Efficacy and Safety of Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine or Allisartan Isoproxil: A Phase III, Multicenter, Randomized, Double-blind, Parallel-controlled, 52-week Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 499
- 试验地点
- 1
- 主要终点
- Change from baseline in mean sitting systolic blood pressure after 12 weeks of randomized, double-blind treatment
研究概览
简要总结
The main objective of the study will be to assess the efficacy and safety of Allisartan Isoproxil/Amlodipine (240 mg/5 mg) in patients with mild to moderate essential hypertension uncontrolled after 4-week treatment with Amlodipine besylate（5 mg) or Allisartan Isoproxil (240 mg).
详细描述
Amlodipine belongs to the calcium channel blocker (CCB) class of drugs, which acts as an antihypertensive agent mainly via blocking calcium channels on the vascular smooth muscle cells to dilate blood vessels.
Allisartan Isoproxil belongs to the ARB class of drugs, which can effectively exert antihypertensive effects.
The combination of dihydropyridine CCBs and ARBs exerts synergistic antihypertensive effects.
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)
盲法说明
Double-blind treatment (Week 4~Week 16):
Open-label period(Week 16~ Week 56):
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-70 years old with mild to moderate essential hypertension;
- •Untreated patients (either newly diagnosed essential hypertension or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 2 weeks before the first visit) must have an office msSBP ≥ 150 mmHg and < 180 mmHg and DBP<110 mmHg;
- •Patients who had not received regular treatment with Amlodipine Besylate (5 mg/day) (less than 4 weeks of medication intake or a history of missing doses for 5 or more days within the 4 weeks before screening) with the mean sitting blood pressure of 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg;
- •Patients currently receiving other antihypertensive agents (non-study medications for at least 2 weeks prior to screening) with the mean sitting blood pressure of 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg, and the clinician determined that it was appropriate to switch to Amlodipine Besylate (5 mg/day);
- •Patients who have been stably treated with Amlodipine Besylate (5 mg/day) for at least 4 weeks with the mean sitting blood pressure of 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg. During randomization for the double-blind treatment period, mean sitting blood pressure should be 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg;
- •Participants enrolled in the ambulatory blood pressure monitoring (ABPM) study should have 24-hour mean ambulatory blood pressure ≥130/80 mmHg after 4 weeks of monotherapy treatment;
排除标准
- •Patients with secondary hypertension;
- •Patients with msSBP ≥180 mmHg and/or msDBP≥110 mmHg, or with hypertensive emergency or hypertensive urgency.
- •Patients with history of heart failure (New York Heart Association (NYHA) Functional Classification class III and IV), acute coronary syndrome, percutaneous coronary intervention, or other serious heart diseases (such as cardiogenic shock, moderate or severe heart valvular disorders, atrioventricular block second or third degree, bradycardia (with a heart rate <50 beats per minute), severe arrhythmias) in the past 6 months.
- •Patients with history of severe cerebrovascular diseases (such as hypertensive encephalopathy, cerebrovascular injury, stroke, transient ischemic attack) in the past 6 months.
- •Patients with aortic aneurysm, aortic dissection, or dissecting aneurysm.
- •Patients with renal artery stenosis or severe renal insufficiency (Cr>1.5 times the upper limit of normal).
- •Patients with blood potassium >5.5 mmol/L.
研究组 & 干预措施
Allisartan Isoproxil/Amlodipine group 1
Patients will be treated with one Allisartan Isoproxil/Amlodipine (240 mg/5 mg) tablet and one placebo of Amlodipine during the double-blind period (Week 4~Week 16) and one Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.
干预措施: Allisartan Isoproxil/Amlodipine group 1 (Drug)
Amlodipine group 1
Patients will be treated with one Amlodipine (5 mg) tablet and one placebo of Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the double-blind period (Week 4~Week 16) and one Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.
干预措施: Amlodipine group 1 (Drug)
Allisartan Isoproxil/Amlodipine group 2
Patients will be treated with one Allisartan Isoproxil/Amlodipine (240 mg/5 mg) tablet and one placebo of Allisartan Isoproxil tablet during the double-blind period (Week 4~Week 16) and one Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.
干预措施: Allisartan Isoproxil/Amlodipine group 2 (Drug)
Allisartan Isoproxil group 2
Patients will be treated with one Allisartan Isoproxil (240 mg) and one placebo of Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the double-blind period (Week 4~Week 16) and one Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.
干预措施: Allisartan Isoproxil group 2 (Drug)
结局指标
主要结局
Change from baseline in mean sitting systolic blood pressure after 12 weeks of randomized, double-blind treatment
时间窗: Baseline, week 12
Twenty-four hour mean msSBP will be performed at baseline and week 12 of double-blind treatment
次要结局
- Change from baseline in mean sitting diastolic blood pressure after 12 weeks of randomized, double-blind treatment(Baseline, week 12)
- The proportion of responders to antihypertensive treatment after 12 weeks of randomized, double-blind treatment(Week 12)
- Change from baseline in mean sitting systolic blood pressure and mean sitting diastolic blood pressure after 4 and 8 weeks of randomized, double-blind treatment(Baseline, week 4, week 8)
- The proportion of patients meeting the mean sitting blood pressure target after 4, 8, and 12 weeks of randomized, double-blind treatment(Week 4, week 8, week 12)