A Worldwide, Multicenter, Double-Blind, Parallel Study to Evaluate the Tolerability of MK0524A Versus Niacin Extended-Release

Merck Sharp & Dohme LLC0 个研究点目标入组 1,300 人开始时间: 2006年7月1日最近更新: 2017年2月16日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 1,300
主要终点: Global Flushing Severity Score (GFSS) over 16 weeks

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 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There will be 6 scheduled clinic visits and 2 treatment groups.

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

入选标准

•Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides < 500 mg/dL

排除标准

•Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) >/= 130 mg/dL and/or not on a statin
•Patients with diabetes and LDL-C >/= 130 mg/dL. Patients with >/= 2 heart disease risk factors and LDL-C >/= 160 mg/dL.
•Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.

结局指标

主要结局

Global Flushing Severity Score (GFSS) over 16 weeks

次要结局

Safety/tolerability

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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