PER-001-96已完成未知
A multicenter, double-blind, 16-week clinical trial comparing the efficacy and safety of atorvastatin (CI-981) once a day and simvastatin in patients with high LDL cholesterol.
PARKE DAVIS,0 个研究点目标入组 0 人开始时间: 1996年10月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 年龄范围
- 0 至 0（—）
入选标准
- •- LDL cholesterol value> 150mg/dL (>4.2mmol/L) and <250mg/dL (<6.5mml/L) in week -2 according to the Friedewald formula.
- •- Serum triglycerides <400mg/dL (<4.5mmol/L) measured in week -2.
排除标准
- •- Patients under 18 years old or over 80 years old.
- •- Pregnant women or in nursing.
- •- Patients consuming more than 14 alcoholic beverages per week (approximately 185g of pure alcohol).
- •- Documented hepatic dysfunction, and SGOT (AST) or SGPT (ALT) values>1.5 times the upper limit of the normal range.
- •- Secondary causes of hyperlipoproteinemia: uncontrolled primary hypothyroidism (TSH> 6.2UIU / mL), nephrotic syndrome, renal dysfunction, BUN> 30mg/dL (10.71mmol/L), creatinine>2.0mg/dL (176umol/L), uncontrolled noninsulin-dependent diabetes mellitus (HbA1c> 10%), diabetes mellitus type I, CPK>3 times the normal limit or unexplained CPK elevations.
- •- Body Mass Index> 32.
- •- Uncontrollable hypertension defined as a diastolic blood pressure >95mmHg after resting for a minimum of 3 minutes, whether or not taking antihypertensive medication.
- •- Patients who may be unreliable as research participants because of alcohol abuse or unwillingness/desire to adhere to a low-lipid diet.
- •- Patients who are participating in a concurrent clinical trial or who participated in a prior clinical trial 30 days before the enrollment in this study.
- •- Patients with known hypersensitivity to HMG-CoA inhibitors.
- •- Patients under medication excluded in Section 5.3.
- •- Patients who have suffered a myocardial infarction, coronary artery bypass surgery, angina pectoris or severe or unstable coronary angioplasty within three months prior to enrollment.
- •- Other conditions which according to investigator´s opinion may compromise the patient´s safety or their successful participation in this study.
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