The Hakodate multi-center pilot study of pitavastatin treatment on morphological changes of carotid atherosclerosis in patients with dyslipidemia

UMIN ID: UMIN000001479

Registered date:10/11/2008

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients with hypercholesterolemia
• Date of first enrollment: 2008/11/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): pitavastatin treatment

Outcome(s)

• Primary Outcome: Changes of IMT and LINE obtained by carotid ultrasonography at the 12 to 24 months from the baseline. Changes of PWV at the 12 to 24 months from the baseline.
• Secondary Outcome: Co-relation between morphological change of carotid artery and change serum lipids or inflammatory markers. Co-relation between Pulse Wave Velocity (PWV) and biomarkers.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients who meet contraindication or warning of LIVALO below(1-5). 1.Patients who have hypersensitivity to any component of this medicine. 2. Patients who have severe liver dysfunction or biliary atresia. 3. Patients receiving cyclosporine 4. Patients who are or might be pregnant or are in lactation period. 5. Patients taking fibrates with any abnormalities in clinical data about kidney function. 2) Patients already taking LIVALO. 3) Patients who are ineligible in the opinion of the investigator.

Related Information

• Primary Sponsor: Hakodate social gathering for atherosclerosis
• Source(s) of Monetary Support: Japan Heart Foundation