EUCTR2004-002408-13-DE进行中（未招募）不适用
A randomised, double-blind study comparing the efficacy and safety of 145mg NanoCrystal® fenofibrate, 10mg ezetimibe and their combination in patients with type IIb dyslipidemia and features of the metabolic syndrome. - see protocol page 1
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
- 186
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
- •Patients will be selected for V1 based on the biological values (not older than 6 months) of LDL-C, HDL-C and TG in their medical files.
- •A patient will be eligible for study participation if he/she meets the following criteria at randomisation (V2):
- •1. Both genders, from 18 to 70 years old,
- •2. Presenting with type IIb dyslipidemia, as evidenced by:
- •LDL-C >or= 160 mg/dL (>or= 4.15 mmol/L)
- •TG >or= 150 mg/dL (>or= 1.7 mmol/L), and 3. In addition, they should have at least 2 of 4 following criteria, thus qualifying for the ATPIII/NCEP criteria for metabolic syndrome :
- •Waist circumference: men >102 cm, women >88cm
- •HDL cholesterol: men < 40 mg/dL (<1 mmol/L) and women <50 mg/dL (<1.3 mmol/L)
- •Blood pressure = 130 / = 85 mm Hg
- •Fasting glucose = 110 mg/dL (= 6.1 mmol/L)
- •4. With negative pregnancy test and a reliable method of contraception in female of
- •child bearing potential
- •5. Having signed a written informed consent at inclusion (V1)
- •6. Patient must be willing to observe the Step I Diet recommended by the NCEP throughout 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
- •A patient will be excluded from the study if he/she meets any of the following criteria at V2:
- •1. Known hypersensitivity to fibrates or ezetimibe or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen.
- •2. Women who are not surgically sterilized or not using adequate contraceptive precautions or not postmenopausal
- •3. Pregnant or lactating women
- •4. 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:
- •5. Type 1 or type 2 diabetes (fasting plasma glucose = 7 mmol/L)
- •6. Current chronic pancreatitis or identified risk or known history of acute pancreatitis
- •7. Known cholelithiasis in absence of cholecystectomy
- •8. Known gastric or peptic ulcer or intestinal disease within the previous 3 months of randomisation capable of modifying the intestinal absorption of the drugs
- •9. Significant hepatic disease: AST and/or ALT > 2 times the upper normal limit (UNL)
- •10. Acute alcohol intoxication, known alcoholism
- •11. Past medical history of myositis, myopathy or rhabdomyolysis
- •12. Musculoskeletal disease with increased Creatine phosphokinase (CK) > 3 times UNL
- •13. Renal failure or renal dysfunction defined by serum creatinine levels > 135 µmol/L in males and >110 µmol/L in females
- •14. Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level
- •15. Uncontrolled hypertension (SBP > 180 mm Hg and/or DBP > 110 mm Hg)
- •16. History of coronary heart disease (CHD), CHD-equivalent disease, or CHD risk >20% as defined by NCEP ATP III criteria
- •17. Any other severe pathology such as cancer, mental illness, chronic respiratory insufficiency, etc…, which in the opinion of the investigator might pose a risk to the patient or confound the results of the study
- •18. Treated with anti-diabetic drug(s), Cyclosporin A, anticoagulants, protease inhibitors
- •19. Treated within the last 4 to 6 weeks before randomisation with lipid lowering drug
- •20. Treated within the last 4 to 6 weeks before randomisation and/or surgery with weight lowering drugs
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