EUCTR2007-002017-39-NL进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Parallel Group, 12-Week Study to Evaluate the Efficacy and Safety of Extended-Release (ER) Niacin/Laropiprant Added to Statin Versus Doubling the Dose of Statin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia. - Extended Release Niacin/Laropiprant – Lipids
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,250
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
入选标准
- •1. All patients must have their LDL-C value above their goal (based on NCEP ATP III Guidelines) when on a stable dose of statin defined by the protocol:
- •Patient is high risk (CHD/CHD risk equivalent including diabetes) with an LDL-C >100 mg/dL and =130 mg/dL (2.7 mmol/L and 3.4 mmol/L).
- •Patient has multiple risk factors (=2 RF) with an LDL-C >130 mg/dL and =160 mg/dL (3.4 mmol/L and 4.1 mmol/L).
- •Patient is low risk (0 to 1 RF) with an LDL-C >160 mg/dL and =190 mg/dL (4.1 mmol/L and 5.0 mmol/L).
- •2. Patient with diabetes mellitus must have a confirmed diagnosis and been on a stable dose of antidiabetic pharmacotherapy for 3 months prior to the study.
- •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 a history of hypersensitivity or allergic reaction to niacin or niacin-containing products, simvastatin, or atorvastatin.
- •2. Patient has uncontrolled/unstable cardiac arrhythmias, or unstable hypertension
- •3. Patient has taken torcetrapib alone or in combination and the last dose was within 1 year of Visit 1.
- •4. Patient has the following exclusionary laboratory values at Visit 1.
- •Creatinine >2.0 mg/dL (177 micromol/L)
- •ALT (SGPT) >1.5 x ULN
- •AST (SGOT) >1.5 x ULN
- •CK >2 x ULN
研究者
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