Overview

This trial is active, not recruiting.

Condition patients with hypertriglyceridemia
Treatments omega-3 acid ethyl esters, phytosterol esters of omega-3
Phase phase 4
Sponsor Enzymotec
Collaborator Daewon Pharmaceutical Co., Ltd.
Start date October 2012
End date November 2014
Trial size 206 participants
Trial identifier NCT01712867, Vayarol_006

Summary

The primary objective is to determine the efficacy of phytosterol esters of omega-3 (Vayarol) versus Omega-3 acids ethyl esters in reducing triglyceride levels in hypertriglyceridemia patients with fasting triglyceride levels ≥ 200 and < 500 mg/dL.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
4 capsules/day for 12 weeks
phytosterol esters of omega-3
4 capsules/day for 12 weeks
(Active Comparator)
4 capsules/day for 12 weeks
omega-3 acid ethyl esters
4 capsules/day for 12 weeks

Primary Outcomes

Measure
fasting triglycerides levels
time frame: 12 weeks

Secondary Outcomes

Measure
Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Male or female, age > 18 years 2. Triglycerides ≥ 200 mg/dL and < 500 mg/dL 3. Ability to give written informed consent Exclusion Criteria: 1. Female patient who are pregnant or breastfeeding or planning to become pregnant 2. Fasting plasma glucose (FPG) levels > 110 mg/dL 3. Type 2 diabetes mellitus that is poorly controlled (glycosylated hemoglobin [HbAlc ] >8.0% 4. Patients who are under use of lipid altering drugs excluding use of Simvastatin, Atorvastatin, and Rosovastatin for 6 weeks or more 5. Patients who are under use of products containing omega-3 fatty acids or other dietary supplements with potential lipid altering effects 6. History of bariatric surgery or currently on weight loss drugs. 7. Uncontrolled hypertension (BP>140/90) 8. Subjects with secondary causes of hypertriglyceridemia: alcoholism, dysglobulinemia, thyroid disease that is poorly controlled (TSH<0.35 or TSH>5.5) 9. Subjects with an abnormal level of liver enzymes (twice the normal level) 10. Suffered from ischemic event such as myocardial infarction, cerebrovascular accident and angina pectoris in the last 6 months 11. Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins such as cushing syndrome 12. Gastrointestinal disease that may influence lipid metabolism such as celiac, crohn, colitis or other malabsorption problem 13. Subjects who have had any malignancy. Subjects who have had basal cell carcinoma that have been disease free for at least 3 years are eligible for the study. 14. Consumption of one fish serving (200 grams) or sea food x2 a week or more. 15. HIV infection by history 16. History of hypersensitivity or allergy to fish, fish oil or soy 17. BMI≥35 18. Weight change > 3 kg during the run-in period 19. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient

Additional Information

Official title The Effect of Phytosterol Esters of Omega-3 (Vayarol) Versus Omega-3 Acids Ethyl Esters in Reducing Triglyceride Levels in Hypertriglyceridemia Patients: A Double-blind, Randomized, Noninferiority Trial
Principal investigator Yossi Azuri, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Enzymotec.