CTRI/2011/12/002216已完成4 期
Comparison of dose related effects of Atorvastatin on lowering of lipid levels in patients with dyslipidemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients >=18 years of age of either sex
- •2.Patients willing to give written informed consent.
- •3.Dyslipidemic patients eligible for lipid lowering therapy at baseline, as determined by NCEP-ATP III (National Cholesterol education program - Adult Treatment Panel III) guidelines.
- •< 2 risk factors for CHD, LDL >=160 mg/dL
- •>= 2 risk factors that confer a 10-year risk for CHD of <10%, LDL >=160 mg/dL
- •>=2 risk factors that confer a 10-year risk for CHD of 10% to 20%, LDL >=130 mg/dL
- •>=2 risk factors that confer a 10-year risk for CHD of >20%, LDL >=100 mg/dL
- •4. Patients willing to adhere to a low fat diet as advised by the study investigator
排除标准
- •1.Patients with history or clinical evidence of myocardial infarction, unstable angina, stable angina, coronary artery procedures (angioplasty or bypass surgery), or evidence of clinically significant myocardial ischemia.
- •2.Patients with history or clinical evidence of non-coronary forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease, transient ischemic attacks or stroke of carotid origin or 50% obstruction of carotid artery)
- •3.Patients with uncontrolled diabetes (i.e. fasting blood sugar > 140 mg/dL) or uncontrolled hypertension( diastolic blood pressure >95 mm Hg)
- •4.Impaired hepatic function (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >=2 Ã? the upper limit of normal [ULN])
- •5.Patients with current use of lipid lowering drugs (e.g., bile acid sequestrant, fibrate, nicotinic acid, fish oil), CYP 3A4 inhibitor (including cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, macrolide antibiotics) or oral corticosteroid
- •6.Intolerance to statins at any time in the past
- •7.Recent major surgery/illness/tissue injury/ muscle injury/ extensive burns
- •8.Family history or past history of muscular disorders
- •9.Excessive physical exercise of any form
- •10.Patients who have experienced any unexplained muscle pain, tenderness or weakness in the past
- •11.Decompensated hepatic / renal / GIT/ respiratory / haematological / infectious / metabolic / hormonal / autoimmune disorders
- •12.Pregnant / Lactating mothers and women of childbearing potential not using medically accepted methods of contraception.
- •13.Active alcohol intake
- •14.Drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance.
- •15. Participation in any clinical trial in the last 6 months
- •16.Any serious or unstable medical or psychological condition that in the opinion of the investigator would compromise the patients safety or successful participation in the trial for e.g. physical examination, laboratory test, ECG, e.t.c.
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