A Randomized, Double-blind, Crossover Study to Assess the Effects of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Cumulative Sodium Excretion (Natriuresis) at Day 1
研究概览
简要总结
This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Written informed consent must be obtained before any study assessment is performed.
- •Males and females of non-childbearing potential and of legal age (at least 18 years or older as defined by local law).
- •Asian patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy with up to two drugs.
排除标准
- •Women of child-bearing potential.
- •History of angioedema, drug-related or otherwise
- •History of hypersensitivity to LCZ696, valsartan, or drugs of similar chemical classes.
- •Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180 mmHg) at screening or at the end of the washout period.
- •History or evidence of a secondary form of hypertension,
- •Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
- •History of myocardial infarction, coronary bypass surgery or percutaneous coronary intervention (PCI) during 12 month prior to screening.
- •Current or history of hypertensive retinopathy.
- •Previous or current diagnosis of heart failure (NYHA Class II-IV).
- •Clinically significant valvular heart disease at screening.
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LCZ696 followed by Valsartan
Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
干预措施: Valsartan (Drug)
LCZ696 followed by Valsartan
Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
干预措施: LCZ696 (Drug)
Valsartan followed by LCZ696
Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks
干预措施: Valsartan (Drug)
Valsartan followed by LCZ696
Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks
干预措施: LCZ696 (Drug)
结局指标
主要结局
Cumulative Sodium Excretion (Natriuresis) at Day 1
时间窗: 0-6 and 0-24 hours on Day 1
Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 1
次要结局
- Cumulative Sodium Excretion (Natriuresis) at Day 28(0-6 and 0-24 hours on Day 28)
- Mean Sitting Pulse Pressure (PP) Over Time(Day-1, Day 14 and Day 28)
- Urine Volume (Diuresis) Over Time(Day -1, Day 1 & Day 28)
- Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time(Day-1, Day 14 and Day 28)