NCT05129241已完成不适用
Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector (MARS-NIS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Treatment acceptance assessed using the Injection Treatment Acceptance Questionnaire (ITAQ)
研究概览
简要总结
Primary objectives:
- To assess the effectiveness of the PRALUENT® 2 ml SYDNEY auto-injector as measured by the lipid-lowering effect of alirocumab after approx. 12 weeks treatment
- To assess the treatment satisfaction, as well as patient adherence and persistence after approximately 12 weeks of treatment with the PRALUENT® 2 ml SYDNEY auto-injector
Secondary objective:
Safety and tolerability
详细描述
Study duration per participant is approximately 12 weeks
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Primary hypercholesterolaemia (heterozygous familial or non-familial) or mixed dyslipidaemia AND confirmed vascular disease(*) AND other regular risk factors(**), OR confirmed familial heterozygous hypercholesterolaemia
- •Documented maximum dietary and drug lipid-lowering therapy within the last 12 months
- •Inadequate reduction of low-density lipoprotein cholesterol (LDL-C) despite maximum possible dietary and lipid-lowering therapy
- •The decision of the treating physician to use the PRALUENT® 2 ml SYDNEY auto-injector regardless of study enrolment
- •No previous therapy with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor OR prior treatment with a PCSK9 inhibitor every 2 weeks (Q2W) or monthly (Q4W)
- •Signed Informed Consent Form
- •(*) Coronary heart disease (CHD), cerebrovascular manifestation, peripheral arterial occlusive disease (PAOD)
- •(**) For cardiovascular events (e.g. diabetes mellitus, renal function glomerular filtration rate (GFR) < 60 ml/min)
排除标准
- •Planned or existing pregnancy, cancer, drug or alcohol abuse, dementia, or general inability to understand the content of the observational study
- •Existing treatment by lipid apheresis
- •Age < 18 years
- •Contraindications to treatment with alirocumab (PRALUENT®) according to the SmPC
- •Current participation in a clinical study
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Treatment acceptance assessed using the Injection Treatment Acceptance Questionnaire (ITAQ)
时间窗: week 12
Absolute change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)
时间窗: from baseline to week 12
Percent change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)
时间窗: from baseline to week 12
次要结局
- Number of patients with adverse events(up to 12 weeks)
- Number of quality defects assessed using product complaints(up to 12 weeks)
研究者
研究点 (1)
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