An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS)

Kos Pharmaceuticals0 个研究点目标入组 600 人开始时间: 2004年3月最近更新: 2006年11月1日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Kos Pharmaceuticals
入组人数: 600

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this 24 week study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS) in subjects with elevated fat levels in their blood (dyslipidemia).

At least 600 subjects with a similar medical condition will take part in this study.

详细描述

Objectives:

To evaluate the safety and efficacy of the combination product niacin ER and simvastatin (NS) in patients with primary type II dyslipidemia and to descriptively compare flushing rates between two Titration Schedules for NS.

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: None

入排标准

年龄范围: 21 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patient has primary Type II hyperlipidemia or mixed dyslipidemia.
•If the patient is currently taking a lipid modifying medication other than Zocor & he/she is willing to discontinue this medication
•LDL-C levels and/or non HDL-C levels above normal.
•Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.

排除标准

•Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives.
•HbA1c ≥ 9% in diabetic patients

研究者

发起方

Kos Pharmaceuticals

申办方类型

Industry

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