Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01997268
Recruitment Status : Withdrawn (Study never initiated. IND placed on Hold)
First Posted : November 28, 2013
Last Update Posted : November 25, 2016
Information provided by (Responsible Party):
Sancilio and Company, Inc.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : December 2014

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

Primary Outcome Measures :
  1. Fasting Serum Triglycerides [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01997268

Sponsors and Collaborators
Sancilio and Company, Inc.
Layout table for investigator information
Principal Investigator: Kevin C Maki, PhD Biofortis Clinical Research, Inc.
Layout table for additonal information
Responsible Party: Sancilio and Company, Inc. Identifier: NCT01997268    
Other Study ID Numbers: P-13-009
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Keywords provided by Sancilio and Company, Inc.:
Omega-3 Fatty Acids
Metabolic Diseases
TG ≥500 mg/dL and ≤ 2,000 mg/dL
Additional relevant MeSH terms:
Layout table for MeSH terms
Lipid Metabolism Disorders
Metabolic Diseases