A Worldwide, Double-Blind, Randomized, Placebo-Controlled Study of MK0524A 2g Coadministered With Intensive LDL-C Lowering Therapy Compared to Intensive LDL-C Lowering Therapy Alone on Carotid Artery Intima Media Thickening (cIMT) in Patients With Heterozygous Familial Hypercholesterolemia (heFH)

Merck Sharp & Dohme LLC0 个研究点目标入组 937 人开始时间: 2006年9月最近更新: 2015年9月30日

适应症

试验速览

阶段: 3 期
状态: 终止
发起方: Merck Sharp & Dohme LLC
入组人数: 937
主要终点: Change in Mean Carotid Intima Media Thickness

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

This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima media thickening using ultrasound compared to patients taking placebo. There will be 12 scheduled clinic visits involving review of medical history, physical exam, vital signs, laboratory testing, ultrasound imaging, and electrocardiograms.

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 (Participant, Investigator)

入排标准

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

入选标准

•Patients who are 18 to 70 years of age with Heterozygous Familial Hypercholesterolemia and a LDL-C greater than or equal to 100mg/dL and triglycerides less than or equal to 400mg/dL at Visit 1 while on a stable dose of intensive LDL-C lowering therapy

排除标准

•A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
•Patients with less than 80% drug study compliance
•Patients with chronic medical conditions known to influence serum lipids or lipoproteins or significantly affect the ultrasound acoustic window
•Patients with unstable dose of medications
•Pregnant or lactating women, or women intending to become pregnant are excluded
•Patient with diabetes mellitus that is poorly controlled, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
•Patients with the following conditions: high grade stenosis (greater than 75%) of the carotid artery, chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, episode of gout (within 1 year)

结局指标

主要结局

Change in Mean Carotid Intima Media Thickness

时间窗: after 96 weeks of postrandomization treatment

change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.

次要结局

Change in Lipid Profile(after 96 weeks of postrandomization treatment)

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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