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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Sancilio and Company, Inc.
Sponsor:
Information provided by (Responsible Party):
Sancilio and Company, Inc.
ClinicalTrials.gov Identifier:
NCT01997268
First received: November 22, 2013
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Severe Hypertriglyceridemia
Drug: Placebo
Drug: SC401B 2 capsules
Drug: SC401B 4 capsules
Drug: SC401B 6 capsules
Phase 3

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Sancilio and Company, Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 320
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997268

Contacts
Contact: Daren Graham 561-847-2302 ext 137 dgraham@sancilio.com
Contact: Thorstein Thorsteinsson, PhD 56-1847-2302 ext 144 TThorsteinsson@sancilio.com

Sponsors and Collaborators
Sancilio and Company, Inc.
Investigators
Principal Investigator: Kevin C Maki, PhD Biofortis Clinical Research
  More Information

No publications provided

Responsible Party: Sancilio and Company, Inc.
ClinicalTrials.gov Identifier: NCT01997268     History of Changes
Other Study ID Numbers: P-13-009
Study First Received: November 22, 2013
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sancilio and Company, Inc.:
Dyslipidemia
Hyperlipidemia
Omega-3 Fatty Acids
Metabolic Diseases
TG ≥500 mg/dL and ≤ 2,000 mg/dL

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014