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Atherosclerosis Monitoring and Atherogenicity Reduction Study

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ClinicalTrials.gov Identifier: NCT01734707
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Institute for Atherosclerosis Research, Russia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carotid Atherosclerosis Dietary Supplement: Allicor Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Study Start Date : January 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Allicor
Allicor 150 mg tablet by mouth two times a day
Dietary Supplement: Allicor
Other Name: time-released garlic powder tablets
Placebo Comparator: Sugar pill
Placebo tablet 150 mg by mouth two times a day
Drug: Placebo
Sugar pill manufactured to mimic Allicor 150 mg tablet



Primary Outcome Measures :
  1. high-resolution B-mode ultrasonography of common carotid arteries [ Time Frame: up to 2 years ]
    Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries


Secondary Outcome Measures :
  1. Measure of serum atherogenicity [ Time Frame: up to 2 years ]
    Change of the ability of serum to induce cholesterol accumulation in cultured cells



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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men aged 40 to 74 years
  • Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1100-2000 mcm)
  • Arterial normotension or mild arterial hypertension (systolic blood pressure <160 mm Hg, diastolic blood pressure <90 mm Hg)
  • Absence of chronic diseases demanding permanent drug administration (more than 2 month per year)

Exclusion Criteria:

  • Personal history or diagnostic of following diseases:

    1. Transient ischemic attacks
    2. Presence of chronic diseases demanding permanent drug administration (more than 2 month per year)
    3. Condition of patients moderate to severe
  • Indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system.
  • Individual intolerance of Allicor or appearance of side effects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734707


Locations
Russian Federation
Institute for Atherosclerosis Research
Moscow, Russian Federation
Sponsors and Collaborators
Institute for Atherosclerosis Research, Russia

Publications of Results:
Responsible Party: Institute for Atherosclerosis Research, Russia
ClinicalTrials.gov Identifier: NCT01734707     History of Changes
Other Study ID Numbers: IAR-AMAR
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: January 2005

Keywords provided by Institute for Atherosclerosis Research, Russia:
atherosclerosis
regression
Allicor
garlic
intima-media thickness

Additional relevant MeSH terms:
Atherosclerosis
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases