Recognized Effect of Statin and Ezetimibe therapy for achievement LDL-C Goal
Not Applicable
- Conditions
- type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000002593
- Lead Sponsor
- Clinical study group for diabetes and dyslipidemia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
(1) History of hypersensitivity to atorvastatin, pitavastatin or ezetimibe (2) Serum triglyceride level more than 400mg/dl (3) Hepatic dysfunction (an alanine aminotransferase level that is more than twice the upper limit of the normal range) (4) Uncontrolled diabetes (HbA1c more than 9.0%) (5) Renal dysfunction (a creatinine level that is higher than 2.0 mg per deciliter) (6) Secondary or drug-induced hypercholesterolemia (7) Homozygous familial hypercholesterolemia (8) Pregnant or nursing women or women suspect of pregnancy (9) Judged as inappropriate for study by doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent reduction in LDL-C from baseline to study endpoint.
- Secondary Outcome Measures
Name Time Method Percentage of patients who reached the treatment goals (LDL-C 120mg/dl or 100mg/dl). Percent change of serum lipids, serum markers of glucose metabolism and serum markers of inflammation.