EUCTR2020-002630-32-BE进行中（未招募）1 期
Dose response and safety of an oral PCSK9i, NNC0385-0434, in patients with established atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk on maximally tolerated statin dose and other lipid-lowering therapy requiring further LDL-C reduction
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 267
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
- •- Male patient or female patient of non-childbearing potential.
- •- Established atherosclerotic cardiovascular disease (ASCVD) (criteria a) or ASCVD risk (criteria b):
- •a)Age greater than or equal to 40 years at the time of signing informed consent and history of ASCVD
- •b)Age greater than 50 years at the time of signing informed consent and with ASCVD risk
- •- Serum LDL-C greater than or equal to1.8 mmol/L (greater than or equal to 70 mg/dL) as measured by the central laboratory at screening. Japanese patients: Serum LDL-C greater than or equal to 2.6 mmol/L (greater than or equal to 100 mg/dL) for patients of greater than or equal to 40 years of age and with a history of coronary heart disease, and serum LDL-C greater than or equal to 3.1 mmol/L (greater than or equal to 120 mg/dL) for all other Japanese patients
- •- Patients must be on maximally tolerated dose of statins.
- •- Patients not receiving statin must have documented evidence of intolerance to all doses of at least two different statins.
- •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 153
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 102
排除标准
- •- Treatment with PCSK9i therapy (alirocumab or evolocumab within 90 days prior to screening) or PCSK9 siRNA therapy (inclisiran within 12 months prior to screening).
- •- Fasting triglyceride greater than 4.52 mmol/L (greater than 400 mg/dL) as measured by the central laboratory at screening.
- •- Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- •- Renal impairment with eGFR below 30 ml/min/1.73 m^2 as measured by the central laboratory at screening.
研究者
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