A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Tolerability and Effect of MK0524A on Niacin-Induced Acute Flushing in Lipid Clinic Patients

Merck Sharp & Dohme LLC0 个研究点目标入组 330 人开始时间: 2007年4月1日最近更新: 2017年2月17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: 330
主要终点: MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme.

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

The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.

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: 否

入选标准

•Patient is male or female between 18 and 70 years of age
•Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study

排除标准

•Patient has a history of hypersensitivity to niacin or niacin-containing products
•Patient is currently experiencing menopausal hot flashes
•Patient consumes more than 2 alcoholic beverages per day
•Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
•Patient engages in vigorous exercise or an aggressive diet regimen

结局指标

主要结局

MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme.

时间窗: Over 1 week

次要结局

MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater).(Daily)

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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