Ezetimibe Together With Any Statin Cholesterol Enhancement

Organon and Co0 个研究点目标入组 1,496 人开始时间: 2004年6月最近更新: 2024年8月15日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Organon and Co
入组人数: 1,496
主要终点: Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months).

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

In patients with primary hypercholesterolemia treated with a statin and with ldl-c above the recommended target goal (esc 2003 recommendations ldl>=1.15 g/l) to compare the efficacy and the safety of ezetrol added to ongoing statin and non drug therapeutic intervention (patient motivation on diet or physical activities or both).

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 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Primary hypercholesterolemia treated with any statin at any dose, for at least 3 months with a ldl cholesterol above 115 mg/dl (esc 2003 recommendations).

排除标准

•pregnant or breast feeding women
•Lipid-lowering agents including hmg-coa reductase inhibitors other than the current statin, fish oils, cholestyramin, niacin (>200 mg/day) and fibrates taken within the 3 months preceding visit 1.

结局指标

主要结局

Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months).

次要结局

Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups.

研究者

发起方

Organon and Co

申办方类型

Industry

责任方

Sponsor

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