Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-03 @ 7:59 PM
Study NCT ID:
NCT01997268
Status:
WITHDRAWN
Last Update Posted:
2016-11-25
First Post:
2013-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)
Sponsor:
Sancilio and Company, Inc.
Organization:
Study Overview
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)
Status:
WITHDRAWN
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never initiated. IND placed on Hold
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: