A Multi-center, Randomized, Double-blind, Active-controlled, 8-week Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,161
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
研究概览
简要总结
This study assessed the efficacy of LCZ696 in Japanese 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 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 proceeding 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
- •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
LCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks
干预措施: LCZ696 (Drug)
LCZ696 200 mg
LCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks
干预措施: Placebo (Drug)
LCZ696 400 mg
LCZ696 200 mg tablet and a placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) once daily for one week; then up-titrated to LCZ696 400 mg and placebo to Olmesartan (1 capsule) once daily for the remaining 7 weeks
干预措施: LCZ696 (Drug)
LCZ696 400 mg
LCZ696 200 mg tablet and a placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) once daily for one week; then up-titrated to LCZ696 400 mg and placebo to Olmesartan (1 capsule) once daily for the remaining 7 weeks
干预措施: Placebo (Drug)
Olmesartan 20 mg
Olmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks
干预措施: Olmesartan (Drug)
Olmesartan 20 mg
Olmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
时间窗: Baseline, 8 weeks
Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.
次要结局
- Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8(Baseline, 8 weeks)
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)(Baseline, 8 weeks)
- Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8(8 weeks)
- Percentage of Participants Achieving a Successful msSBP Response(8 weeks)
- Change From Baseline in maSBP and maDBP for Daytime/Nighttime(Baseline, 8 weeks)
- Percentage of Participants Achieving a Successful msDBP Response(8 weeks)
- Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8(Baseline, 8 weeks)
- Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure(Baseline, 8 weeks)
- Number of Patients With Adverse Events, Serious Adverse Events and Death(8 weeks)
- Change From Baseline in Office Pulse Pressure(Baseline, 8 weeks)