A Randomized 8-week Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of LCZ696 200 mg in Comparison With Olmesartan 20 mg in Essential Hypertensive Patients Not Responsive to Olmesartan
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
- Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)
研究概览
简要总结
This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with mild to moderate hypertension, untreated or currently taking antihypertensive therapy
- •treated patients (using antihypertensive drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout epoch and after 4 weeks run-in epoch
- •untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and < 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and < 180 mmHg after 4 weeks run-in epoch
- •patients must successfully complete ABPM and pass technical requirements to be qualified for randomization
排除标准
- •Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
- •History of angioedema, drug-related or otherwise
- •History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease (PKD), drug-induced hypertension
- •Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment
研究组 & 干预措施
LCZ696 200 mg
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
干预措施: LCZ696 (Drug)
LCZ696 200 mg
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
干预措施: Placebo of LCZ696 (Drug)
Olmesartan 20 mg
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
干预措施: Olmesartan (Drug)
Olmesartan 20 mg
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
干预措施: Placebo of Olmesartan (Drug)
结局指标
主要结局
Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)
时间窗: baseline, 8 weeks
Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.
次要结局
- Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)(baseline, 8 weeks)
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)(baseline, 8 weeks)
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)(baseline, 8 weeks)
- Change From Baseline in Office Pulse Pressure(baseline, 8 weeks)
- Number of Patients Achieving Successful Overall Blood Pressure Control(8 weeks)
- Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control(8 weeks)
- Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response(baseline, 8 weeks)
- Number of Patients With Total Adverse Events, Serious Adverse Events and Death(8 weeks)
- Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control(8 weeks)
- Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response(baseline, 8 weeks)