Hypertriglyceridemia With Low HDL-cholesterol
Conditions
Brief summary
The purpose of the study is to compare the efficacy and tolerability of fenofibrate 160 mg and niacin 1500 mg in patients with hypertriglyceridemia and low HDL-cholesterol. The primary end point is the percent change of apoB/A1 and the secondary end points are other lipid parameters and biomarkers.
Interventions
1\) fenofibrate 160 mg po for 16 weeks, 2) niacin 500 mg po for 4 weeks, niacin 1000 mg po for 4 weeks, niacin 1500 mg po for 8 weeks
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Triglyceride 150-500 mg/dL and HDL-cholesterol \< 45 mg/dL after 8 week dietary run in period * 20-79 years old
Exclusion criteria
* Low-density lipoprotein (LDL)-cholesterol ≥ 130 mg/dL without any lipid-modifying drug * History of cerebrovascular or cardiovascular diseases * Creatinine \> 2.0 mg/dL * Transaminase \> 2x upper limit of normal * Gall bladder disease * Cancer * Pregnant or breast feeding women * History of adverse events associated with test drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percent change of apoB/A1 | after 16 weeks of drug treatment |
Outcome results
None listed