A Double-Blind, Randomized, Multicenter, Active-Comparative, 12-Week Study to Assess the Efficacy and Safety of the Drug in Conjunction With Another Drug in Korean Patients With Primary Hypercholesterolemia

Organon and Co0 个研究点目标入组 136 人开始时间: 2002年12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: 136
主要终点: LDL-C

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

Patients undergo 4-week placebo lead-in and diet period, and 12-week treatment period. Clinical efficacy and safety is evaluated at weeks 4, 8 and 12. This study takes approximately 18 weeks for an individual patient to complete including post-visit at week 14.

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

入选标准

•Korean males or females at least 18 years of age with hypercholesterolemia

排除标准

未提供

结局指标

主要结局

LDL-C

次要结局

TC, TG, HDL-C, Apolipoprotein A1, Apolipoprotein B, lipoprotein (a), LDL-C:HDL-C ratio, TC:HDL-C ratio

研究者

发起方

Organon and Co

申办方类型

Industry

责任方

Sponsor

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