EUCTR2011-004130-34-DE进行中（未招募）不适用
A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 660
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
- •Patients with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2)
- •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 330
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 330
排除标准
- •Age < 18 or legal age of adulthood, whichever is greater.
- •Patients without established CHD or CHD risk equivalents.
- •LDL-C <70 mg/dL (<1.81 mmol/L) and patients with a history of documented cardiovascular disease.
- •LDL-C <100 mg/dL (<2.59 mmol/L) and patients without a history of documented CV disease.
- •Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L).
研究者
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