Prospective, randomized, open-label, clinical trial comparing fibrate monotherapy and fibrate-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, and markers for anti-inflammatory properties/obesity/antioxidative properties
Phase 4
- Conditions
- dyslipidemia
- Registration Number
- JPRN-UMIN000002964
- Lead Sponsor
- ational Defense Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) Allergy against ezetimibe 2) Under treatment with statins 3) Poor-controlled hypertension (DBP>110 mmHg) 4) Poor-controlled diabetes (HbA1c>10.0 %) 5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 6) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 7) Chronic renal failure (serum creatinine>2.0 mg/dl) 8) Malignancies or other diseases with poor prognosis 9) Pregnant 10) Subjects whose doctor in charge do not agree to join the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6/12/24 months after randomization Flow-mediated vasodilation in forearm, 6 months after randomization Heparin-releasable EC-SOD levels, 6 months after randomization
- Secondary Outcome Measures
Name Time Method Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6/12/24 months after randomization