NCT01256411已完成2 期
An Open-label, Long-term Extension Study to Evaluate the Safety, Tolerability and Efficacy of 12 Months of LCZ696 Treatment in Patients With Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 341
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)
研究概览
简要总结
The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study.
- •Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219.
排除标准
- •Patients who did not complete CLCZ696A
- •Presence of significant protocol violation in CLCZ696A
- •Patients who are deemed to be unable to comply with the protocol by the investigator.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LCZ696
Experimental
干预措施: LCZ696 (Drug)
LCZ696
Experimental
干预措施: Amlodipine (Drug)
LCZ696
Experimental
干预措施: Hydrochlorothiazide (HCTZ) (Drug)
结局指标
主要结局
Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)
时间窗: Baseline to 12 months
Participants were monitored throughout the study for adverse events, serious adverse events and deaths.
次要结局
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)(Baseline, 12 months)
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)(Baseline, 12 months)
- Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)(Baseline to 12 months)
- Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)(Baseline to 12 months)
研究者
研究点 (1)
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