EUCTR2008-007689-52-LV进行中（未招募）1 期
A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients with Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled with Simvastatin 20 mg or Atorvastatin 10 mg: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin (10mg/20mg) Versus Switching to Rosuvastatin 10mg or Doubling the Statin Dose
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
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
入选标准
- •Patients with diabetes mellitus (Type 1 or 2) with cardiovascular disease, >=18 and <80 years of age with inadequately controlled lipids, either statin/ezetimibe naïve or on an acceptable stable dose, and willing to maintain a cholesterol-lowering and glucose-lowering diet for the duration of the study. Baseline LDL-C must be between = 70 mg/dL (1.81 mmol/L) and = 160 mg/dL (4.14 mmol/L), TG = 400 mg/dL (4.52 mmol/L), ALT/AST = 2.0 X ULN, and CK = 3.0 X ULN.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient is Asian, is hypersensitive/intolerant to any component of the study medication, has CHF NYHA Class III or IV, is an uncontrolled hypertensive or diabetic, or is actively trying to lose weight. Prohibited medications include CYP3A4 inhibitors, lipid-lowering agents, systemic corticosteroids, anti-obesity medications, warfarin, or medications that could increase the risk of myopathy.
研究者
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