A 14 Week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 588
- 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
The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of 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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must give written informed consent before any assessment is performed
- •Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and < 180 mmHg
- •Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance
- •Exclusion criteria:
- •Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients with history of angioedema, drug-related or otherwise
- •Patients with history or evidence of a secondary form of hypertension
- •Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke
- •History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit
- •Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).
- •Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication
- •Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).
- •Patients with a clinically significant valvular heart disease at the time of screening
- •Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
LCZ696
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
干预措施: Placebo (Drug)
LCZ696
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
干预措施: LCZ696 (Drug)
Olmesartan
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
干预措施: Olmesartan (Drug)
Olmesartan
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
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, 10 weeks
Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.
次要结局
- Change From Baseline in Daytime and Nighttime maSBP/maDBP(Baseline, 10 weeks)
- Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers(Baseline, 10 weeks)
- Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers(Baseline, 10 weeks)
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)(Baseline, 4 weeks, 14 weeks)
- Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)(Baseline, 10 weeks)
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)(Baseline, 10 weeks)
- Change From Baseline in Mean Sitting Pulse Pressure(Baseline, 4 weeks, 10 weeks, 14 weeks)
- Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)(4 weeks, 10 weeks, 14 weeks)
- Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)(Baseline, 10 weeks)
- Number of Participants Achieving Successful Response in msSBP and msDBP(4 weeks,10 weeks, 14 weeks)
- Number of Participants With Adverse Events, Serious Adverse Events and Death(14 weeks)