EUCTR2007-000037-19-ES进行中（未招募）不适用
Estudio multicéntrico, aleatorizado, doble ciego, con grupos paralelos y de 12 semanas de duración para evaluar la eficacia y la seguridad de MK-0524B (en forma de MK-0524A administrado junto con simvastatina en comprimidos) en comparación con las de atorvastatina en pacientes con hiperlipidemia mixtaA Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluatethe Efficacy and Safety of MK-0524B (dosed as coadministered MK-0524A andSimvastatin Tablets) Versus Atorvastatin in Patients With Mixed Hyperlipidemia - MK-0524B Atorvastatin Comparator
Merck Sharp & Dohme de España S.A0 个研究点目标入组 2,335 人开始时间: 2008年6月18日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,335
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
- •Patient is male or female ?18 and ? 80 years of age on day of signing informed consent.
- •Patient meets one of the following criteria (based on NCEP ATP III categorization of CHD risk) at Visit 2 :
- •Following Washout of Previous Lipid-Lowering Therapy
- •Multiple Risk
- •Patient has been washed out of a statin or other lipid-modifying therapy and has multiple risk factors (?2 RF) with an LDL-C ?130 mg/dL and ?160 mg/dL (3.4 and 4.1 mmol/L).
- •Patient has been washed off of a statin or other lipid-modifying therapy and is low risk (0-1 RF) with an LDL-C ?130 mg/dL and ?190 mg/dL (3.4 and 5.0 mmol/L).
- •Naïve patients (not currently on lipid-lowering therapy)
- •Patient is not on a statin or other lipid-modifying therapy and is high risk (CHD/CHD risk equivalent including diabetes) with an LDL-C ?130 mg/dL and ?160 mg/dL (3.4 and 4.1 mmol/L).
- •Multiple Risk
- •Patient is not on a statin or other lipid-modifying therapy and has multiple risk factors (?2 RF) with an LDL-C ?130 mg/dL and ?160 mg/dL (3.4 and 4.1 mmol/L).
- •Patient is not on a statin or other lipid-modifying therapy and is low risk (0-1 RF) an LDL-C ?130 mg/dL and ?190 mg/dL (3.4 and 5.0 mmol/L).
- •Triglycerides (TG) concentrations ?150 mg/dL to ?500 mg/dL (1.7 - 5.6 mmol/L) at Visit 2.
- •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
- •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
- •?Abnormal TSH
- •Patient with Type 1 or Type 2 diabetes mellitus and:
- •?is poorly controlled (HbA1C at Screening >8%)
- •?is newly diagnosed (within 3 months of Visit 1)
- •?is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of ± 10 units of insulin) within 3 months of Visit 2.
- •?is taking lipid altering therapy which would require washout prior to study participation.
- •Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, such as hypothyroidism or hyperthyroidism).
- •Patient has a history of hypersensitivity or allergic reaction to niacin or niacin-containing Patient has history of myocardial infarction, stroke, coronary artery bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of Visit 1.products, simvastatin, or atorvastatin.
- •Patient is on lipid-modifying agents including fish oils >500 mg, bile-acid sequestrants, HMG-CoA reductase inhibitors, ezetimibe, ezetimibe/simvastatin, Cholestin? and other red rice yeast products within 6 weeks and fibrates within 8 weeks prior to Visit 2. Patients are eligible for participation in this study ONLY after the prespecified washout period as indicated.
- •Patient is a woman currently taking hormonal contraceptives or intermittent use of HRTs (e.g., estradiol, medroxyprogesterone, progesterone).
- •Patient is taking the following antioxidant vitamins:
- •Vitamin C in excess of 1500 mg/day
- •Vitamin E in excess of 45 IU/day for men, 36 IU for women
- •Beta Carotene 15000 IU for men 12000 IU/day for women
研究者
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