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Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis

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ClinicalTrials.gov Identifier: NCT01743404
Recruitment Status : Unknown
Verified September 2012 by Institute for Atherosclerosis Research, Russia.
Recruitment status was:  Recruiting
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
Institute for Atherosclerosis Research, Russia

Brief Summary:
The purpose of this study is to investigate the anti-atherosclerotic effect of long-term anti-inflammatory therapy (Inflaminat) in asymptomatic participants with subclinical atherosclerosis of carotid arteries.

Condition or disease Intervention/treatment Phase
Carotid Atherosclerosis Dietary Supplement: Inflaminat Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
Study Start Date : September 2007
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Inflaminat
Inflaminat 500 mg tablet by mouth three times a day
Dietary Supplement: Inflaminat
Placebo Comparator: Sugar pill
Placebo 500 mg tablet by mouth three times a day
Drug: Placebo
Sugar pill manufactured to mimic Inflaminat 500 mg tablet



Primary Outcome Measures :
  1. B-mode ultrasound of carotid arteries [ Time Frame: up to 2 years ]
    Variation of intima-media thickness 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men aged 40 to 70 years
  • Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1000-2000 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 of stroke or transient ischemic attacks
  • Chronic diseases demanding drug administration more than during 2 month per year
  • Individual intolerance of Inflaminat 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): NCT01743404


Contacts
Contact: Igor Sobenin, MD +79263590050 igor.sobenin@gmail.com
Contact: Ekaterina Chernova +79166647123 katrincorde@gmail.com

Locations
Russian Federation
Institute for Atherosclerosis Research Recruiting
Moscow, Russian Federation
Contact: Igor Sobenin, MD    +79263590050    igor.sobenin@gmail.com   
Contact: Ekaterina Chernova    +79166647123    katrincorde@gmail.com   
Sponsors and Collaborators
Institute for Atherosclerosis Research, Russia

Responsible Party: Institute for Atherosclerosis Research, Russia
ClinicalTrials.gov Identifier: NCT01743404     History of Changes
Other Study ID Numbers: IAR-INFL
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: September 2012

Keywords provided by Institute for Atherosclerosis Research, Russia:
atherosclerosis
inflammation
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