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

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

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000935

Enrollment

200

Registered

2008-09-01

Start date

2007-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetic patients with hyperlipidemia

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetic patients taking medication with rosuvastatin 2.5mg or fenofibrate 200-201mg or EPA 1800mg more than 8 weeks but not achieved NCEP ATPIII goals.

Exclusion criteria

Exclusion criteria: The patient with liver or kidney disfunction or abnormality of CK

Design outcomes

Primary

Measure	Time frame
% change in TG, HDL-C and LDL-C at 24 weeks	—

Secondary

Measure	Time frame
Include assesment of ALT, SCr, CK(CPK) and at 24 weeks Change of the concentration of serum rosuvastatin at 24 weeks	—

Countries

Japan

Contacts

Public ContactHiroshi Watanabe

Hiroshima University Hospital Department of Endoclinology

drhiroshi@hiroshima-u.ac.jp082-257-5196

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026