EUCTR2008-005002-40-LV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 II 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, 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
相似试验
进行中（未招募）
1 期
A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients with Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled with Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin - SWITCHPrimary HypercholesterolemiaMedDRA version: 12.1 Level: LLT Classification code 10020603 Term: HypercholesterolaemiaEUCTR2009-015247-16-FRMerck Sharp & Dohme Corp.1,508
进行中（未招募）
不适用
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 DoseEUCTR2008-007689-52-HUMerck & Co. Inc.800
进行中（未招募）
不适用
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 Doseipids not at goal in diabetic patients with cardiovascular diseaseEUCTR2008-007689-52-ATMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., N.J., USA800
进行中（未招募）
不适用
The study is to evaluate the effectiveness and safety of switching to coadministration ezetimibe and atorvastatin compared with doubling the dose of atorvastatin or switching to rosuvastatin in patients with primary hypercholesterolemia and high cardiovascular risk who are not adequately controlled with atorvastatin 10 mg. Ezetimibe, atorvastatin and rosuvastatin are each available by prescription to treat high blood cholesterol levels.EUCTR2009-015247-16-DKMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.1,508
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 mgPrimary hypercholesterolemiaMedDRA version: 9.1Level: LLTClassification code 10020604Term: HypercholesterolemiaEUCTR2008-005002-40-HUMerck & Co. Inc.240