Type 2b hyperlipidemia
Conditions
Interventions
Pitavastatin 2 mg daily for a period of 12 months
Bezafibrate 400 mg daily for a period of 12 months
Sponsors
The Research group for Arteriosclerosis treatment of The supporting Center for Clinical Research and Education : SCCRE, a nonprofit organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients whose LDL-cholesterol level is 140-179 mg/dL (If no measured values are available, values calculated by Friedewald's formula) and Triglyceride level is 150-399 mg/dL 2) Patients who have been diagnosed at least with one of following disease that a history of acute coronary syndrome, a history of cerebral infarction, arteriosclerosis obliterans, diabetes mellitus, and hypertension 3) Patients who are at age of 40 or over and less than 80 years at time of consent 4) Patients giving written consent by their own volition after being provided sufficient explanation for participation in this clinical trial
Exclusion criteria
Exclusion criteria: 1) Contraindication of Livalo Tab (pitavastatin calcium) - Patients with a history of hypersensitivity to any of the conponents of the product - Patients with severe hepatic disorder or biliary atresia - Patients receiving cyclosporine - Pregnant women, women suspected of being pregnant, or lactating women 2) Contraindication of Bezator SR tab (bezafibrate) - Patients with renal dialysis - Patients with significant renal disease like renal failure - Patients with serum creatinine >/= 2.0 mg/dL - Patients with history of hypersensitivity to any of the ingredients of the product - Pregnant women, women suspected of being pregnant, or lactating women 3) Patients with hepatic disorders (ALT or AST >/= 100IU/L) 4) Patients with HbA1c >/= 9.0% 5) Patients with obvious steonosis in carotid artery 6) Patients who are being treated with insulin 7) Patients whom the principle investigators or other investigators consider unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An absolute change of intima-media thickness (IMT) of common carotid artery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) A percent change of serum lipids and apolipoproteins (LDL-C, HDL-C, triglyceride, remnant lipoprotein-C, apoB48) 2) A percent change of serum lipoprotein fractionation 3) A percent change of high sensitive C-reactive protein (hs-CRP) 4) A percent change of adiponectin 5) Relationship between the absolute change in of intima-media thickness (IMT) of common carotid artery and percent change of each marker 6) Change in surface morphology and plaque tissue characterization | — |
Countries
Japan
Contacts
Public ContactShizuya Yamashita
Osaka University Graduate School of Medicine Department of Cardiovascular Medicine
Outcome results
None listed