Hypercholesterolemia
Conditions
Sponsors
Japan Atherosclerosis Regressive Treatment Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Hypercholesterolemia (LDL-C >= 140 mg/dL) (2) Patients with a max-IMT level of 1.1 mm or greater (3) Hospital stay or hospital visit: no object. (4) Patients who are able to submit written consent agreement by themselves.
Exclusion criteria
Exclusion criteria: (1) Patients that require lipid-lowering therapy other than the study drug or specified lipid-lowering drugs (anion-exchange resin, inhibitor of probucol, and ethyl icosapentate (EPA)) (2) Patients who have taken statins within one month before the start of the clinical trial. (3) Patients suspected of having serious carotid artery stenosis (greater than 80%) or having serious calcification. (4) Patients with familial hypercholesterolemia or secondary hypercholesterolemia. (5) Patients with fasting serum TG >= 400 mg/dL. (6) Patients with a history of sensitivity to statins. (7) Patients with uncontrolled hypertension. (8) Patients with Type I diabetes or uncontrolled Type II diabetes. (9) Patients who have experienced myocardial infarction or a cerebral stroke within 3 months or Patients with serious heart failure (NYHA class III to IV). (10) Patients with active hepatic disease. (11) Patients with renal disorder (Cr >= 2.0 mg/dL or Ccr < 30 mL/min/1.73m2). (12) Patients with CK > 500 IU/L. (13) Patients currently being treated with cyclosporine. (14) Patients that are pregnant or potentially pregnant, patients breast-feeding, or patients aiming to become pregnant during the clinical trial. (15) Patients with or suspected of having a malignant tumor, or patients with a history of malignant tumor except for the patients in whom recurrences have not been confirmed by routine observation after treatment. (16) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases. Patients with history of drug-related muscular disorder. (17) Patients with drug abuse or alcoholic. (18) Patients who are ineligible in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % change from baseline in mean-IMT at the end of 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Time to % change in mean-IMT. 2) Time to % change in max-IMT of the distal wall of the common carotid artery (IMT-Cmax-distal wall). 3) Time to % change in IMT-Cmax of common carotid artery, IMT-Bmax of carotid sinus, and IMT-Imax of internal carotid artery. 4) Percentage of cases in which mean-IMT decreased at the end of 12 months and 24 months. 5) Time to % change in LDL-C / HDL-C ratio. 6) Percentage of cases in which LDL-C / HDL-C ratio <= 1.5 at the end of 12 months and 24 months. 7) Percentage of cases in which LDL-C / HDL-C ratio <= 2.0 at the end of 12 months and 24 months. 8) Correlation between LDL-C / HDL-C ratio and max-IMT. 9) Correlation between LDL-C / HDL-C ratio and mean-IMT. 10) Time to % change of serum lipids (LDL-C, HDL-C, and TG), HbA1c, systolic blood pressure, and diastolic blood pressure. 11) JASGL2007 achievement ratio according to the management target level of LDL-C . 12) Cumulative incidence and content of cardiovascular and cerebral vascular events. | — |
Countries
Japan
Contacts
Public ContactToshifumi Kakutani
JART Study Support Center Mebix Inc.
Outcome results
None listed