Hypercholesterolemic patients with type 2 diabetes.
Conditions
Interventions
The add-on ezetimibe group (combined group) that received 2.5 mg/day of rosuvastatin and 10 mg/day of ezetimibe.
The rosuvastatin dose escalation group that received 5 mg/day of rosuvastatin.
Sponsors
First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects of this study are hypercholesterolemic patients with type 2 diabetes aged from 20 years to less than 80 years, who have been receiving rosuvastatin (2.5 mg/day) for more than 12 weeks but have LDL-C levels higher than 80 mg/dL, whose therapeutic regimen has not been changed for the past three months, and who have an HbA1c (NGSP) of less than 8.4%.
Exclusion criteria
Exclusion criteria: Patients with a history of familial hypercholesterolemia, patients who have developed stroke or ischemic heart disease within the past six months, patients with liver failure (ALT and/or AST >80 IU/L) or kidney failure (serum creatinine >1.3 mg/dL), patients using insulin, patients who are pregnant or could possibly become pregnant, and patients who are breast feeding are excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is set as the percent change of LDL-C after 12 weeks compared with baseline. | — |
Countries
Japan
Outcome results
None listed