ACTRN12606000377538已完成不适用
A comparison of the Effects of Vytorin (Ezetimibe and Simvastatin) versus Lipitor (Atorvastatin) in inducing changes to levels of novel serum biomarkers associated with Coronary Heart Disease risk.
Deartment of Epidemiology and Preventive Medicine CCRE in Therapeutics Monash University0 个研究点目标入组 550 人开始时间: 2006年8月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •Participation in the VYTUL study- Capable of and willing to sign written informed consent- Has been treated for at least the last 3 months with a daily dose of atorvastatin40 mg- Existing coronary heart disease and has cholesterol > 4.0 mmol/L measured at Visit 1 OR diabetes mellitus and has measured at Visit 1• cholesterol > 6.5 mmol/L OR• cholesterol > 5.5 mmol/L and HDL < 1 mmol/L- Free of any clinically significant diseases, other than hyperlipidaemia, that would interfere with study evaluations and willing and able to attend all study visits.
排除标准
- •Uncontrolled diabetes, defined by a measured HbA1c > 9% as measured at Visit 1-Has alanine aminotransferase (ALT) > 1.5 times Upper Limit of Normal (ULN) as measured at Visit 1- Has aspartate aminotransferase (AST) > 1.5 times ULN as measured at Visit 1-Has creatine kinase (CK) > 1.5 times ULN as measured at Visit 1- Has triglycerides (TG) > 4.5 mmol/L as measured at Visit 1- Has evidence of renal impairment with a serum creatinine > 200 µmol/L as measured at Visit 1- Has known drug or alcohol dependency within 6 months prior to Visit 1-A woman receiving hormonal therapy, including hormone replacement, anyestrogen antagonist/agonist, or oral contraceptives, who have not beenmaintained on a stable dose and regimen for at least 8 weeks and are willingto continue the same regimen for the duration of the study.- A woman of childbearing potential (includes women who are less than 1 yearpostmenopausal or not surgically sterile) not using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condomin combination with spermicide)- Women who are pregnant or breast feeding- Any condition or situation which, in the opinion of the investigator, might pose arisk to the subject or interfere with participation in the studyProhibited Medication for the Duration of the Study- Medications taken within 5 weeks prior to Visit 1 (Screening Visit) including: macrolide antibiotics, azole antifungals, fibric acid derivatives, niacin- Other medication as listed in the product information sheets for ezetimibe/simvastatin and atorvastatin.
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