Prospective, randomized, open-label, clinical trial comparing the effects of pemafibrate and ethyl icosapentate on glucose/lipids metabolism and endothelial function in patients with hyperlipidemia
Not Applicable
Recruiting
- Conditions
- Hyperlipidemia
- Registration Number
- JPRN-UMIN000041139
- Lead Sponsor
- ational Defense Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Not provided
Exclusion Criteria
1) Allergy against pemafibrate/ethyl icosapentate 2) Poor-controlled diabetes (HbA1c>10.0 %) 3) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 4) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits 5) End stage renal failure 6) Symptomatic (NYHA III or IV) congestive heart failure 7) Malignancies or other diseases with poor prognosis 8) Pregnant 9) 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 Flow-mediated vasodilation in forearm Six weeks after administration
- Secondary Outcome Measures
Name Time Method Hemoglobin A1C levels, glycoalbumin levels, fasting blood glucose, lipids levels, HDL function, markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria/L-FABP) Six weeks after administration