Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate or EPA in type 2 diabetic patients with hyperlipidemia.

UMIN ID: UMIN000000935

Registered date:01/09/2008

Basic Information

• Health condition(s) or Problem(s) studied: type 2 diabetic patients with hyperlipidemia
• Date of first enrollment: 2007/10/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Following a 8 weeks medication with rosuvastatin 2.5mg, subjects with not achieved NCEP ATPIII goal will be receive treatment with fenofibrate 200-201mg for 24 weeks.
Following a 8 weeks medication with rosuvastatin 2.5mg, subjects with not achieved NCEP ATPIII goal will be receive treatment with EPA 1800mg for 24 weeks.
Following a 8 weeks medication with fenofibrate 200-201mg, subjects with not achieved NCEP ATPIII goal will be receive treatment with rosuvastatin 2.5mg for 24 weeks.
Following a 8 weeks medication with EPA 1800mg, subjects with not achieved NCEP ATPIII goal will be receive treatment with rosuvastatin 2.5mg for 24 weeks.

Outcome(s)

• Primary Outcome: % change in TG, HDL-C and LDL-C at 24 weeks
• Secondary Outcome: Include assesment of ALT, SCr, CK(CPK) and at 24 weeks Change of the concentration of serum rosuvastatin at 24 weeks

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: The patient with liver or kidney disfunction or abnormality of CK

Related Information

• Primary Sponsor: Hiroshima University Hospital Department of Endoclinology
• Source(s) of Monetary Support: None