EUCTR2009-012772-27-DK进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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 o product containing simvastatin 80 mg at Visit 1.
研究者
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