Dislipidemiae (hypercholesteremia, hypertriglyceridemia or mixed forms) MedDRA version: 9.1 Level: LLT Classification code 10061227 Term: Lipid metabolism disorder
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rosuvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical Form: Film-coated tabl
Sponsors
Istituto Fisiologia Clinica, CNR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 20-80 years; 2) dislipidemiae; 3) cholesterol LDL > 120 mg/dl and/or 4) cholesterol HDL = 150 mg/dl; 6)in the absence of pharmacological therapy with statins and fibrates (or therapeutic wash-out for at least 3 months). Patients might also suffer from 1 or more of the following pathology: a)Modified fasting glycemia (fasting glycemia >= 110 mg/dl) following a dietetics and/or a stable pharmacological therapy (insulin and/or oral hypoglycaemic) for at least 6 months; b) arterial hypertension (>= 130/85 mmHg) under control, with diet or stable pharmacological treatment for at least 6 months; c) body overweight/obesity (BMI > 25 Kg/mq) and/or abdominal obesity: men waistline > 102 cm, women waistline > 88 cm, following a dietetic treatment; d) ischemic heart disease and/or multivessels atherosclerosis (as anamnestic data: previous angina/IMA) or proved by eco-doppler of neck vessels and/or abdominal aorta and/or peripheral vessels (absence of left ventricular dysfunction, EF > 50 %, proved by basal eco-cardiogram made within 6 months since the beginning of 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
Exclusion criteria
Exclusion criteria: 1) Acute or chronic heart failure (EF 2.5 times upper normal limit; 3) chronic renal failure (creatinine level >1.5 mg/dl and/or clearance of creatinine < 30 ml/h); 4) alcoholism; ; 5) neoplastic pathology previous and present; 6) systemic inflammatory pathology active; 7) myopathy or familiar history of hereditary muscular pathology; 8) pregnancy and/or nursing; 9) statins or fibrates treatment during the recruitment and/or during the 3 months preceding the beginning of the study; 10) statins or fibrates anamnestic intolerance or previous adverse effects with statins or fibrates use; 11) ciclosporin therapy during the recruitment; 12) glitazones and replaglinide therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the profile of GGT isoforms in patients with dislipidemiae.;Secondary Objective: 1) To assess the effect of lipid lowering treatment , in particular statins (rosuvastatin 10 mg, simvatatin 40 mg, atorvastatin 20 mg) or fibrates (gemfibrozil 900 mg), on GGT total and subfraction activity; 2) To find a novel effect of therapy with statins or fibrates, in addition to lipidic profile.;Primary end point(s): To assess the profile of GGT isoforms with FPLC methodology. | — |
Countries
Italy
Outcome results
None listed