2023-507640-36-00招募中3 期
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants with Resistant Hypertension.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 79
- 试验地点
- 47
- 主要终点
- Change from baseline in ambulatory 24‑hour average SBP at Week 12.
研究概览
简要总结
To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average systolic blood pressure (SBP) at Week 12.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 18 years old, at the time of signing the informed consent.
- •Mean seated SBP on AOBPM of ≥ 140 mmHg and < 170 mmHg at Screening.
- •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, for at least 4 weeks prior to Screening. Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
- •Have eGFR ≥ 45 mL/min/1.73 m2 at Screening.
- •Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening, determined as per central laboratory
- •Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.
排除标准
- •Mean seated SBP on AOBPM ≥ 170 mmHg.
- •Mean seated DBP on AOBPM ≥ 110 mmHg
- •Serum sodium level < 135 mmol/L at Screening, as per central laboratory.
- •Known secondary causes of hypertension.
- •New York Heart Association functional HF class IV
- •Persistent atrial fibrillation.
结局指标
主要结局
Change from baseline in ambulatory 24‑hour average SBP at Week 12.
Change from baseline in ambulatory 24‑hour average SBP at Week 12.
次要结局
- Change from baseline in ambulatory night-time average SBP at Week 12.
- Change from baseline in ambulatory daytime average SBP at Week 12.
- Change from baseline in seated SBP at Week 12.
- Participants achieving ambulatory 24-hour average SBP of < 130 mmHg at Week 12.
- Change from baseline in ambulatory 24-hour average DBP at Week 12.
- Change from baseline in ambulatory night-time average DBP at Week 12.
- Change from baseline in ambulatory daytime average DBP at Week 12.
- Change from baseline on seated DBP at Week 12.
- Participants achieving a nocturnal SBP dipping of ≥ 10% at Week 12
研究者
AstraZeneca Clinical Study Information Center
Scientific
Astrazeneca AB
研究点 (47)
Loading locations...
相似试验
已完成
3 期
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant HypertensionUncontrolled HypertensionResistant HypertensionNCT06344104AstraZeneca326
已完成
1 期
A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy ParticipantsHealthy ParticipantsNCT06194032AstraZeneca28
终止
2 期
Effect of Febuxostat Compared to Placebo on Exercise Tolerance in Participants With Chronic Stable AnginaAnginaNCT01549977Takeda1
已完成
2 期
Effect of Febuxostat on Blood PressureHypertensionNCT01496469Takeda121
已完成
2 期
A Study Assessing Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's DiseaseAlzheimer's DiseaseNCT02431468Neurotrope Bioscience, Inc.147