Clinical Trials List
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 Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism
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Trial Applicant
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Sponsor
AstraZeneca
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
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
- CHUN-FU LAI Division of General Internal Medicine
- 黃道民 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
- 洪啟智 Division of Nephrology
- Yi wen chiu Division of Nephrology
- Yi-Chun Tsai Division of Nephrology
- 郭美娟 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kun-Hua Tu Division of Nephrology
- 林怡瑄 Division of Endocrinology
- 陳怡文 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
-Achieving normalization of the Renin Angiotensin Aldosterone system (RAAS) at week 8
Inclution Criteria
-Male or female participants must be ≥ 18 years of age
-Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.
-Participants willing and able to cease dosing of MRA orpotassium sparing diuretics per study requirement for participantstaking an MRA or potassium sparing diuretic at Screening.
-eGFR ≥ 45 mL/min/1.73m2 at Screening
-Serum potassium level ≥ 3.0 and < 5.0 mmol/L at Screeningdetermined as per the central laboratory.
-Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation
-Mean seated SBP on AOBPM of ≥ 135 mmHg.
Exclusion Criteria
- If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 170 mmHg or mean seated DBP ≥110 mmHg (on AOBPM).
-If taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 160 mmHg or mean seated DBP ≥ 100 mmHg.
-Previous surgical intervention for an adrenal adenoma or have a planned adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
-Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
-Serum sodium level < 135 mmol/L at Screening, determined as per central laboratory.
-New York Heart Association functional HF class IV at Screening.
-Persistent atrial fibrillation.
-Treatment with any MRA or potassium-sparing diuretic within 2weeks prior to Randomisation.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
180 participants
