<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/NCT01734707</url>
  </required_header>
  <id_info>
    <org_study_id>IAR-AMAR</org_study_id>
    <nct_id>NCT01734707</nct_id>
  </id_info>
  <brief_title>Atherosclerosis Monitoring and Atherogenicity Reduction Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute for Atherosclerosis Research, Russia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute for Atherosclerosis Research, Russia</source>
  <brief_summary>
    <textblock>
      This study was designed to estimate the effect of two-year treatment with time-released&#xD;
      garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded&#xD;
      placebo-controlled randomized clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2004</start_date>
  <completion_date type="Actual">October 2005</completion_date>
  <primary_completion_date type="Actual">January 2005</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>high-resolution B-mode ultrasonography of common carotid arteries</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of serum atherogenicity</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Change of the ability of serum to induce cholesterol accumulation in cultured cells</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Carotid Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>Allicor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Allicor 150 mg tablet by mouth two times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablet 150 mg by mouth two times a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Allicor</intervention_name>
    <arm_group_label>Allicor</arm_group_label>
    <other_name>time-released garlic powder tablets</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sugar pill manufactured to mimic Allicor 150 mg tablet</description>
    <arm_group_label>Sugar pill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men aged 40 to 74 years&#xD;
&#xD;
          -  Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased&#xD;
             intima-media thickness 1100-2000 mcm)&#xD;
&#xD;
          -  Arterial normotension or mild arterial hypertension (systolic blood pressure &lt;160 mm&#xD;
             Hg, diastolic blood pressure &lt;90 mm Hg)&#xD;
&#xD;
          -  Absence of chronic diseases demanding permanent drug administration (more than 2 month&#xD;
             per year)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal history or diagnostic of following diseases:&#xD;
&#xD;
               1. Transient ischemic attacks&#xD;
&#xD;
               2. Presence of chronic diseases demanding permanent drug administration (more than 2&#xD;
                  month per year)&#xD;
&#xD;
               3. Condition of patients moderate to severe&#xD;
&#xD;
          -  Indications for surgical treatment of atherosclerotic lesions localized in the&#xD;
             extracranial brachiocephalic system.&#xD;
&#xD;
          -  Individual intolerance of Allicor or appearance of side effects&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute for Atherosclerosis Research</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <results_reference>
    <citation>Sobenin IA, Pryanishnikov VV, Kunnova LM, Rabinovich YA, Martirosyan DM, Orekhov AN. The effects of time-released garlic powder tablets on multifunctional cardiovascular risk in patients with coronary artery disease. Lipids Health Dis. 2010 Oct 19;9:119. doi: 10.1186/1476-511X-9-119.</citation>
    <PMID>20958974</PMID>
  </results_reference>
  <verification_date>January 2005</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>November 21, 2012</last_update_submitted>
  <last_update_submitted_qc>November 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atherosclerosis</keyword>
  <keyword>regression</keyword>
  <keyword>Allicor</keyword>
  <keyword>garlic</keyword>
  <keyword>intima-media thickness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Artery Diseases</mesh_term>
    <mesh_term>Atherosclerosis</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/NCT01734707
org study id: IAR-AMAR
nct id: NCT01734707
lead sponsor: 
This study was designed to estimate the effect of two-year treatment with time-released
      garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded
      placebo-controlled randomized clinical trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: high-resolution B-mode ultrasonography of common carotid arteries
time frame: up to 2 years
description: Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries
measure: Measure of serum atherogenicity
time frame: up to 2 years
description: Change of the ability of serum to induce cholesterol accumulation in cultured cells
arm group label: Allicor
arm group type: Active Comparator
description: Allicor 150 mg tablet by mouth two times a day
arm group label: Sugar pill
arm group type: Placebo Comparator
description: Placebo tablet 150 mg by mouth two times a day
intervention type: Dietary Supplement
intervention name: Allicor
arm group label: Allicor
other name: time-released garlic powder tablets
intervention type: Drug
intervention name: Placebo
description: Sugar pill manufactured to mimic Allicor 150 mg tablet
arm group label: Sugar pill
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Russian Federation
citation: Sobenin IA, Pryanishnikov VV, Kunnova LM, Rabinovich YA, Martirosyan DM, Orekhov AN. The effects of time-released garlic powder tablets on multifunctional cardiovascular risk in patients with coronary artery disease. Lipids Health Dis. 2010 Oct 19;9:119. doi: 10.1186/1476-511X-9-119.
PMID: 20958974
responsible party type: Sponsor
mesh term: Carotid Artery Diseases
mesh term: Atherosclerosis