NCT07654140招募中2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Uncontrolled Hypertension
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 1
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of different doses of SAL0140 in uncontrolled hypertension.
详细描述
Participants diagnosed with uncontrolled hypertension were randomly assigned to the low-dose group, middle-dose group, high-dose group or placebo group for a double-blind treatment period. Participants subsequently entered a withdrawal period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-75 years old, male or female.
- •Mean seated systolic blood pressure (msSBP) at screening was ≥140 mmHg and <180 mmHg.
- •Meet either item A or B at screening: A. Uncontrolled hypertension (uHTN); B. Resistant hypertension (rHTN).
- •Mean seated systolic blood pressure (msSBP) prior to randomization was ≥140 mmHg and <180 mmHg.
- •Voluntarily participate in this study and sign the informed consent form.
- •Agree to comply with contraception and fertility restrictions of this study.
排除标准
- •Severe hypertension (msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg); malignant hypertension, hypertensive emergency, hypertensive crisis, hypertensive encephalopathy, etc.
- •Compliance with study drug during the run-in period was less than 80% or greater than 120%.
- •Hypertension complicated with the following conditions: acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, stroke.
- •Positive results for any of human immunodeficiency virus antibody (HIV), hepatitis C virus antibody (HCV), treponema pallidum antibody (TP); or positive hepatitis B surface antigen (HBsAg) with HBVDNA ≥ 1000 IU/mL.
- •Patients with active malignant tumors.
- •Patients receiving hemodialysis or adhering to strict salt restriction therapy.
- •History of adrenal insufficiency.
- •History of solid organ or bone marrow transplantation.
- •Gastrointestinal diseases or post-gastrointestinal surgery.
- •Known or suspected hypersensitivity to aldosterone synthase inhibitors; known or suspected contraindications or hypersensitivity to background medications.
- •History of drug abuse or alcohol abuse.
- •Blood donation or significant blood loss.
研究者
研究点 (1)
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