EUCTR2011-005924-16-PL进行中（未招募）不适用
A 12-week, Double-blind, Randomized Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate /Simvastatin 145/20mg and Fenofibrate / Simvastatin 145/40mg Tablets vs. Matching Monotherapies in Dyslipidemic Subjects at High Risk of Cardiovascular Disease.
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
- 600
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.Either gender (tentatively 50% females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose of study medication). Accepted contraceptive methods are implants, injectables, combined oral contraceptives, intra-uterine device or sexual abstinence.
- •2.= 18 and < 80 years
- •3.With mixed dyslipidemia with fasting lipid results of a blood sample taken at inclusion and after at least 3 months of any statin monotherapy (excluding simvastatin 80 mg, atorvastatin 40 mg and 80 mg, rosuvastatin 20 mg and 40 mg):
- •?Triglycerides (TG) = 1.71 mmol/L (= 150 mg/dL) and
- •?Low-density lipoprotein cholesterol (LDL-C) = 1.81 mmol/L (= 70 mg/dL) but = 3.36 mmol/L (= 130 mg/dL)
- •4.High risk or very high risk based on known CVD or type 2 diabetes or type 1 diabetes with microalbuminuria or a SCORE chart risk = 5%
- •5.Aspartate aminotransferase and/or alanine aminotransferase = 2 times the Upper Normal of Limit (UNL)
- •6.Creatine kinase (CK) = 2 times the UNL (elevated CK may be randomized if associated with a clear history of trauma or severe exertion and documented by repeat measurement showing CK = 2 times the UNL)
- •7.Estimated Glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula = 60 ml/min/1.73m2
- •8.Thyroid-Stimulating Hormone (TSH) level excluding overt hypothyroidism or hyperthyroidism (in case of low TSH levels a free T4 test will be performed to exclude hyperthyroidism)
- •9.Subject must be willing to comply with the American Heart Association (AHA) Step I or similar diet recommended throughout the study
- •10.Having signed a written informed consent.
- •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 420
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •1.Known hypersensitivity to fibrates or simvastatin or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen or known allergic reactions caused by peanuts, peanuts or arachis oil or soy lecithin, or related products,
- •2.Pregnant or lactating women,
- •3.Unable or unwilling to comply with the protocol and the recommended diet,
- •4.Likely to withdraw from the study before its completion,
- •5.Having received an investigational drug or vaccine in the last 30 days before date of inclusion, or still participating in such a trial at Visit 1,
- •6.Associated diseases or conditions:
- •? Known active or chronic hepatobiliary or liver diseases (including biliary cirrhosis and unexplained persistent liver function abnormality e.g. persistent elevations in serum transaminases),
- •? Known cholelithiasis (except in case of cholecystectomy),
- •? Current chronic pancreatitis or identified risk or past history of acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia,
- •? Known current alcoholism or alcohol intake greater than 21 units per week,
- •? Medical history of myositis, myopathy or rhabdomyolysis,
- •? Known abnormal thyroid hormone levels (clinically euthyroid subjects on stable replacement doses of thyroid hormone are eligible for inclusion),
- •? Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins,
- •? Congestive heart failure NYHA Class III or IV (class III marked limitation of physical activity, class IV inability to carry out any physical activity without discomfort),
- •? Uncontrolled cardiac arrhythmias,
- •? Myocardial infarction, coronary bypass surgery or angioplasty within 3 months preceding inclusion in the study,
- •? Unstable or severe peripheral artery disease within 3 months preceding inclusion in the study,
- •? Unstable angina pectoris within 3 months preceding inclusion in the study,
- •? Any other severe pathology such as cancer or mental illness or degenerative disease that would limit study evaluation or participation,
- •? Known galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, fructose intolerance, or sucrase-isomaltase insufficiency.
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