A Phase III Multicenter, Double-Blind, Crossover Design Study to Evaluate Lipid-Altering Efficacy and Safety of 1 g/10 mg Extended-Release Niacin/Laropiprant/Simvastatin Combination Tablets in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g /20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20 mg in reducing low-density lipoprotein cholestrol (LDL-C).

开始日期2011-05-01

申办/合作机构

Merck Sharp & Dohme Corp.

NCT01294683 / Terminated临床3期

A Phase III Multicenter, Double-Blind, Crossover Design Study to Evaluate Lipid-Altering Efficacy and Safety of Extended-Release Niacin/Laropiprant/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g/40 mg is equivalent to ERN/LRPT 2 g co-administered with simvastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C).

开始日期2011-02-04

申办/合作机构

Merck Sharp & Dohme Corp.

NCT00943124 / Completed临床1期

An Open-Label, Definitive Bioequivalence Study to Compare the Pharmacokinetics of the Simvastatin, Nicotinic Acid, and MK0524 (Laropiprant) Components of a Formulation of MK0524B With That of Zocor™ and MK0524A Tablets

This study will evaluate:
the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple combination tablet MK0524B.
the bioequivalence of laropiprant and ER niacin when administered as the triple combination tablet MK0524B or as the double combination tablet MK0524A given together with simvastatin.

开始日期2007-07-01

申办/合作机构

Merck Sharp & Dohme Corp.

100 项与拉罗匹仑/辛伐他汀/烟酸相关的临床结果

登录后查看更多信息

100 项与拉罗匹仑/辛伐他汀/烟酸相关的转化医学

登录后查看更多信息

100 项与拉罗匹仑/辛伐他汀/烟酸相关的专利（医药）

登录后查看更多信息

100 项与拉罗匹仑/辛伐他汀/烟酸相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
家族性混合型高脂血症	临床3期	-	Merck Sharp & Dohme Corp.	2007-06-15
原发性高胆固醇血症	临床3期	-	Merck Sharp & Dohme Corp.	2007-06-15
高脂血症	临床3期	美国	Merck GmbH	-
高脂血症	临床3期	亚洲	Merck GmbH	-
高脂血症	临床3期	澳大利亚	Merck GmbH	-
高脂血症	临床3期	欧洲	Merck GmbH	-
高脂血症	临床3期	墨西哥	Merck GmbH	-
高脂血症	临床3期	南美洲	Merck GmbH	-

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00289900 (MK-0524B-024 \| 0524B-024, CTgov)	临床3期	家族性混合型高脂血症	2,340	Simvastatin+MK-0524A (MK-0524B 2g/20 mg)	構觸繭鏇夢夢膚夢願繭(膚觸鹽獵窪簾窪獵餘鏇) = 壓鏇窪鏇繭網淵顧衊廠簾構繭糧範獵齋獵網顧 (鏇壓構鹽簾獵糧築窪築, 願獵糧鹽衊憲獵醖網鹹 ~ 鑰製鑰夢衊築淵餘艱網) 更多	-	2016-01-26
				Simvastatin+MK-0524A (MK-0524B 2g/40mg)	構觸繭鏇夢夢膚夢願繭(膚觸鹽獵窪簾窪獵餘鏇) = 簾鑰繭膚鏇鏇憲鹽範壓簾構繭糧範獵齋獵網顧 (鏇壓構鹽簾獵糧築窪築, 選築範齋選網顧鏇鏇廠 ~ 選淵窪選鏇淵遞壓願顧) 更多