A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Range Study to Evaluate the Efficacy and Safety of LCZ696 Comparatively to Valsartan, and to Evaluate AHU377 to Placebo After 8 Week Treatment in Patients With Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,334
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
研究概览
简要总结
This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.
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
- Double (Participant, Investigator)
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
- •Male or females from 18 up to and including 75 years
- •Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs)
- •Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2).
- •Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP> 95 mmHg at baseline (Visit 3);
排除标准
- •Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg)
- •History of angioedema, drug-related or otherwise, as reported by the patient
- •Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)
- •History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc.
- •History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease
研究组 & 干预措施
LCZ696 100 mg
Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: LCZ696 (Drug)
LCZ696 100 mg
Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: Placebo (Drug)
LCZ696 200 mg
Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: LCZ696 (Drug)
LCZ696 200 mg
Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: Placebo (Drug)
LCZ696 400 mg
Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: LCZ696 (Drug)
LCZ696 400 mg
Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: Placebo (Drug)
Valsartan 80 mg
Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: Valsartan (Drug)
Valsartan 80 mg
Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: Placebo (Drug)
Valsartan 160 mg
Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: Valsartan (Drug)
Valsartan 160 mg
Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: Placebo (Drug)
Valsartan 320 mg
Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: Valsartan (Drug)
Valsartan 320 mg
Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: Placebo (Drug)
AHU377 200 mg
Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
干预措施: AHU377 (Drug)
AHU377 200 mg
Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
干预措施: Placebo (Drug)
Placebo
Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: baseline, week 8
Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.
次要结局
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)(baseline, week 8)
- Change From Baseline in Nighttime maDBP and maSBP(baseline, 8 weeks)
- Percentage of Participants Who Achieved a Successful Response in msDBP(8 weeks)
- Percentage of Participants Who Achieved Successful Control in msSBP(8 weeks)
- Change From Baseline in Daytime maDBP and maSBP(baseline, 8 weeks)
- Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP(baseline, 8 weeks)
- Percentage of Participants Who Achieved Successful Control in msDBP(8 weeks)
- Percentage of Participants Who Achieved a Successful Response in msSBP(8 weeks)