A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Patients With Severe Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths
研究概览
简要总结
This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive Japanese patients
详细描述
Summaries for treatment-emergent adverse events, serious adverse events and death were provided by the following actual treatment regimen (actual treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.
Summaries for others than above were provided by the following treatment regimen (determined by the maximal treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.
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
- •Satisfy office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at baseline
排除标准
- •Patients show msSBP ≥220 mmHg and/or msDBP ≥120 mmHg
- •History of angioedema, drug-related or otherwise, as reported by the patient
- •Patients unwilling or not able to discontinue safely the use of current antihypertensive medications during the study, as required by the protocol.
- •Patients have significant cardiovascular co-morbidities
- •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
All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
干预措施: LCZ696 (Drug)
LCZ696 400 mg
All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
干预措施: LCZ696 (Drug)
LCZ696 400 mg plus other hypertension (HTN) medications
All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
干预措施: LCZ696 (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths
时间窗: Week 8
Adverse events, serious adverse events deaths were monitored from screening to week 8.
次要结局
- Change From Baseline in msSBP and msDBP at Week 8(Baseline, 8 weeks)
- Percentage of Participants With SBP Response at End of Study(Baseline, 8 weeks)
- Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study(8 weeks)
- Percentage of Participants Achieving Successful msSBP Control at End of Study(8 weeks)
- Percentage of Participants Achieving Successful msDBP Control at End of Study(8 weeks)
- Percentage of Participants With DBP Response at End of Study(Baseline, 8 weeks)