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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

Tracking Information
First Submitted Date  ICMJE December 2, 2012
First Posted Date  ICMJE December 6, 2012
Last Update Posted Date December 6, 2012
Study Start Date  ICMJE September 2007
Estimated Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
B-mode ultrasound of carotid arteries [ Time Frame: up to 2 years ]
Variation of intima-media thickness of common carotid arteries
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
Measure of serum atherogenicity [ Time Frame: up to 2 years ]
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
Official Title  ICMJE Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Carotid Atherosclerosis
Intervention  ICMJE
  • Dietary Supplement: Inflaminat
  • Drug: Placebo
    Sugar pill manufactured to mimic Inflaminat 500 mg tablet
Study Arms  ICMJE
  • Active Comparator: Inflaminat
    Inflaminat 500 mg tablet by mouth three times a day
    Intervention: Dietary Supplement: Inflaminat
  • Placebo Comparator: Sugar pill
    Placebo 500 mg tablet by mouth three times a day
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 4, 2012)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2013
Estimated Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01743404
Other Study ID Numbers  ICMJE IAR-INFL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institute for Atherosclerosis Research, Russia
Study Sponsor  ICMJE Institute for Atherosclerosis Research, Russia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institute for Atherosclerosis Research, Russia
Verification Date September 2012

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