A Multicenter, Randomized, Double-Blind, Crossover” Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet Compared to MK 0524A + Simvastatin Coadministration in Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia.

aboratoires Merck Sharp & Dohme-Chibret0 个研究点目标入组 2,370 人开始时间: 2007年6月20日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•Patient is male or female =18 and =85 years of age on day of signing informed consent.
•Patient has primary hypercholesterolemia or mixed dyslipidemia based on medical history (previous diagnosis), historic lipid values (within 6 months of screening), or as otherwise determined by the investigator through optional lipid measurements at screening visit (Visit 1 or prior to washout period).
•Patient meets one of the following triglyceride (TG) criteria:
•a.Patient is on niacin, statin, or fibrate and has TG <500 mg/dL (5.65 mmol/L) at or within 6 months of washout (Pre-screen visit).
•b.Patient is not on any lipid-modifying therapy or is on lipid-modifying therapy other than niacin, statin, or fibrate and has TG <600 mg/dL (6.78 mmol/L) at or within 6 months of screening (Visit 1 for naïve patients or Prescreen visit for washout patients).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patient is high risk (CHD or CHD risk equivalent based on NCEP ATP III) AND is on a statin. Note: High risk patients not currently being treated with a statin are eligible
•Patient is on a statin dose with equivalent or greater LDL-C-lowering efficacy than that of simvastatin 80 mg.

发起方

aboratoires Merck Sharp & Dohme-Chibret