EUCTR2008-005002-40-HU进行中（未招募）不适用
A Randomized, Double-Blind, Active-Controlled, MulticenterStudy of Patients with Primary Hypercholesterolemia and HighCardiovascular Risk and not Adequately Controlled with Atorvastatin20 mg: A Comparison of Switching to a Combination TabletEzetimibe/Simvastatin (10mg/40mg) versus Doubling the BaselineDose to Atorvastatin 40 mg
适应症
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
- 240
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
- •* ATP III High Risk patients
- •* >=18 and <80 years of age with primary hypercholesterolemia.
- •* Either statin/ezetimibe naïve or on an acceptable stable dose, and willing to maintain a cholesterol-lowering diet for the duration of the study.
- •* Baseline LDL-C must be between = 100 mg/dL (2.59 mmol/L) and = 160 mg/dL (4.14 mmol/L), TG = 350 mg/dL (3.96 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 :
- •* hypersensitive/intolerant to any component of the study medication,
- •* has CHF NYHA Class III or IV,
- •* an uncontrolled hypertensive or diabetic, or is actively trying to lose weight.
- •* has estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
- •based on the 4-variable MDRD (Modification of Diet in Renal Disease) equation
- •at Visit 1 (as done by the central lab), nephrotic syndrome or other clinically
- •significant renal disease at Visit 1 (Week -6).
- •* has uncontrolled endocrine or metabolic disease known to influence serum
- •lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, e.g. hyper or
- •hypothyroidism, Cushing’s syndrome) at Visit 1 (Week -6).
- •* has uncontrolled cardiac arrhythmias or recent significant changes in the
- •patient’s electrocardiogram (ECG).
- •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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