<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01712867</url>
  </required_header>
  <id_info>
    <org_study_id>Vayarol_006</org_study_id>
    <nct_id>NCT01712867</nct_id>
  </id_info>
  <brief_title>The Effect of Phytosterol Esters of Omega-3 (Vayarol) Versus Omega-3 Acids Ethyl Esters in Reducing Triglyceride Levels</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enzymotec</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daewon Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Enzymotec</source>
  <brief_summary>
    <textblock>
      The primary objective is to determine the efficacy of phytosterol esters of omega-3 (Vayarol)&#xD;
      versus Omega-3 acids ethyl esters in reducing triglyceride levels in hypertriglyceridemia&#xD;
      patients with fasting triglyceride levels ≥ 200 and &lt; 500 mg/dL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fasting triglycerides levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>Noninferiority of phytosterol esters of omega-3 in affecting plasma fasting triglyceride levels in comparison with Omega-3 acids ethyl esters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Patients With Hypertriglyceridemia</condition>
  <arm_group>
    <arm_group_label>Phytosterol esters of omega-3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 capsules/day for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omega-3 acid ethyl esters</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 capsules/day for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Omega-3 acid ethyl esters</intervention_name>
    <description>4 capsules/day for 12 weeks</description>
    <arm_group_label>Omega-3 acid ethyl esters</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Phytosterol esters of omega-3</intervention_name>
    <description>4 capsules/day for 12 weeks</description>
    <arm_group_label>Phytosterol esters of omega-3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, age &gt; 18 years&#xD;
&#xD;
          2. Triglycerides ≥ 200 mg/dL and &lt; 500 mg/dL&#xD;
&#xD;
          3. Ability to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female patient who are pregnant or breastfeeding or planning to become pregnant&#xD;
&#xD;
          2. Fasting plasma glucose (FPG) levels &gt; 110 mg/dL&#xD;
&#xD;
          3. Type 2 diabetes mellitus that is poorly controlled (glycosylated hemoglobin [HbAlc ]&#xD;
             &gt;8.0%&#xD;
&#xD;
          4. Patients who are under use of lipid altering drugs excluding use of Simvastatin,&#xD;
             Atorvastatin, and Rosovastatin for 6 weeks or more&#xD;
&#xD;
          5. Patients who are under use of products containing omega-3 fatty acids or other dietary&#xD;
             supplements with potential lipid altering effects&#xD;
&#xD;
          6. History of bariatric surgery or currently on weight loss drugs.&#xD;
&#xD;
          7. Uncontrolled hypertension (BP&gt;140/90)&#xD;
&#xD;
          8. Subjects with secondary causes of hypertriglyceridemia: alcoholism, dysglobulinemia,&#xD;
             thyroid disease that is poorly controlled (TSH&lt;0.35 or TSH&gt;5.5)&#xD;
&#xD;
          9. Subjects with an abnormal level of liver enzymes (twice the normal level)&#xD;
&#xD;
         10. Suffered from ischemic event such as myocardial infarction, cerebrovascular accident&#xD;
             and angina pectoris in the last 6 months&#xD;
&#xD;
         11. Uncontrolled endocrine or metabolic disease known to influence serum lipids or&#xD;
             lipoproteins such as cushing syndrome&#xD;
&#xD;
         12. Gastrointestinal disease that may influence lipid metabolism such as celiac, crohn,&#xD;
             colitis or other malabsorption problem&#xD;
&#xD;
         13. Subjects who have had any malignancy. Subjects who have had basal cell carcinoma that&#xD;
             have been disease free for at least 3 years are eligible for the study.&#xD;
&#xD;
         14. Consumption of one fish serving (200 grams) or sea food x2 a week or more.&#xD;
&#xD;
         15. HIV infection by history&#xD;
&#xD;
         16. History of hypersensitivity or allergy to fish, fish oil or soy&#xD;
&#xD;
         17. BMI≥35&#xD;
&#xD;
         18. Weight change &gt; 3 kg during the run-in period&#xD;
&#xD;
         19. Any other reason that, in the opinion of the investigator, prevents the subject from&#xD;
             participating in the study or compromise the patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yossi Azuri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maccabi Healthcare Services, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maccabi Healthcare Services</name>
      <address>
        <city>Tel-Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertriglyceridemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01712867
org study id: Vayarol_006
nct id: NCT01712867
lead sponsor: 
collaborator: 
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: fasting triglycerides levels
time frame: 12 weeks
description: Noninferiority of phytosterol esters of omega-3 in affecting plasma fasting triglyceride levels in comparison with Omega-3 acids ethyl esters.
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
description: Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels
arm group label: Phytosterol esters of omega-3
arm group type: Experimental
description: 4 capsules/day for 12 weeks
arm group label: Omega-3 acid ethyl esters
arm group type: Active Comparator
description: 4 capsules/day for 12 weeks
intervention type: Other
intervention name: Omega-3 acid ethyl esters
description: 4 capsules/day for 12 weeks
arm group label: Omega-3 acid ethyl esters
intervention type: Other
intervention name: Phytosterol esters of omega-3
description: 4 capsules/day for 12 weeks
arm group label: Phytosterol esters of omega-3
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yossi Azuri, MD
role: Principal Investigator
affiliation: Maccabi Healthcare Services, Israel
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Hypertriglyceridemia