Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone

Novartis1 个研究点分布在 1 个国家目标入组 83 人开始时间: 2003年8月1日最近更新: 2011年11月8日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 83
试验地点: 1
主要终点: Change from baseline in low density lipoprotein cholesterol after 12 weeks

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

The objective of this study is to assess the effect of the combination treatment on C-reactive protein and inflammatory markers as well as the safety and tolerability in a Spanish population

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: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients aged 18-75 Primary hypercholesterolemia Signed informed consent

排除标准

•Patients involved in clinical trials 3 months prior to inclusion Patients treated with drugs specified in protocol Fertile women not using contraceptive methods
•Other protocol defined in and exclusion criteria may apply

结局指标

主要结局

Change from baseline in low density lipoprotein cholesterol after 12 weeks

次要结局

Change from baseline in total triglyceride, high density lipoprotein cholesterol, and composition of low density lipoprotein cholesterol after 12 weeks
Change from baseline in circulating marker of inflammation after 12 weeks

研究者

发起方

Novartis

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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