A Multi-center, Randomized, Double-blind, Active-controlled, 8-week Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Patients With Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,438
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg
研究概览
简要总结
This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension
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 treatments within 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and <180 mmHg at the randomization visit (Visit 201) and msSBP≥140 mmHg <180 mmHg at the visit immediately preceding Visit 201 (Visit 102 or 103).
- •Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and <180 mmHg at both Visit 1 and Visit
- •Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and the immediately preceding visit.
排除标准
- •Patients with severe hypertension (msDBP ≥110 mmHg and or msSBP ≥180 mmHg).
- •History of angioedema, drug-related or otherwise, as reported by the patient.
- •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, and drug-induced hypertension.
- •Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
LCZ696 200 mg
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
干预措施: LCZ696 (Drug)
LCZ696 200 mg
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
干预措施: Placebo of LCZ696 (Drug)
LCZ696 200 mg
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
干预措施: Placebo of Olmesartan (Drug)
LCZ696 400 mg
Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
干预措施: LCZ696 (Drug)
LCZ696 400 mg
Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
干预措施: Placebo of LCZ696 (Drug)
LCZ696 400 mg
Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
干预措施: Placebo of Olmesartan (Drug)
Olmesartan 20 mg
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
干预措施: Olmesartan (Drug)
Olmesartan 20 mg
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
干预措施: Placebo of LCZ696 (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg
时间窗: baseline, 8 weeks
Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements.
次要结局
- Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability(baseline, 8 weeks)
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg(baseline, 8 weeks)
- Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.(baseline, 8 weeks)
- Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.(baseline, 8 weeks)
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg(baseline, 8 weeks)
- Number of Patients Achieving Successful Blood Pressure Control(8 weeks)
- Change From Baseline in Office Pulse Pressure (msPP)(baseline, 8 weeks)
- Change From Baseline in Mean 24-hour Ambulatory Blood Pressure(baseline, 8 weeks)
- Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.(baseline, 8 weeks)
- Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.(baseline, 8 weeks)
- Change From Baseline in Ambulatory Pulse Pressure(baseline, 8 weeks)
- Number of Responders(baseline, 8 weeks)