Atherosclerosis Monitoring and Atherogenicity Reduction Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institute for Atherosclerosis Research, Russia
ClinicalTrials.gov Identifier:
NCT01734707
First received: November 16, 2012
Last updated: November 21, 2012
Last verified: January 2005

November 16, 2012
November 21, 2012
January 2004
January 2005   (final data collection date for primary outcome measure)
high-resolution B-mode ultrasonography of common carotid arteries [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries
Same as current
Complete list of historical versions of study NCT01734707 on ClinicalTrials.gov Archive Site
Measure of serum atherogenicity [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Same as current
Not Provided
Not Provided
 
Atherosclerosis Monitoring and Atherogenicity Reduction Study
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Carotid Atherosclerosis
  • Dietary Supplement: Allicor
    Other Name: time-released garlic powder tablets
  • Drug: Placebo
    Sugar pill manufactured to mimic Allicor 150 mg tablet
  • Active Comparator: Allicor
    Allicor 150 mg tablet by mouth two times a day
    Intervention: Dietary Supplement: Allicor
  • Placebo Comparator: Sugar pill
    Placebo tablet 150 mg by mouth two times a day
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
October 2005
January 2005   (final data collection date for primary outcome measure)

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
Male
40 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01734707
IAR-AMAR
Not Provided
Institute for Atherosclerosis Research, Russia
Institute for Atherosclerosis Research, Russia
Not Provided
Not Provided
Institute for Atherosclerosis Research, Russia
January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP