Clinical research on concurrent therapy of Ezetimibe and Stati
Phase 4
Recruiting
- Conditions
- Coronary artery disease or diabetic
- Registration Number
- JPRN-UMIN000003168
- Lead Sponsor
- Tokushima Red Cross Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
(1)Patient that there is previous history of hypersensitivity in experimental drug or Statin (2)TG 400mg/dL or more (When the measurement of LDL-C is only a calculation method) (3)Patients with hepatic dysfunction (ALT>3 x upper limit of normal range) (4)Patients with renal dysfunction (Serum creatinine >2 x upper limit of normal range) (5)Patient of 9% or more in HbA1c (6)Patient of 1% or more in change of HbA1c (7)Patients with secondary hyperlipidemia or medicinal hyperlipemia (8)Patients with a history of CABG operation or stroke within recent 3 months (9)Pregnant or possibly pregnant women (10)Patients who are judged to be inappropriate as a subject by a doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of LDL-C
- Secondary Outcome Measures
Name Time Method 1)Accomplishment rate of less than LDL-C100mg/dL and accomplishment rate of less than LDL-C70mg/dL in patient with coronary artery disease. Or, the accomplishment rate of less than LDL-C value 120mg/dL in the diabetic. 2)Decreasing of hs-CRP. 3)Accomplishment rate of less than LDL-C70mg and less than hs-CRP0.2mg/dL in coronary artery disease person. 4)Change of HDL-C, LDL-C/HDL-C, nonHDL-C. 5)Electrocardiogram(improvement level of ST-T, ventricular rate, left ventricular hypertrophy (SV1+RV5)). 6)Change of kidney function(s-Cr, eGFR).