The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)
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.
Drug: SC401B 2 capsules
Drug: SC401B 4 capsules
Drug: SC401B 6 capsules
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled 12-Week Study to Determine the Efficacy of EPA+DHA (SC401B) on Hypertriglyceridemia (TG ≥ 500 mg/dL and ≤ 2000 mg/dL)|
- Fasting Serum Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment (12 weeks) in triglyceride levels between placebo and 2, 4, and 6 capsules per day of SC401B.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo 6 capsules (1.24 g each) daily for 12 weeks
Experimental: SC401B 2 capsules
SC401B 2 capsules (1.24 g each) + 4 placebo capsules daily for 12 weeks
|Drug: SC401B 2 capsules|
Experimental: SC401B 4 capsules
SC401B 4 capsules (1.24 g each) + 2 placebo capsules daily for 12 weeks
|Drug: SC401B 4 capsules|
Experimental: SC401B 6 capsules
SC401B 6 capsules (1.24 g each) daily for 12 weeks
|Drug: SC401B 6 capsules|
|Contact: Daren Graham||561-847-2302 ext firstname.lastname@example.org|
|Contact: Thorstein Thorsteinsson, PhD||56-1847-2302 ext 144||TThorsteinsson@sancilio.com|
|Principal Investigator:||Kevin C Maki, PhD||Biofortis Clinical Research|