A Multicenter Study to Evaluate the Long-term Safety and Tolerability of Open-label LCZ696 in Patients With Acute Myocardial Infarction Who Previously Participated in CLCZ696G2301 (PARADISE-MI)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Number of participants with AE(s) leading to permanent study drug discontinuation, temporary study drug interruption, or study drug dose adjustment will be reported and summarized
研究概览
简要总结
The purpose of this study is to collect long-term safety and tolerability data of LCZ696 and to provide open-label LCZ696 to eligible participants who completed CLCZ696G2301 study (PARADISE-MI) if LCZ696 is shown to have a positive benefit-risk profile in comparison to ramipril in reducing risk of cardiovascular (CV) mortality and development of heart failure in participants enrolled in the PARADISE-MI study.
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
盲法说明
Open label
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 assessment is performed.
- •Participant received study treatment (either in LCZ696 or ramipril treatment arm) in PARADISE-MI.
- •Participant is safe to be enrolled in the extension study and may benefit from the treatment of LCZ696 per investigator's clinical judgement.
排除标准
- •Participant with a known history of angioedema
- •History of hypersensitivity to the study drug or drugs of similar chemical classes or known intolerance or contraindications to study drug or drugs of similar chemical classes including ACE inhibitors, ARB or NEP inhibitors
- •Symptomatic hypotension at screening
- •Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at screening
- •Known hepatic impairment (as evidenced by total bilirubin > 3.0 mg/dL or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices
- •Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LCZ696 (sacubitril/valsartan)
Following start of treatment, patients will receive LCZ696. Possible doses are level 1, 2, and 3 (50, 100 and 200 mg twice daily respectively)
干预措施: sacubitril/valsartan (Drug)
结局指标
主要结局
Number of participants with AE(s) leading to permanent study drug discontinuation, temporary study drug interruption, or study drug dose adjustment will be reported and summarized
时间窗: Up to 24 months
Adverse events (AEs) leading to treatment changes including treatment discontinuation, interruption, and dose adjustment
Number of participants with Serious Adverse Events (SAEs)
时间窗: Up to 24 months
SAE(s) will be reported, and the number of participants with SAE(s) will be summarized
Vital signs (Blood Pressure and pulse)
时间窗: Baseline and up to 24 months
BP and pulse will be measured at every visit. The test values of Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg) and heart rate (rate/minute) as well as change from the baseline will be summarized by parameter, using number of observations, mean, standard deviation, median, minimum, and maximum
次要结局
未报告次要终点