The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to investigate the effects of SC401B (ethyl esters of
eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] 2 (~1260 mg EPA+DHA), 4 (~2520 mg
EPA+DHA) or 6 (~3780 mg EPA+DHA) capsules per day in subjects with hypertriglyceridemia
(triglyceride [TG] ≥500 mg/dL and ≤ 2,000 mg/dL). SC401B capsules also contain certain
surfactants that may aid in the absorption of EPA and DHA. Based on the results of
pharmacokinetic studies of healthy human subjects, unlike Lovaza®, EPA and DHA in SC401B are
bioavailable in both the fasted and fed states.
The protocol specified primary endpoint is the difference from the placebo group in the
percent change in TG concentration from baseline to week 12 for groups receiving 2, 4, or 6
capsules of SC401B per day. The protocol specified secondary endpoints include percent
changes from baseline to week 12 for total cholesterol (TC), LDL-cholesterol (LDL-C),
HDL-cholesterol (HDL-C), and non-HDL-cholesterol (non-HDL-C). Additional exploratory
variables include VLDL-cholesterol (VLDL-C), LDL-cholesterol particle size, apolipoprotein
(Apo) A1, Apo B, Apo C-III, and lipoprotein-associated phospholipase A2 (Lp-PLA2).
An additional objective is to determine the tolerability and safety of SC401B 2, 4 and 6
capsules per day for 12 weeks. Adverse events for SC401B and placebo including burping, fishy
taste, upset stomach, loose stools, stools with fishy smell or any other self-reported
observations will be evaluated. Additional safety measures will include changes in liver
enzymes (AST/ALT) occurring from baseline to week 12 for groups receiving 2, 4, and 6
capsules of SC401B and placebo.