Trial record 10 of 194 for:
Open Studies | "Fatty Acids, Omega-3"
The Effect of Phytosterol Esters of Omega-3 (Vayarol) Versus Omega-3 Acids Ethyl Esters in Reducing Triglyceride Levels
This study is currently recruiting participants.
Verified September 2012 by Enzymotec
Sponsor:
Enzymotec
Collaborator:
Daewon Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Enzymotec
ClinicalTrials.gov Identifier:
NCT01712867
First received: October 18, 2012
Last updated: October 21, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Patients With Hypertriglyceridemia |
Other: Omega-3 acid ethyl esters Other: Phytosterol esters of omega-3 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Enzymotec:
Primary Outcome Measures:
- fasting triglycerides levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Noninferiority of phytosterol esters of omega-3 in affecting plasma fasting triglyceride levels in comparison with Omega-3 acids ethyl esters.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels
| Estimated Enrollment: | 206 |
| Study Start Date: | October 2012 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phytosterol esters of omega-3
4 capsules/day for 12 weeks
|
Other: Phytosterol esters of omega-3
4 capsules/day for 12 weeks
|
|
Active Comparator: Omega-3 acid ethyl esters
4 capsules/day for 12 weeks
|
Other: Omega-3 acid ethyl esters
4 capsules/day for 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female, age > 18 years
- Triglycerides ≥ 200 mg/dL and < 500 mg/dL
- Ability to give written informed consent
Exclusion Criteria:
- Female patient who are pregnant or breastfeeding or planning to become pregnant
- Fasting plasma glucose (FPG) levels > 110 mg/dL
- Type 2 diabetes mellitus that is poorly controlled (glycosylated hemoglobin [HbAlc ] >8.0%
- Patients who are under use of lipid altering drugs excluding use of Simvastatin, Atorvastatin, and Rosovastatin for 6 weeks or more
- Patients who are under use of products containing omega-3 fatty acids or other dietary supplements with potential lipid altering effects
- History of bariatric surgery or currently on weight loss drugs.
- Uncontrolled hypertension (BP>140/90)
- Subjects with secondary causes of hypertriglyceridemia: alcoholism, dysglobulinemia, thyroid disease that is poorly controlled (TSH<0.35 or TSH>5.5)
- Subjects with an abnormal level of liver enzymes (twice the normal level)
- Suffered from ischemic event such as myocardial infarction, cerebrovascular accident and angina pectoris in the last 6 months
- Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins such as cushing syndrome
- Gastrointestinal disease that may influence lipid metabolism such as celiac, crohn, colitis or other malabsorption problem
- 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.
- Consumption of one fish serving (200 grams) or sea food x2 a week or more.
- HIV infection by history
- History of hypersensitivity or allergy to fish, fish oil or soy
- BMI≥35
- Weight change > 3 kg during the run-in period
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712867
Locations
| Israel | |
| Maccabi Healthcare Services | Recruiting |
| Tel-Aviv, Israel | |
| Contact: Yossi Azuri, M.D 97235143738 Azuri_yo@mac.org.il | |
| Contact: Daphna Zaaroor-Regev, PhD 972747177155 Daphna@enzymotec.com | |
Sponsors and Collaborators
Enzymotec
Daewon Pharmaceutical Co., Ltd.
Investigators
| Principal Investigator: | Yossi Azuri, MD | Maccabi Healthcare Services, Israel |
More Information
No publications provided
| Responsible Party: | Enzymotec |
| ClinicalTrials.gov Identifier: | NCT01712867 History of Changes |
| Other Study ID Numbers: | Vayarol_006 |
| Study First Received: | October 18, 2012 |
| Last Updated: | October 21, 2012 |
| Health Authority: | Israel: Research Ethics Committee |
Additional relevant MeSH terms:
|
Hypertriglyceridemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013