Pitavastatin or bezafibrate intervention, assessment of antiarteriosclerotic effect (PIONEER)

Not Applicable

• Conditions: Type 2b hyperlipidemia

• Registration Number: JPRN-UMIN000001130
• Lead Sponsor: The Research group for Arteriosclerosis treatment of The supporting Center for Clinical Research and Education : SCCRE, a nonprofit organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-01
• Study Completion: 2012-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
An absolute change of intima-media thickness (IMT) of common carotid artery

Secondary Outcome Measures

Name	Time	Method
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