EUCTR2005-003270-14-HU进行中（未招募）不适用
A multicenter, double-blind, randomized, active comparator, forced-titration study to compare the efficacy and safety of the combination of 145 mg fenofibrate and 20 or 40 mg simvastatin with 40 mg simvastatin monotherapy in patients with mixed dyslipidemia at risk of cardiovascular disease not adequately controlled by 20 mg simvastatin alone - N/A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
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
- •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 (=
- •- 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 (=
- •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 20 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 first baseline blood sample. Fibrates must be stopped at least 6 weeks prior to first baseline blood sample.
- •21. Treated with lipid-lowering drugs (statin, ezetimibe, fibrate, niacin…) other than
- •simvastatin 20 mg. Patients receiving regular maintenance doses 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
- •first 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...), verapamil, diltiazem, amiodarone and nefazodone,
- •24. Change during the run-in period in medications that could interfere with the lipid
研究者
相似试验
进行中（未招募）
不适用
A multicenter, double-blind, randomized, active controlled study to compare the effect of long term treatment with LAF237 50 mg bid to gliclazide up to 320 mg daily in drug naïve patients with type 2 diabetesType II DiabetesEUCTR2004-000540-24-DEovartis Pharma Services AG800
撤回
3 期
A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability, and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX)10027665rheumatoid arthritisNL-OMON37109TEVA Pharma20
进行中（未招募）
不适用
A multicenter, double-blind, randomized, active controlled study to compare the effect of long term treatment with LAF237 50 mg bid to gliclazide up to 320 mg daily in drug naïve patients with type 2 diabetesType II DiabetesEUCTR2004-000540-24-DKovartis Pharma Services AG1,060
进行中（未招募）
不适用
A multicenter, double-blind, randomized, active controlled study to compare the effect of long term treatment with LAF237 50 mg bid to gliclazide up to 320 mg daily in drug naïve patients with type 2 diabetesType II DiabetesEUCTR2004-000540-24-GBovartis Pharma Services AG2,120
进行中（未招募）
不适用
A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2011-005021-48-BGTeva Pharmaceutical Industries544