A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)
研究概览
简要总结
This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Renal findings: Hypertensive patients with renal dysfunction and stable renal condition at least 4 weeks before screening visit.
- •Satisfy office msSBP ≥140 mmHg and <180 mmHg at baseline.
排除标准
- •Patients show msDBP ≥110 mmHg and/or msSBP ≥180 mmHg.
- •History of angioedema, drug-related or otherwise, as reported by the patient.
- •Any other following renal disorder:
- •Patients show eGFR < 15mL/min/1.73m^2
- •Patients on dialysis
- •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 100 mg
All participants were started on LCZ696 100 mg once daily on day 1.
干预措施: LCZ696 (Drug)
LCZ696 200 mg
All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
干预措施: LCZ696 (Drug)
LCZ696 400 mg
All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
干预措施: LCZ696 (Drug)
结局指标
主要结局
Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)
时间窗: 8 weeks
Percentage of patients with total adverse events, serious adverse events and death were reported.
次要结局
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8(baseline, 8 weeks)
- Percentage of Participants Achieving DBP Control at Week 8(8 weeks)
- Percentage of Participants Achieving a Successful BP Control at Week 8(8 weeks)
- Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8(8 weeks)
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8(baseline, 8 weeks)
- Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8(8 weeks)
- Percentage of Participants Achieving SBP Control at Week 8(8 weeks)