Patients with type IIb dyslipidemia and features of the metabolic syndrome.
Conditions
Interventions
Trade Name: Lipidil 145 ONE
Xafenor 145 mg Filmtablette
Elipsia 145 mg Filmtablette
Liperial 145 mg Filmtablette
Product Name: 145mg NanoCrystal® fenofibrate
Product Code: N/A
Pharmaceutical For
Sponsors
FOURNIER Laboratories Ireland Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 102 cm, women >88cm • HDL cholesterol: men =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate, in patients with type IIb dyslipidemia and features of the metabolic syndrome, the clinical advantage of 145mg NanoCrystal® fenofibrate over 10mg ezetimibe on plasma triglycerides (TG) and HDL-cholesterol (HDL-C) levels.;Secondary Objective: To compare the efficacy of 145mg NanoCrystal® fenofibrate, 10mg ezetimibe and combined therapy (145mg NanoCrystal® fenofibrate + 10mg ezetimibe) from baseline to 12 weeks treatment on Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Non HDL-Cholesterol, LDL size, Remnant Like Particles Cholesterol (RLP-C), Apo AI, Apo AII, Apo B, hs CRP, Fasting plasma Glucose and Insulin, HOMA-IR. To assess the safety of 145mg NanoCrystal® fenofibrate, 10mg ezetimibe and combined therapy after 12 weeks of treatment.;Primary end point(s): Percent change in TG and HDL-C from baseline to 12 weeks treatment between 145mg NanoCrystal® fenofibrate and 10mg ezetimibe. | — |
Countries
Germany
Outcome results
None listed