Clinical Trials List
Protocol NumberD6974C00001
NCT Number(ClinicalTrials.gov Identfier)NCT07007793
Active
2025-07-01 - 2028-12-31
Phase III
Recruiting6
ICD-10E26.01
Conn's syndrome
ICD-10E26.02
Glucocorticoid-remediable aldosteronism
ICD-10E26.09
Other primary hyperaldosteronism
ICD-10E26.1
Secondary hyperaldosteronism
ICD-10E26.81
Bartter's syndrome
ICD-10E26.89
Other hyperaldosteronism
ICD-10E26.9
Hyperaldosteronism, unspecified
ICD-9255.1
Hyperaldosteronism
A randomized, double-blind, placebo-controlled, parallel-group trial was conducted to evaluate the efficacy and safety of Baxdrostat in adult subjects with primary hyperaldosteronism.
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Trial Applicant
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Sponsor
AstraZeneca Taiwan Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/23
Investigators and Locations
Co-Principal Investigator
- 呂菁 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃道民 Division of General Internal Medicine
- CHUN-FU LAI Division of General Internal Medicine
- 陳怡婷 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 溫振宇 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 郭美娟 Division of Nephrology
- Yi wen chiu Division of Nephrology
- 洪啟智 Division of Nephrology
- Yi-Chun Tsai Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
劉鳳炫
Co-Principal Investigator
- 陳怡文 Division of Endocrinology
- Kun-Hua Tu Division of Nephrology
- 林怡瑄 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
- Changes in sit-and-reach systolic blood pressure (SBP) at week 8 since baseline - Subjects whose plasma renin activity (PRA) was suppressed (< 1 μg/L/h) at baseline achieved unsuppressed plasma renin activity (PRA) (≥ 1 μg/L/h) at week 8.
Objectives
The aim of this trial was to evaluate the efficacy and safety of baxdrostat compared to placebo in patients with primary aldosteronism. The primary objective was to assess the effect of increasing baxdrostat from an initial dose of 2 mg to 4 mg compared to placebo in reducing systolic blood pressure and achieving uninhibited plasma renin activity in patients with primary aldosteronism.
Test Drug
Baxdrostat
Active Ingredient
C02KN02000
Dosage Form
Tablets
Dosage
1mg; 2mg
Endpoints
- Changes in sit-and-reach systolic blood pressure (SBP) since baseline at week 8
- Subjects whose plasma renin activity (PRA) was suppressed (< 1 μg/L/h) at baseline achieved unsuppressed plasma renin activity (PRA) (≥ 1 μg/L/h) at week 8.
- Subjects whose plasma renin activity (PRA) was suppressed (< 1 μg/L/h) at baseline achieved unsuppressed plasma renin activity (PRA) (≥ 1 μg/L/h) at week 8.
Inclution Criteria
Participants must meet all of the following criteria to be eligible for this trial:
Age
1. Male or female participants must be ≥ 18 years old at the time of signing the participant consent form.
Participant Type and Disease Characteristics
2. Participants must have a record of meeting the diagnostic criteria for primary hyperaldosteronism (PA) as defined in the 2016 or 2025 Endocrine Society guidelines.
Note: Patients with unilateral adrenal adenoma who may qualify for curative adrenalectomy may choose not to undergo surgery or postpone surgery. In this case, they are also eligible for this trial.
3. Participants currently using mineral corticosteroid receptor antagonists (MRAs) or potassium-sparing diuretics must be willing and able to comply with the trial requirements to discontinue MRAs or potassium-sparing diuretics.
4. Central laboratory testing shows an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m² at the time of screening (see Section 8.3.4). 5. The central laboratory determines that the serum potassium concentration at screening is ≥ 3.0 and < 5.0 mmol/L. If the potassium concentration at screening is < 3.0 or ≥ 5.0 mmol/L, this test will be repeated. If the subject's serum potassium concentration is < 3.5 mmol/L, potassium supplementation will be provided to correct the serum potassium concentration at the discretion of the trial administrator, and the subject may continue to participate in the trial. For detailed information on laboratory potassium measurement, please refer to Section 8.3.4.1.
Gender and Contraception/Barrier Method Requirements
6. Subjects designated as female at birth, including all gender identities: The contraceptive method used by the female should comply with local regulations regarding contraceptive methods for clinical trial subjects.
a) Female Subjects:
(i) A woman who is infertile is defined as a woman who has undergone permanent sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or is postmenopausal. A woman who has not menstruated for 12 months prior to the scheduled randomization date and has no other medical reason will be considered postmenopausal. The following age-specific requirements must be met:
(ii) Women < 50 years of age are considered postmenopausal if they have not menstruated for 12 months or longer after stopping exogenous hormone therapy and their follicle-stimulating hormone (FSH) levels are within the postmenopausal range.
(iii) Women ≥ 50 years of age are considered postmenopausal if they have not menstruated for 12 months or longer after stopping all exogenous hormone therapy.
(iv) Women of fertility must use a highly effective method of contraception. A highly effective method of contraception is defined as one that, when used correctly and consistently, achieves an annual failure rate of less than 1%. Throughout the trial, until at least 30 days after the last dose of trial treatment, women of fertility who have sexual intercourse with an unsterilized male partner must consent to the use of a highly effective method of contraception, as defined below.
(v) The following are not acceptable methods of contraception: male or female condoms, periodic abstinence (e.g., the rhythm method, ovulation method, sympathobiasis, post-ovulation method, claims of abstinence during the trial treatment), withdrawal (coitus interruptus), spermicide-only methods, and lactational amenorrhea.
(vi) At the time of screening, all women of fertility must have a negative pregnancy test (serum) and must not be breastfeeding.
(vii) Highly effective methods of contraception include: complete abstinence is acceptable as a method of contraception, provided it is the subject's usual lifestyle (defined as abstinence from sexual intercourse with the opposite sex throughout the entire risk period related to the trial treatment); the partner has undergone vasectomy; Implanon®; bilateral tubal ligation; intrauterine devices/levonorgestrel intrauterine contraceptive systems; Depo-Provera™ injections; ovulation-suppressing oral contraceptives; and Evra Patch™, Xulane™, or NuvaRing®.
Informed Consent
7. The ability to provide signed informed consent forms (as described in Appendix A3) that include compliance with the Subject Consent Form (ICF) and the requirements and limitations set forth in this trial protocol.
8. Before collecting specimens for selective genomic studies related to the genomics project, a signed and dated selective genomics project study information and informed consent form (see Appendix D2) will be provided.
Additional Randomization Criteria for the Second Visit
To be eligible for trial randomization, subjects must meet all screening criteria at the first visit and the following additional randomization criteria at the second visit:
9. Mean sitting systolic blood pressure (SBP) ≥ 135 mmHg using automated in-clinic blood pressure measurement (AOBPM). Note that if a subject completes the MRA clearance period and SBP < 135 mmHg, this visit will be considered the 1.5th visit, and the subject will undergo an additional 2-week MRA clearance period (Section 1.3). In this case, the second follow-up visit will be performed 2 weeks after the start of the extended clearance period (Section 4.1.1). For blood pressure (BP) measurement procedures, please refer to Section 8.2.1.
10. Patients must have been on stable antihypertensive medication for at least 4 weeks prior to randomization (including patients not using any antihypertensive medication).
11. Serum potassium > 3.0 mmol/L (Section 8.3.4.1).
Age
1. Male or female participants must be ≥ 18 years old at the time of signing the participant consent form.
Participant Type and Disease Characteristics
2. Participants must have a record of meeting the diagnostic criteria for primary hyperaldosteronism (PA) as defined in the 2016 or 2025 Endocrine Society guidelines.
Note: Patients with unilateral adrenal adenoma who may qualify for curative adrenalectomy may choose not to undergo surgery or postpone surgery. In this case, they are also eligible for this trial.
3. Participants currently using mineral corticosteroid receptor antagonists (MRAs) or potassium-sparing diuretics must be willing and able to comply with the trial requirements to discontinue MRAs or potassium-sparing diuretics.
4. Central laboratory testing shows an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m² at the time of screening (see Section 8.3.4). 5. The central laboratory determines that the serum potassium concentration at screening is ≥ 3.0 and < 5.0 mmol/L. If the potassium concentration at screening is < 3.0 or ≥ 5.0 mmol/L, this test will be repeated. If the subject's serum potassium concentration is < 3.5 mmol/L, potassium supplementation will be provided to correct the serum potassium concentration at the discretion of the trial administrator, and the subject may continue to participate in the trial. For detailed information on laboratory potassium measurement, please refer to Section 8.3.4.1.
Gender and Contraception/Barrier Method Requirements
6. Subjects designated as female at birth, including all gender identities: The contraceptive method used by the female should comply with local regulations regarding contraceptive methods for clinical trial subjects.
a) Female Subjects:
(i) A woman who is infertile is defined as a woman who has undergone permanent sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or is postmenopausal. A woman who has not menstruated for 12 months prior to the scheduled randomization date and has no other medical reason will be considered postmenopausal. The following age-specific requirements must be met:
(ii) Women < 50 years of age are considered postmenopausal if they have not menstruated for 12 months or longer after stopping exogenous hormone therapy and their follicle-stimulating hormone (FSH) levels are within the postmenopausal range.
(iii) Women ≥ 50 years of age are considered postmenopausal if they have not menstruated for 12 months or longer after stopping all exogenous hormone therapy.
(iv) Women of fertility must use a highly effective method of contraception. A highly effective method of contraception is defined as one that, when used correctly and consistently, achieves an annual failure rate of less than 1%. Throughout the trial, until at least 30 days after the last dose of trial treatment, women of fertility who have sexual intercourse with an unsterilized male partner must consent to the use of a highly effective method of contraception, as defined below.
(v) The following are not acceptable methods of contraception: male or female condoms, periodic abstinence (e.g., the rhythm method, ovulation method, sympathobiasis, post-ovulation method, claims of abstinence during the trial treatment), withdrawal (coitus interruptus), spermicide-only methods, and lactational amenorrhea.
(vi) At the time of screening, all women of fertility must have a negative pregnancy test (serum) and must not be breastfeeding.
(vii) Highly effective methods of contraception include: complete abstinence is acceptable as a method of contraception, provided it is the subject's usual lifestyle (defined as abstinence from sexual intercourse with the opposite sex throughout the entire risk period related to the trial treatment); the partner has undergone vasectomy; Implanon®; bilateral tubal ligation; intrauterine devices/levonorgestrel intrauterine contraceptive systems; Depo-Provera™ injections; ovulation-suppressing oral contraceptives; and Evra Patch™, Xulane™, or NuvaRing®.
Informed Consent
7. The ability to provide signed informed consent forms (as described in Appendix A3) that include compliance with the Subject Consent Form (ICF) and the requirements and limitations set forth in this trial protocol.
8. Before collecting specimens for selective genomic studies related to the genomics project, a signed and dated selective genomics project study information and informed consent form (see Appendix D2) will be provided.
Additional Randomization Criteria for the Second Visit
To be eligible for trial randomization, subjects must meet all screening criteria at the first visit and the following additional randomization criteria at the second visit:
9. Mean sitting systolic blood pressure (SBP) ≥ 135 mmHg using automated in-clinic blood pressure measurement (AOBPM). Note that if a subject completes the MRA clearance period and SBP < 135 mmHg, this visit will be considered the 1.5th visit, and the subject will undergo an additional 2-week MRA clearance period (Section 1.3). In this case, the second follow-up visit will be performed 2 weeks after the start of the extended clearance period (Section 4.1.1). For blood pressure (BP) measurement procedures, please refer to Section 8.2.1.
10. Patients must have been on stable antihypertensive medication for at least 4 weeks prior to randomization (including patients not using any antihypertensive medication).
11. Serum potassium > 3.0 mmol/L (Section 8.3.4.1).
Exclusion Criteria
Subjects must not participate in the trial if they meet any of the following criteria: Medical Conditions
1. There is any evidence, as determined by the trial administrator, that the subject is unfit to participate in the trial.
2. If MRA or potassium-sparing diuretics were not used at screening: mean sitting SBP > 180 mmHg or mean sitting diastolic blood pressure (DBP) ≥ 110 mmHg (according to AOBPM).
If MRA or potassium-sparing diuretics were used at screening: mean sitting SBP > 160 mmHg or mean sitting DBP ≥ 100 mmHg.
For BP measurement procedures, please refer to Section 8.2.1.
3. Has undergone adrenal adenoma surgery, or is scheduled to undergo adrenalectomy, renal sympathetic nerve block, or adrenal ablation during the trial. Note: Subjects who have undergone surgery within 6 months prior to screening, but whose serum/plasma aldosterone levels remain elevated (>15 ng/dL) and who meet BP and other eligibility criteria, may be considered for inclusion.
4. Subjects with any of the following known secondary causes of hypertension (HTN): renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, or aortic coarctation.
5. Serum sodium concentration <135 mmol/L as determined by a central laboratory at screening.
6. New York Heart Association Heart Failure (HF) functional classification IV at screening.
7. A history of stroke, acute coronary syndrome, hypertensive encephalopathy, or hospitalization for HF within 6 months prior to screening.
8. Planned percutaneous coronary intervention/coronary artery bypass graft (CABG), or having undergone CABG within the past 6 months prior to screening.
9. Known for severe left ventricular outflow occlusion, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valve disease.
10. Persistent atrial fibrillation.
11. Known for severe hepatic impairment, defined as Child-Pugh C, based on confirmed medical history.
12. Uncontrolled diabetes mellitus with HbA1c > 10.0% (86 mmol/mol) at screening.
13. Resting heart rate < 45 or > 110 beats per minute, based on vital signs assessment.
14. Subjects suspected of having severe cardiac hypertrophy.
15. Subjects who are pregnant or breastfeeding.
16. Subjects diagnosed with adrenal insufficiency.
Previous/Concomitant Therapies
17. Received any MRA or potassium-sparing diuretic within 2 weeks prior to randomization.
18. Currently or previously (within 4 weeks prior to screening) received concomitant treatment with angiotensin receptor blockers and angiotensin-converting enzyme inhibitors (ACEIs).
19. Received potassium-binding agent therapy within 2 months prior to screening.
20. Expected to receive or currently receiving any medication that would exclude eligibility for the trial, such as potent CYP3A inducers, chronic (more than 3 times per week for more than 3 months) use of nonsteroidal anti-inflammatory drugs (NSAIDs) (low-dose aspirin may be permitted at medical discretion), MRAs, and/or chronic use of systemic steroids.
21. Currently or within 6 months prior to screening received cytotoxic therapy. For concomitant medications that are prohibited during the trial, please refer to Section 6.9.1.
Previous/Concurrent Clinical Trial Experience
22. Subjects with a known hypersensitivity to baxdrostat or similar drugs or any drug excipients.
23. Participation in another clinical trial using baxdrostat or other investigational drugs within 3 months prior to randomization in this trial.
Other Exclusion Criteria
24. Involvement in the planning and/or execution of this trial (applicable to AstraZeneca employees and/or trial center personnel).
25. Subjects should not participate in the trial if the trial administrator determines that they cannot comply with the trial procedures, restrictions, and requirements.
26. Subjects have previously been randomized in this trial.
27. Female only – currently pregnant (confirmed pregnancy test) or breastfeeding.
28. Subjects work shifts (i.e., different shifts on different days).
1. There is any evidence, as determined by the trial administrator, that the subject is unfit to participate in the trial.
2. If MRA or potassium-sparing diuretics were not used at screening: mean sitting SBP > 180 mmHg or mean sitting diastolic blood pressure (DBP) ≥ 110 mmHg (according to AOBPM).
If MRA or potassium-sparing diuretics were used at screening: mean sitting SBP > 160 mmHg or mean sitting DBP ≥ 100 mmHg.
For BP measurement procedures, please refer to Section 8.2.1.
3. Has undergone adrenal adenoma surgery, or is scheduled to undergo adrenalectomy, renal sympathetic nerve block, or adrenal ablation during the trial. Note: Subjects who have undergone surgery within 6 months prior to screening, but whose serum/plasma aldosterone levels remain elevated (>15 ng/dL) and who meet BP and other eligibility criteria, may be considered for inclusion.
4. Subjects with any of the following known secondary causes of hypertension (HTN): renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, or aortic coarctation.
5. Serum sodium concentration <135 mmol/L as determined by a central laboratory at screening.
6. New York Heart Association Heart Failure (HF) functional classification IV at screening.
7. A history of stroke, acute coronary syndrome, hypertensive encephalopathy, or hospitalization for HF within 6 months prior to screening.
8. Planned percutaneous coronary intervention/coronary artery bypass graft (CABG), or having undergone CABG within the past 6 months prior to screening.
9. Known for severe left ventricular outflow occlusion, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valve disease.
10. Persistent atrial fibrillation.
11. Known for severe hepatic impairment, defined as Child-Pugh C, based on confirmed medical history.
12. Uncontrolled diabetes mellitus with HbA1c > 10.0% (86 mmol/mol) at screening.
13. Resting heart rate < 45 or > 110 beats per minute, based on vital signs assessment.
14. Subjects suspected of having severe cardiac hypertrophy.
15. Subjects who are pregnant or breastfeeding.
16. Subjects diagnosed with adrenal insufficiency.
Previous/Concomitant Therapies
17. Received any MRA or potassium-sparing diuretic within 2 weeks prior to randomization.
18. Currently or previously (within 4 weeks prior to screening) received concomitant treatment with angiotensin receptor blockers and angiotensin-converting enzyme inhibitors (ACEIs).
19. Received potassium-binding agent therapy within 2 months prior to screening.
20. Expected to receive or currently receiving any medication that would exclude eligibility for the trial, such as potent CYP3A inducers, chronic (more than 3 times per week for more than 3 months) use of nonsteroidal anti-inflammatory drugs (NSAIDs) (low-dose aspirin may be permitted at medical discretion), MRAs, and/or chronic use of systemic steroids.
21. Currently or within 6 months prior to screening received cytotoxic therapy. For concomitant medications that are prohibited during the trial, please refer to Section 6.9.1.
Previous/Concurrent Clinical Trial Experience
22. Subjects with a known hypersensitivity to baxdrostat or similar drugs or any drug excipients.
23. Participation in another clinical trial using baxdrostat or other investigational drugs within 3 months prior to randomization in this trial.
Other Exclusion Criteria
24. Involvement in the planning and/or execution of this trial (applicable to AstraZeneca employees and/or trial center personnel).
25. Subjects should not participate in the trial if the trial administrator determines that they cannot comply with the trial procedures, restrictions, and requirements.
26. Subjects have previously been randomized in this trial.
27. Female only – currently pregnant (confirmed pregnancy test) or breastfeeding.
28. Subjects work shifts (i.e., different shifts on different days).
The Estimated Number of Participants
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Taiwan
30 participants
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Global
250 participants
