticoid Receptor Antagonists or potassium-sparing diuretics at screening: mean seated systolic blood pressure over 170 mmHg or diastolic blood pressure over 105 mmHg
- If taking Mineralocorticoid Receptor Antagonists or potassium-sparing diuretics at screening: mean seated systolic blood pressure over 160 mmHg or diastolic blood pressure 100 mmHg or higher
- Previous adrenal surgery or planned adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the study
- Known secondary causes of hypertension including renal artery stenosis, uncontrolled or untreated hyperthyroidism or hypothyroidism, pheochromocytoma, Cushing's syndrome, or aortic coarctation
- Serum sodium level below 135 mmol/L at screening
- New York Heart Association functional heart failure class IV at screening
- Persistent atrial fibrillation
- Treatment with any Mineralocorticoid Receptor Antagonist or potassium-sparing diuretic within 2 weeks before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take Baxdrostat or placebo tablets orally once daily to assess the efficacy and safety in managing Primary Aldosteronism.
Regular visits during the 8-week treatment period
Duration - Up to 44 weeks following initial treatment
Participants are monitored after the initial treatment period to evaluate longer-term effects and safety.
Visits up to Week 52 for ongoing assessments
Trial Site Locations
Total: 89 locations
1
Research Site
Los Angeles, California, United States, 90048
Not Yet Recruiting
2
Research Site
San Francisco, California, United States, 94110
Not Yet Recruiting
3
Research Site
Farmington, Connecticut, United States, 06030
Not Yet Recruiting
4
Research Site
Chicago, Illinois, United States, 60611
Not Yet Recruiting
5
Research Site
Springfield, Illinois, United States, 62702
Actively Recruiting
6
Research Site
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
7
Research Site
Boston, Massachusetts, United States, 02111
Actively Recruiting
8
Research Site
Boston, Massachusetts, United States, 02115
Actively Recruiting
9
Research Site
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
Research Site
Rochester, Minnesota, United States, 55902
Actively Recruiting
11
Research Site
Olive Branch, Mississippi, United States, 38654
Actively Recruiting
12
Research Site
Kansas City, Missouri, United States, 64151
Withdrawn
13
Research Site
New York, New York, United States, 10065
Not Yet Recruiting
14
Research Site
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
15
Research Site
Columbus, Ohio, United States, 43210
Actively Recruiting
16
Research Site
Portland, Oregon, United States, 97239
Withdrawn
17
Research Site
Bethlehem, Pennsylvania, United States, 18017
Actively Recruiting
18
Research Site
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
19
Research Site
Columbia, South Carolina, United States, 29203
Actively Recruiting
20
Research Site
Brownsville, Texas, United States, 78526
Withdrawn
21
Research Site
Dallas, Texas, United States, 75390
Actively Recruiting
22
Research Site
Brisbane, Australia, 4102
Actively Recruiting
23
Research Site
Clayton, Australia, 3168
Actively Recruiting
24
Research Site
Perth, Australia, 6000
Actively Recruiting
25
Research Site
Calgary, Alberta, Canada, T2T 5C7
Actively Recruiting
26
Research Site
Ottawa, Ontario, Canada, K1H 7W9
Actively Recruiting
27
Research Site
Toronto, Ontario, Canada, M4G 3E8
Actively Recruiting
28
Research Site
Montreal, Quebec, Canada, H4J 1C5
Actively Recruiting
29
Research Site
Beijing, China, 100034
Actively Recruiting
30
Research Site
Beijing, China, 100044
Actively Recruiting
31
Research Site
Beijing, China, 100191
Actively Recruiting
32
Research Site
Changsha, China, 430033
Actively Recruiting
33
Research Site
Chengdu, China, 610041
Actively Recruiting
34
Research Site
Chengdu, China, 610500
Withdrawn
35
Research Site
Chongqing, China, 400042
Actively Recruiting
36
Research Site
Nanjing, China, 2100008
Actively Recruiting
37
Research Site
Shanghai, China, 200025
Actively Recruiting
38
Research Site
Tianjin, China, 300050
Actively Recruiting
39
Research Site
Wuhan, China, 430030
Actively Recruiting
40
Research Site
Wuhan, China, 430060
Actively Recruiting
41
Research Site
Xianyang, China, 750004
Actively Recruiting
42
Research Site
Amiens, France, 80054
Actively Recruiting
43
Research Site
Bois-Guillaume, France, 76230
Actively Recruiting
44
Research Site
Bordeaux, France, 33076
Actively Recruiting
45
Research Site
Lille, France, 59037
Actively Recruiting
46
Research Site
Marseille, France, 13005
Actively Recruiting
47
Research Site
Paris, France, 75018
Actively Recruiting
48
Research Site
Paris, France, 75908
Actively Recruiting
49
Research Site
Berlin, Germany, 12203
Actively Recruiting
50
Research Site
Düsseldorf, Germany, 40225
Actively Recruiting
51
Research Site
Kaiserslautern, Germany, 67655
Actively Recruiting
52
Research Site
München, Germany, 80336
Actively Recruiting
53
Research Site
Reinfeld (Holstein), Germany, 23858
Actively Recruiting
54
Research Site
Würzburg, Germany, 97080
Actively Recruiting
55
Research Site
Belagavi, India, 590010
Actively Recruiting
56
Research Site
Delhi, India, 110029
Actively Recruiting
57
Research Site
Hyderabad, India, 500012
Actively Recruiting
58
Research Site
Kolkata, India, 700020
Actively Recruiting
59
Research Site
Mumbai, India, 400008
Not Yet Recruiting
60
Research Site
Mumbai, India, 400012
Actively Recruiting
61
Research Site
Bologna, Italy, 40138
Actively Recruiting
62
Research Site
Brescia, Italy, 25123
Actively Recruiting
63
Research Site
Florence, Italy, 50134
Actively Recruiting
64
Research Site
Milan, Italy, 20149
Actively Recruiting
65
Research Site
Milan, Italy, 20162
Actively Recruiting
66
Research Site
Torino, Italy, 10126
Actively Recruiting
67
Research Site
Kawasaki-shi, Japan, 216-8511
Actively Recruiting
68
Research Site
Kodaira-shi, Japan, 187-8510
Actively Recruiting
69
Research Site
Minatoku, Japan, 108-8329
Actively Recruiting
70
Research Site
Ōta-ku, Japan, 143-8541
Actively Recruiting
71
Research Site
Shinjuku-ku, Japan, 162-8666
Actively Recruiting
72
Research Site
Yokohama, Japan, 230-8765
Actively Recruiting
73
Research Site
Yufu-shi, Japan, 879-5593
Actively Recruiting
74
Research Site
Barcelona, Spain, 08036
Actively Recruiting
75
Research Site
Madrid, Spain, 28034
Actively Recruiting
76
Research Site
Madrid, Spain, 28040
Actively Recruiting
77
Research Site
Madrid, Spain, 28046
Actively Recruiting
78
Research Site
Seville, Spain, 41013
Actively Recruiting
79
Research Site
Kaohsiung City, Taiwan, 80756
Actively Recruiting
80
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
81
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
82
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
83
Research Site
Yunlin, Taiwan, 640
Actively Recruiting
84
Research Site
Zhubei, Taiwan, 302
Actively Recruiting
85
Research Site
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
86
Research Site
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
87
Research Site
Dundee, United Kingdom, DD1 9SY
Actively Recruiting
88
Research Site
London, United Kingdom, EC1A 7BE
Actively Recruiting
89
Research Site
London, United Kingdom, SE1 9RT
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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