The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)

Sponsor

Sancilio and Company, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01997268

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Hypertriglyceridemia	Drug: Placebo Drug: SC401B 2 capsules Drug: SC401B 4 capsules Drug: SC401B 6 capsules	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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)

Actual Primary Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo 6 capsules (1.24 g each) daily for 12 weeks	Drug: Placebo Corn Oil
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

Outcome Measures

Primary Outcome Measures

Fasting Serum Triglycerides [12 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Be male or female, age 18 years
Have a TG level ≥500 mg/dL and ≤2,000 mg
Have the ability to understand the requirements of the study and be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions and return for the required assessments.
Be normally active and in good health on the basis of medical history.
Willing to maintain a stable diet and not alter their physical activity level throughout the study.
Women of childbearing potential must be willing to use accepted birth control methods throughout the study.

Exclusion Criteria:

Women who are pregnant, planning to become pregnant, or breastfeed during the study period
History of pancreatitis
Hemoglobin A1c > 9.5% (subjects with diabetes mellitus will be required to receive stable therapy)
History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary vascularization within 6 months before screening
Thyroid-stimulating hormone > 1.5 x upper limit of normal; clinical evidence of hypothyroidism or thyroid hormonal therapy that has not been stable for
6 weeks before screening
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x upper limit of normal
An unexplained creatine kinase concentration > 3 x upper limit of normal or creatine kinase elevation due to known muscle disease (e.g., polymyositis, mitochondrial dysfunction)
Blood donation of ≥1 pint within 30 days before screening or plasma donation within 7 days before screening
The consumption of >2 alcoholic beverages per day after screening; a history of illicit drug use within 1 year before screening
A history of symptomatic gallstone disease unless treated with cholecystectomy
Known nephrotic syndrome or >3 g/day proteinuria
Allergy or intolerance to omega-3 fatty acids, ethyl esters, or fish; known lipoprotein lipase impairment or deficiency or apoC-II deficiency or familial dysbetalipoproteinemia
History of cancer (other than basal cell carcinoma of the skin) in the past 2 years; and a history or evidence of major and clinically significant disease that could adversely affect the conduct of the study or patient safety.
Use acetylcholinesterase inhibitors or memantine, in the prior 2 months to screening
Use of a lipase inhibitor such as Xenical (orlistat)