A Worldwide, Multicenter, Double-Blind, Randomized, Parallel Study to Evaluate the Efficacy of MK-0524 to Improve Tolerability of Extended Release Niacin - Effect of an Investigational Compound on Tolerability of Extended Release Niacin

Merck & Co0 个研究点目标入组 825 人开始时间: 2006年7月3日最近更新: 2012年4月24日

适应症

试验速览

暂无简介。

•Patient is appropriate candidate for niacin therapy.
•Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C <130 mg/dL at V1.
•Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C <130 mg/dL at V1.
•Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C <160 mg/dL at V1.
•Patient has TG <500 mg/dL (5.65 mmol/L) at V1.
•A patient’s historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria.
•ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA.
•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

•Patients with unstable doses of medications.
•Pregnant or lactating women, or women intending to become pregannt are excluded.
•Patients with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin).
•Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year).

发起方

Merck & Co