A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Extended-Release (ER) Niacin and Laropiprant (ERN/LRPT) in Patients with Dyslipidemia

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 1,125 人开始时间: 2009年9月14日最近更新: 2012年6月12日

适应症

试验速览

暂无简介。

•1.Patient must meet one of the following criteria based on NCEP ATP III risk categorization:
•High risk (CHD or CHD risk equivalents, including diabetes and Framingham study 10-year risk of CHD >20%) on a statin with LDL-C <100 mg/dL (<2.59 mmol/L) or intolerant to statins with LDL-C <120 mg/dL (<3.11 mmol/L)
•Multiple risk (=2 risk factors and Framingham study 10-year risk of CHD =20%) with LDL-C <130 mg/dL (<3.37 mmol/L)
•Low risk (0-1 risk factors) with LDL-C <190 mg/dL (<4.92 mmol/L)
•2.Patient has TG levels <500 mg/dL (<5.65 mmol/L).
•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

•1.Patient has Type 1 or Type 2 diabetes mellitus and meets one or more of the following criteria:
•Patient is poorly controlled (HbA1C >8.5% at Visit 1)
•Patient is newly diagnosed (within 3 months of Visit 1)
•Patient has recently experienced repeated hypoglycemia or unstable glycemic control.
•Patient is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of ±10 units of insulin) within 3 months of Visit 1.
•2.Patient is currently taking or has taken niacin >50 mg once daily within 6 weeks of visit 1.
•3.Patient is taking a statin (or statin containing product) and fibrate concomitantly at Visit 1
•4.Patient is taking Aspirin greater than 100mg per day at Visit 1.
•Patient has chronic heart failure defined by the New York Heart Association (NYHA)
•Classes III or IV, uncontrolled cardiac arrhythmias, or poorly controlled hypertension
•(systolic blood pressure >160 mm Hg or diastolic >100 mm Hg)
•5. Patient has arterial bleeding
•6. Patient is chines and is on simvastatin 80 mg or a product containing simvastatin 80 mg at Visit 1

发起方