NCT07704684已完成3 期
Efficacy and Safety of Sacubitril/Allisartan and Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine: A Phase III, Multicenter, Randomized, Double-blind, Parallel-controlled, 52-week Clinical Study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- The baseline change in mean seated systolic blood pressure (msSBP)
研究概览
简要总结
The main objective of the study will be to assess the efficacy and safety of Sacubitril/Allisartan (240mg) and Amlodipine (5mg) in patients with essential hypertension uncontrolled after 4-week treatment with Amlodipine (5mg).
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.
- •Confirmed diagnosis of essential hypertension.
- •Patients who meet one of the following criteria when screening:
- •A. Treatment-naive patients (newly diagnosed essential hypertension, or patients with a prior hypertension history who have not taken any antihypertensive medication for at least 4 weeks prior to screening): mean seated systolic blood pressure (msSBP) ≥150 mmHg and <180 mmHg.
- •B. Patients with irregular oral administration of amlodipine besylate (5 mg once daily) (treatment duration less than 4 weeks before screening, or more than 5 missed dosing days within the 4 weeks prior to screening): msSBP ≥140 mmHg and<180 mmHg.
- •C. Patients on existing stable antihypertensive therapy (receiving a stable dose of another single-agent antihypertensive, free combination of two single-agent drugs, or single-pill fixed-dose combination containing two active ingredients for at least 4 weeks prior to screening): msSBP ≥140 mmHg and <180 mmHg, and the physician determines that switching treatment to amlodipine besylate (5 mg once daily) is clinically appropriate.
- •D. Patients with essential hypertension who have been regularly treated with amlodipine besylate (5mg once daily) for ≥4 weeks and have msSBP ≥140 mmHg and<180 mmHg. The previously regularly administered product shall be Norvasc® or generic amlodipine besylate that has passed the generic consistency evaluation in China.
- •At randomization, subjects must have msSBP ≥140 mmHg and <180 mmHg.
- •Subjects voluntarily participate in the trial and sign the written informed consent form.
- •For subjects enrolled for ambulatory blood pressure monitoring (ABPM): in addition to all above inclusion criteria, one further requirement must be satisfied: valid ABPM report with a 24-hour average blood pressure ≥130/80 mmHg. (Subjects failing to meet Criterion 6 remain eligible for the main trial without ABPM testing.)
排除标准
- •Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg).
- •History or confirmed diagnosis of secondary hypertension.
- •Concomitant use of three or more types of antihypertensive agents.
- •Personal history of angioedema induced by drugs or other causes.
- •Clinically significant abnormal laboratory findings, including but not limited to: serum potassium >5.5 mmol/L or <3.5 mmol/L; serum ALT and/or AST >2.5 × upper limit of normal (ULN); serum creatinine >1.5 × ULN; any other clinically significant laboratory abnormality deemed by the investigator likely to confound efficacy and/or safety assessment of the study.
- •Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus .
- •Subjects with active malignant tumor.
- •History of substance abuse or excessive alcohol consumption within 6 months prior to screening.
- •Blood donation or major blood loss (>400 mL) within 3 months prior to screening, or clinically diagnosed hypovolemia.
- •Participation in any interventional clinical trial with investigational medicinal product or medical device within 3 months prior to screening.
- •Drug compliance during run-in period <80% or >120%.
- •Any other conditions deemed inappropriate for trial enrollment by the investigator that may interfere with efficacy and/or safety evaluation of the study, including but not limited to anticipated poor subject compliance or impractical regular follow-up due to long residential distance.
结局指标
主要结局
The baseline change in mean seated systolic blood pressure (msSBP)
时间窗: at 12 weeks
Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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