A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia - 1 Year Open-Label Extension

Organon and Co0 个研究点目标入组 37 人开始时间: 2001年2月12日最近更新: 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: 37
主要终点: To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.

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 an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.

详细描述

The duration of treatment is 52 weeks.

研究设计

研究类型: Interventional
主要目的: Treatment

入排标准

年龄范围: 10 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with elevated sitosterol levels while taking current medication

排除标准

•Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

结局指标

主要结局

To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.

次要结局

Assess the percent change relative to baseline in LDL-C/plasma campesterol concentrations, and safety and tolerability after long-term treatment with MK0653 10 mg/day in patients with homozygous sitosterolemia

研究者

发起方

Organon and Co

申办方类型

Industry

责任方

Sponsor

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