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临床试验/EUCTR2009-015247-16-DE
EUCTR2009-015247-16-DE进行中（未招募）不适用

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 - SWITCH

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 1,508 人开始时间: 2010年7月28日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
1,508
研究概览入排标准研究者记录与标识符相似试验

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

  • •1. Men or women =18 and <80 years of age.
  • •2. Patient understands the study procedures, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
  • •3. Patient is at high cardiovascular risk (determined by a preliminary Cardiovascular Risk Assessment using historical lab values) and one of the following conditions are met:
  • •- Naïve to lipid-lowering therapy (or have been off such therapy for =6 weeks prior to Visit 1) and has a historical LDL-C value approximately within the range noted in the protocol*
  • •- Currently taking stable dose of a statin, ezetimibe, or statin + ezetimibe combination listed below with LDL-C lowering efficacy equivalent to or less than atorvastatin 10 mg and has a historical LDL-C value approximately within the range noted in the protocol.:*
  • •Simvastatin 10, 20 mg
  • •Pitavastatin 1 mg
  • •Atorvastatin 10 mg
  • •Pravastatin 10, 20, 40 mg
  • •Fluvastatin 20, 40, 80 mg
  • •Lovastatin 10, 20, 40 mg
  • •Ezetimibe 10 mg
  • •Ezetimibe 10 mg + Lovastatin 10 mg
  • •Ezetimibe 10 mg + Pravastatin 10 mg
  • •Ezetimibe 10 mg + Fluvastatin 20 mg
  • •4. Patient is willing to maintain an ESC / NCEP ATP III Therapeutic Lifestyle Changes(TLC) or similar cholesterol lowering diet for the duration of the study.
  • •5. A female patient who is of reproductive potential agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, condom, vasectomy, and non-cyclical hormonal
  • •contraception.*
  • •6. Female patients who are receiving non-cyclical hormone therapy (including noncyclical hormone replacement therapy or any estrogen antagonist/agonist, or noncyclical oral contraceptives) if maintained on a stable dose and regimen for at least 8 weeks prior to Visit 1 and if willing to continue the same regimen throughout the study.
  • •Patients will be eligible to continue to Visit 3 (Week -1) if they meet the following criteria:
  • •7. Patient has a naïve or on-treatment LDL-C value within the range noted in the protocol at Visit 2 (sample collected at Visit 1).
  • •8. Patient has liver transaminases (ALT and AST) =2xULN (sample collected at Visit 1) with no active liver disease at Visit 2.
  • •9. Patient has creatine kinase (CK) levels =3xULN at Visit 2 (sample collected at Visit 1).
  • •10. Patient has triglyceride (TG) concentrations =350 mg/dL (3.95 mmol/L) at Visit 2 (sample collected at Visit 1).
  • •11. Patient meets 2004 NCEP ATP III / 2006 AHA ACC updated guidelines and 2007 Fourth Joint European Societies recommendations for high risk. Risk criteria are determined by the Framingham calculation (using lipid values obtained at Visit 1)*
  • •- High-risk patients without cardiovascular disease (CVD)* including patients who have (1) diabetes, or (2) multiple risk factors and a 10-year risk for CHD >20% (as determined by the Framingham calculation)
  • •- High-risk patients with cardiovascular disease (CVD)* including patients with established coronary and other atherosclerotic vascular disease
  • •Patients will be eligible to continue to Visit 5 (Week 5) if they meet the following criteria:
  • •12. Patient has completed the 5 week atorvastatin 10 mg run-in period.
  • •13. Patient has at least 75% compliance with run-in medication during the active run-in period (determined by pill count) or, if patients are <75% compliance with run-in medication, they w

排除标准

  • •1. Patient is Asian.
  • •2. Patient has hypersensitivity or intolerance to ezetimibe, atorvastatin, rosuvastatin, or any component of these medications, or has a history of significant myopathy or rhabdomyolysis with ezetimibe or any statin.
  • •3. Patient routinely consumes more than 2 alcoholic drinks per day (average >14 alcoholic drinks per week). *
  • •4. Female patient who is pregnant or lactating.
  • •5. Patient has been treated with any other investigational drug within 30 days of Visit 1 (Week -6).
  • •6. Patient has any condition or situation which, in the opinion of the investigator, might have posed a risk to the patient or interfere with participation in the study.
  • •Prohibited Medical Conditions
  • •7. Patient has congestive heart failure defined by NYHA (New York Heart Association) Class III or IV.
  • •8. Patient has had a myocardial infarction, coronary artery bypass surgery, angioplasty, or acute coronary syndrome within 3 months prior to Visit 1.
  • •9. Patient has uncontrolled cardiac arrhythmias or recent significant changes in the patient’s electrocardiogram (ECG) as taken within 6 months prior to Visit 1.
  • •10. Patient has homozygous familial hypercholesterolemia or has undergone LDL-C apheresis.
  • •11. Patient has had a partial ileal bypass, gastric bypass, or other significant intestinal malabsorption.
  • •12. Patient has uncontrolled hypertension (treated or untreated) with systolic blood pressure >160 mmHg or diastolic >100 mmHg at Visit 2 (Week –5). Investigators are encouraged to maximize blood pressure control according to current guidelines.
  • •13. Patient 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).
  • •14. Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins at Visit 1 (Week -6).*
  • •15. Patient has disorders of the hematologic, digestive, or central nervous systems including cerebrovascular disease (e.g. stroke, TIA) and degenerative disease that would limit study evaluation or participation.
  • •16. Patient has poorly controlled Type I or II diabetes mellitus (HbA1c =8.5% at Visit 1 or newly diagnosed (within 3 months of Visit 1) and/or patient has recent history of repeated hypoglycemia or unstable glycemic control, or has had a change in treatment of antidiabetic pharmacotherapy or change of ±10 units of insulin, within 2 months of Visit 1 (Week -6).*
  • •17. Patient who is known HIV positive.*
  • •18. Patient has a history of malignancy =5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.*
  • •19. Patient has a history of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.
  • •Prohibited Therapies
  • •20. Patient is currently taking medications that are potent inhibitors of cytochrome P-450 3A4 (CYP3A4), including systemic azole antifungals (e.g., fluconazole, ketoconazole); erythromycin, clarithromycin or cyclosporine
  • •21. Patient is currently taking other medications that may increase the risk of myopathy, including the combinations of protease inhibitors.*
  • •22. Patient consumes > 5 cups (1.2 L) of grapefruit juice per day.
  • •23. Patient has

研究者

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