A multicenter, double-blind, randomized study to compare the efficacy and safety of the combination of 145 mg fenofibrate and 40 mg simvastatin with 40 mg simvastatin monotherapy in patients with mixed dyslipidemia at risk of cardiovascular disease not adequately controlled by 40 mg simvastatin alone.

FOURNIER LABORATORIES IRELAND Ltd0 个研究点目标入组 1,945 人开始时间: 2007年1月11日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: FOURNIER LABORATORIES IRELAND Ltd
入组人数: 1,945

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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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
•2. >=18 and < 75 years
•3.Presenting with CHD or CHD risk equivalent per NCEP ATPIII (excluding diabetes) in whom 10-year risk for CHD is > 20%
•with no CHD but multiple >= 2 risk factors
•4.Having signed a written informed consent
•5.Patient must be willing to observe the AHA Step I or similar Diet recommended throughout the study.
•6.Presenting at inclusion (V1) with mixed (type IIb) dyslipidemia documented in the medical file and defined as follows on fasting lipid lab results:
•·For patients not treated with lipid lowering drugs at the time of blood sampling:
•-TG >= 2.28 mmol/L (>=200 mg/dL) and
•-TC >= 6.72 mmol/L (>= 260 mg/dL) or LDL-C >= 3.88 mmol/L ( >= 150 mg/dL) or non-HDL-C >=4.65 mmol/L ( >=180 mg/dL)
•·For patients treated with lipid lowering drugs at the time of blood sampling:-patients with CHD or CHD risk equivalent in whom 10-year risk for CHD is > 20%:
•-TG >= 1.71 mmol/L ( >=150 mg/dL) and
•-LDL-C >= 2.58 mmol/L ( >=100 mg/dL) or Non-HDL-C >= 3.36 mmol/L ( >= 130 mg/dL)
•-patients with multiple >= 2 risk factors:
•-TG >= 1.71 mmol/L ( >= 150 mg/dL) and
•-LDL-C >= 3.36 mmol/L ( >= 130 mg/dL) or non-HDL-C >= 4.13 mmol/L ( >= 160 mg/dL)
•If there are no fasting lipid lab results available in the patient's medical file at V1, a fasting lipid lab test must be performed in a local lab before entering the patient in the 40 mg simvastatin run-in phase and the results have to confirm the diagnosis of mixed dyslipidemia as defined above.
•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.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 oil and soy lecithin
•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 V1
•Associated diseases or conditions:
•6.Known type 1 or type 2 diabetes
•7.Known active or chronic hepatobiliary or liver diseases
•8.Known cholelithiasis (except in case of cholecystectomy)
•9.Current chronic pancreatitis or identified risk or past history of acute pancreatitis
•10.Known current alcoholism or alcohol intake greater than 21 units per week
•11.Medical history of myositis, myopathy or rhabdomyolysis
•12.Known abnormal thyroid hormone levels (clinically euthyroid patients on stable replacement doses of thyroid hormone are eligible for inclusion)
•13.Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
•14.Known renal failure or renal dysfunction
•15.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)16.Uncontrolled cardiac arrhythmias
•17.Myocardial infarction, coronary bypass surgery or angioplasty within 3 months of inclusion in the study
•18.Unstable or severe peripheral artery disease within 3 months of inclusion in the study
•19.Unstable angina pectoris within 3 months of inclusion in the study
•20.Any other severe pathology such as cancer or mental illness or degenerative disease that would limit study evaluation or participation
•Concomitant medications:
•For prohibited concomitant medication ongoing at V1 other than lipid-lowering drugs, treatment must be stopped, if clinically appropriate. If not clinically appropriate, the patient should not be included in the study.
•Treatment with lipid-lowering drugs other than fibrates must be stopped at least 4 weeks prior to baseline blood sample. Fibrates must be stopped at least 6 weeks prior to baseline blood sample.
•21.Treated with lipid-lowering drugs (statin, ezetimibe, fibrate, niacin…) other than simvastatin 40 mg. Patients receiving regular maintenance doses below 1g/day of OTC lipid-lowering medications (e.g. fish oils, omega-3 fatty acids supplements…) or OTC products (e.g. psyllium, fiber-based preparations and phytosterols) can be enrolled provided they are on stable dose for at least 4 weeks before randomization and agree to take the same preparation at an unchanged dose for the study duration.
•22.Treated with cyclosporin A, anti-vitamin K, long term systemic corticosteroids (unless the corticosteroids are for replacement therapy to treat pituitary adrenal disease and patients were treated with a stable regimen for at least 4 weeks before baseline blood sample),
•23.Treated with CYTP3A4 inhibitors or products with known drug interaction with simvastatin such as antifungal azoles (itraconazole, ketoconazole…), macrolide antibiotics (erythromycin, clarithromycin, telithromycin), HIV protease inhibitors (indinavir, ritonavir, saquinavir...) and delavirdine, verapamil, diltiazem, amiodarone and nefazodone,
•24.Change during the run-in period in medications that could interfere with th

研究者

发起方

FOURNIER LABORATORIES IRELAND Ltd

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3 期

A multicenter, double-blind, randomized study to compare the efficacy and safety of the combination of 145mg fenofibrate and simvastatin with 40mg simvastatin monotherapy in patients with mixed dyslipidemia at risk of cardiovascular disease not adequately controlled by 40 mg simvastatin alonePatients with mixed dyslipidemia with CHD or CHD risk equivalent or with multiple risk factor and a 10 year risk above or equal to 10% and with TG above 1.71mmol/l and LDL >2.58 or >3.36mmol/l according to risk after 6 weeks of treatment with 40mg simvastatin.Blood - Other blood disorders

ACTRN12605000777695Fournier Laboratories Ireland400