JPRN-jRCT2080224897已完成3 期
A multicenter study to evaluate long-term safety and tolerability of open-label sacubitril/valsartan in pediatric patients with heart failure due to systemic left ventricle systolic dysfunction who have completed study CLCZ696B2319
ovartis Pharma. K.K.0 个研究点目标入组 240 人开始时间: 2019年9月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 13month old 至 <= 18age old（—）
- 性别
- All
入选标准
- •On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue
排除标准
- •- On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue
- •- Renal vascular hypertension (including renal artery stenosis)
- •- Significant renal estimated glomerular filtration rate disorder, hepatic disorder, gastrointestinal disorder or biliary disorder
- •- History of angioedema
研究者
相似试验
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CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failureEUCTR2018-004154-25-ESovartis Farmacéutica, S.A.240
进行中（未招募）
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CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failurePediatric heart failure : Patients (= 13 months) with HF due to systemic left ventricular systolic dysfunction. [Note: All patients per protocol for the core study CLCZ696B2319 (PANORAMA-HF) are to be <18 yrs at screening (enrollment). Patients will be 1 yr older when they are potentially eligible for entry in the OLE Study CLCZ696B2319E1]. Subjects who turned 18 yrs old during the PANORAMA-HF study, and who qualify, are eligible to participate in the OLE study. Ref section F.1.2MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849EUCTR2018-004154-25-FRovartis Pharma AG240
进行中（未招募）
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CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failureEUCTR2018-004154-25-BGovartis Pharma AG240
进行中（未招募）
1 期
CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failurePediatric heart failure : Patients (= 13 months) with HF due to systemic left ventricular systolic dysfunction. [Note: All patients per protocol for the core study CLCZ696B2319 (PANORAMA-HF) are to be <18 yrs at screening (enrollment). Patients will be 1 yr older when they are potentially eligible for entry in the OLE Study CLCZ696B2319E1]. Subjects who turned 18 yrs old during the PANORAMA-HF study, and who qualify, are eligible to participate in the OLE study. Ref section F.1.2MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849EUCTR2018-004154-25-HUovartis Pharma AG240
进行中（未招募）
1 期
CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failureEUCTR2018-004154-25-FIovartis Pharma AG240