Dyslipidaemia MedDRA version: 5.1 Level: LLT Classification code 10058108
Conditions
Interventions
Trade Name: Locol 80 mg Retardtabletten
Product Name: Locol 80 mg Retardtabletten
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Fluvastatin
CAS Number: 93957-55-2
Current Sponsor
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent to participate in the study prior to any study procedures. 2. Male or female subjects, age between 18-75 years inclusive. 3. All women of child bearing potential must have a negative pregnancy test 4. Metabolic Syndrome according to the IDF definition: a) Low plasma HDL-C (Men =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with homozygous familial hypercholesterolemia, and Fredrickson Types I, IV and V dyslipoproteinemia. 2. Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease etc. 3. Type 1 diabetes or secondary type 2 diabetes such as cushing syndrome 4. Lipid-lowering agents: A 6-week wash out period from HMG-CoA reductase inhibitors, fibrate derivatives, niacin and anti-obesity drugs is required. Patients treated with probucol should have discontinued it for at least one year. 5. Triglyceride levels > 1000 mg/dL (11.28 mmol/L) at week -1. 6. FPG > 270 mg/dL (15 mmol/L) at week -1. 7. HbA1c > 9.5% at week -1. 8. ALT/SGPT and/or AST/SGOT > 2 x ULN at Visit 2/Week -1. 9. Impaired renal function with a serum creatinine > 2 x ULN at Visit 2/Week -1. 10. Unexplained serum CPK levels >2 x ULN at Visit 2/Week -1. 11. History of dialysis or of nephrotic syndrome. 12. History or evidence of muscular or neuromuscular disease. 13. Malignant or poorly controlled hypertension (SBP>160mmHg, DBP >100mmHg). 14. History of severe cardiovascular disease (myocardial infarction, bypass surgery, coronary angioplasty, cerebral stroke, unstable angina pectoris). 15. History of heart failure (e.g., New York Heart Association Class II and above). 16. Any surgical or medical conditions which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period. Further exclusion criteria are defined in the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare the effects of the combination of fluvastatin 80 mg ER and fenofibrate 200 mg to the combination of simvastatin 20 mg and ezetimibe 10 mg on the following parameters 1. Number of patients reaching target levels of LDL-C <100mg/dl 2. Number of patients reaching target levels of non-HDL-C <130mg/dl 3. LDL-C/HDL-C 4. Apolipoprotein A-I 5. Triglycerides 6. Total cholesterol 7. LDL subfractions in a subgroup of patients 8. Endothelial function in a subgroup of patients 9. Liver enzymes and CPK levels;Main Objective: To confirm that the combination of fluvastatin 80 mg extended release (ER) and fenofibrate 200 mg has superior efficacy in increasing HDL-C compared with the combination of simvastatin 20 mg and ezetimibe 10 mg after a treatment period of 6 weeks each in patients with type 2 diabetes/metabolic syndrome;Primary end point(s): The primary parameter of the study will be HDL-C measured at the end of each study period. | — |
Countries
Germany
Outcome results
None listed