Patients With HypertriglyceridemiaNCT01712867
The Effect of Phytosterol Esters of Omega-3 (Vayarol) Versus Omega-3 Acids Ethyl Esters in Reducing Triglyceride Levels
A study testing Omega-3 acid ethyl esters and Phytosterol esters of omega-3 in people with Patients With Hypertriglyceridemia, run by Enzymotec at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Hypertriglyceridemia
- What is being tested?
- Omega-3 acid ethyl esters and Phytosterol esters of omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age > 18 years
- Triglycerides ≥ 200 mg/dL and < 500 mg/dL
- Ability to give written informed consent
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Patients With Hypertriglyceridemia
- Being tested
- Omega-3 acid ethyl esters, Phytosterol esters of omega-3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 acid ethyl estersOther
4 capsules/day for 12 weeks
Phytosterol esters of omega-3Other
4 capsules/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Phytosterol esters of omega-3 | Experimental | 4 capsules/day for 12 weeks Receives: Other: Phytosterol esters of omega-3 |
| Omega-3 acid ethyl esters | Active comparator | 4 capsules/day for 12 weeks Receives: Other: Omega-3 acid ethyl esters |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting triglycerides levels
Noninferiority of phytosterol esters of omega-3 in affecting plasma fasting triglyceride levels in comparison with Omega-3 acids ethyl esters.
Measured: 12 weeks
Secondary outcomes (1)
Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels
Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daewon Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yossi Azuri, MD, Principal investigator, Maccabi Healthcare Services, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712867
- Sponsor's protocol ID
- Vayarol_006
- Status last verified
- Apr 2018
- First submitted
- 18 Oct 2012
- Last updated
- 11 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01712867
- Acronym / sponsor ID
- Vayarol_006
- Conditions
- Patients With Hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- EnzymotecIndustry (pharma, biotech, devices)
- Collaborators
- Daewon Pharmaceutical Co., Ltd.
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phytosterol esters of omega-3 | Experimental | Other: Phytosterol esters of omega-34 capsules/day for 12 weeks |
| Omega-3 acid ethyl esters | Active comparator | Other: Omega-3 acid ethyl esters4 capsules/day for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, age > 18 years
- Triglycerides ≥ 200 mg/dL and < 500 mg/dL
- Ability to give written informed consent
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 acid ethyl esters4 capsules/day for 12 weeks | Other | Omega-3 acid ethyl esters |
| Phytosterol esters of omega-34 capsules/day for 12 weeks | Other | Phytosterol esters of omega-3 |
Primary outcome
fasting triglycerides levels
Time frame: 12 weeks
Noninferiority of phytosterol esters of omega-3 in affecting plasma fasting triglyceride levels in comparison with Omega-3 acids ethyl esters.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yossi Azuri, MD principal investigator
Maccabi Healthcare Services, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 acid ethyl esters and Phytosterol esters of omega-3 in people with Patients With Hypertriglyceridemia, run by Enzymotec at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting triglycerides levels (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.