Carotid Atorvastatin Study In Hyperlipidemic Post-Menopausal Women: A Randomized Evaluation of Atorvastatin, Versus Placebo (CASHMERE)

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.70 个研究点分布在 3 个国家目标入组 400 人开始时间: 2003年1月1日最近更新: 2021年2月18日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 400
试验地点: 70
主要终点: Mean change in carotid IMT from baseline to month 12.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Postmenopausal women defined as having Age =< 70 years with documented menopause
•Fasting LDL cholesterol 130 mg/ dl (3.37 mmol/l)and =< 190 mg/ dl (4.92 mmol/l) after 6 weeks of diet
•Triglycerides =< 4 g/l(4.52 mmol/l)
•Informed, written consent

排除标准

•Age > 70 years
•Unconfirmed menopause
•Overall duration of treatment with any HMG-CoA Reductase inhibitor > 3 months within the last year
•Patient treated with any lipid-lowering drugs within the last 6 weeks preceding the randomization
•History of myocardial infarction, coronary bypass surgery, angioplasty, stroke or TIA
•CPK levels > 3 times upper limit of normal
•Body Mass Index >= 30

结局指标

主要结局

Mean change in carotid IMT from baseline to month 12.

次要结局

pulse wave velocity (PWV); Lipid profile
pulse pressure (PP); cross sectional distensibility and compliance (DC and CC)
Mean change from baseline to month 12 of carotid internal diameter (ID)
wall cross sectional area (WCSA); carotid arterial mass (AM)

研究者

发起方

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (70)

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