EUCTR2020-003906-29-GR进行中（未招募）1 期
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)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Participant received study treatment (either in LCZ696 or ramipril treatment arm) in PARADISE-MI.
- •3. Participant is safe to be enrolled in the extension study and may benefit from the treatment of LCZ696 per investigator's clinical judgement.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 850
排除标准
- •1. Participant with a known history of angioedema
- •2. 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
- •3. Symptomatic hypotension at screening
- •4. Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at screening
- •5. 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
- •6. Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception
- •7. Other protocol-defined inclusion/exclusion criteria may apply
研究者
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