2025-520740-16-00招募中3 期
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants with Primary Aldosteronism
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 25
- 主要终点
- 1. Change from baseline in seated SBP at Week 8
研究概览
简要总结
- To assess the effect of baxdrostat versus placebo on seated SBP at Week 8
- To assess the effect of baxdrostat versus placebo on achieving xxx at week 8 in participants xxx at baseline
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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 or potassium sparing diuretics per study requirement for participants taking 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 Screening determined 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.
排除标准
- •If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 180 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 2 weeks prior to Randomisation.
结局指标
主要结局
1. Change from baseline in seated SBP at Week 8
1. Change from baseline in seated SBP at Week 8
2. Achieving xxx at Week 8 in participants xxx at baseline
2. Achieving xxx at Week 8 in participants xxx at baseline
次要结局
- Change from RWD baseline (Week 44) in seated SBP at Week 52
- Percent change from RWD baseline (Week 44) in PRA at Week 52
- Achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 in participants with serum potassium < 3.7 mmol/L or potassium supplementation at baseline
- Percent change from baseline in PRA at Week 8
- Achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline
- Change from baseline in 24-hour urine albumin at Week 8
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (25)
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