Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST

Kos Pharmaceuticals0 个研究点开始时间: 2004年5月5日最近更新: 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

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 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).

详细描述

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

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

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 anti-dyslipidemic medications other than Zocor, he/she is willing to withdraw from these medications
•Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.
•LDL-C levels and/or Non HDL-C levels above normal for patients
•This study will be conducted both in the USA and internationally.

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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