A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Placebo After 8 Weeks Treatment in Patients With Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 389
- 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 is a phase 2 study in 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 must give written informed consent before any assessment is performed.
- •Patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmHg and < 110 mmHg, and mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg).
- •Patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment.
- •Patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance.
排除标准
- •Patients with severe hypertension.
- •Patients with history of angioedema, drug-related or otherwise
- •Pregnant or nursing women
- •Women of child-bearing potential , who do not use adequate birth control methods
- •History or evidence of a secondary form of hypertension.
- •History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, TIA, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease.
- •Diabetes mellitus.
- •Previous or current diagnosis of heart failure (NYHA Class II-IV).
- •Clinically significant valvular heart disease at the time of screening.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LCZ696 400 mg
LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
干预措施: Placebo (Drug)
LCZ696 100 mg
LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
干预措施: LCZ696 (Drug)
LCZ696 100 mg
LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
干预措施: Placebo (Drug)
LCZ696 200 mg
LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
干预措施: LCZ696 (Drug)
LCZ696 200 mg
LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
干预措施: Placebo (Drug)
LCZ696 400 mg
LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
干预措施: LCZ696 (Drug)
Placebo
Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
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, 8 weeks
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, 8 weeks)
- Change From Week 8 to Week 9 in msDBP and msSBP After Single-blind Placebo Withdrawal at Week 8(8 weeks, 9 weeks)
- Change From Baseline in 24 Hour Mean Ambulatory DBP and SBP(Baseline, 8 weeks)
- Change From Baseline in Daytime Mean Ambulatory DBP and SBP(Baseline, 8 weeks)
- Change From Baseline in Nighttime Mean Ambulatory DBP and SBP(Baseline, 8 weeks)
- Change From Baseline in Mean Sitting Pulse Pressure(Baseline, 8 weeks)
- Change From Baseline in Mean Ambulatory Pulse Pressure(Baseline, 8 weeks)
- Number of Participants Who Achieved a Successful Response in msDBP(8 weeks)
- Number of Participants Who Achieved a Successful Response in msSBP(8 weeks)
- Number of Participants Who Achieved Successful BP Control(8 weeks)
- Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP(baseline, 8 weeks)
- Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP(baseline, 8 weeks)