PER-001-97已完成未知
A multicentric, open-label, randomized, and parallel clinical trial to evaluate the efficacy of of Simvastatin and Atorvastatin for reducing LDL cholesterol in patients with hypercholesterolemia.
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 1997年6月19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
- •a. Coronary heart disease (CHD) and/or atherosclerotic disease (AD) with LDL>130 mg/dL (>3.4 mmol/L); or >2 risk factors for CHD without CHD and/or AD but LDL>160 mg/dL (>4.16 mmol/L); or without CHD and/or AD and <2 risk factors but LDL>190mg/dL (>4.9 mmol/L) at Visit 2 (Week -1).
- •b. Triglycerides >350mg/dL (>3.95 mmol/L) at Visit 2 (Week -1).
- •c. Liver transaminases (ALT, AST) with values not exceeding 10% of the normal upper limit (NUL) or CK values not exceeding 50% of the NUL without an obvious etiology in Visit 2 (Week -1).
- •d. Ages 21 to 70.
- •e. Alcohol consumption <10 drinks per week.
- •F. Men or women. Pre-menopausal women, unless they are surgically sterilized or have a high possibility of not conceiving. Highly Unlikely to conceive is defined as a woman who takes oral contraceptives or who have had an IUD for> 3 months without complaint.
排除标准
- •a. Type I, III, IV or V hyperlipidemia or familial hypercholesterolemia.
- •b. Treatment for lipid reduction including bile acid chelators, HMG-CoA reductase inhibitors and nicotinic acid (6 prior weeks) and fibrates (8 prior weeks), or probucol in a year period before selection (Visit 1, Week -4).
- •c. Any systemic immunosuppressant medication including cyclosporine; systemic azole antifungal agent including itraconazole and ketoconazole; erythromycin or clarithromycin; cisapride; H-1 blockers, terfenadine, astemizole, and nefazodone.
- •d. Therapy with warfarin or anticoagulants similar to warfarin.
- •e. Renal impairment defined by serum creatinine>1.8 mg/dL (>179pmol/L).
- •f. Active liver disease.
- •g. Acute coronary insufficiency (e.g., unstable angina or an intermediate syndrome); vasospastic angina (Prinzmetal).
- •h. Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary pacemaker surgery or infarction in the previous three months.
- •i. Uncontrolled hypertension (treated or not) with systolic blood pressure >160mmHg or diastolic >100 Hg.
- •j. Secondary hypercholesterolemia to hypothyroidism (T4 <4ug/dL and TSH>10ug/mL, measured at Visit 1, Week -4) or nephrotic syndrome.
- •k. Patients with Type 1 or Type 2 diabetes mellitus with HbA1c> 10% at Visit 1, Week -4.
- •I. Partial ileal anastomosis.
- •m. Weight 50% above the ideal body weight, according to the Metropolitan Tables of Weights and Heights of 1983.
- •n. Hypersensitivity to HMG-CoA reductase inhibitors.
- •o. Any other condition or therapy that, in the opinion of the investigator, may constitute a risk to the patient or may alter the results of the study.
- •p. Poor mental functions or any other reason for which the patient is believed to have problems to provide informed consent or to comply with the requirements demanded by the study.
- •q. Treatment with any other investigational medication within 30 days before the baseline.
研究者
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