Back to resultsStudy of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
Primary Purpose
Carotid Atherosclerosis
Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Inflaminat
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Carotid Atherosclerosis focused on measuring atherosclerosis, inflammation, intima-media thickness
Eligibility 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
Sites / Locations
- Institute for Atherosclerosis ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Inflaminat
Sugar pill
Arm Description
Inflaminat 500 mg tablet by mouth three times a day
Placebo 500 mg tablet by mouth three times a day
Outcomes
Primary Outcome Measures
B-mode ultrasound of carotid arteries
Variation of intima-media thickness of common carotid arteries
Secondary Outcome Measures
Measure of serum atherogenicity
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Full Information
NCT ID
NCT01743404
First Posted
December 2, 2012
Last Updated
December 4, 2012
Sponsor
Institute for Atherosclerosis Research, Russia
1. Study Identification
Unique Protocol Identification Number
NCT01743404
Brief Title
Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
Official Title
Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Atherosclerosis Research, Russia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Atherosclerosis
Keywords
atherosclerosis, inflammation, intima-media thickness
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inflaminat
Arm Type
Active Comparator
Arm Description
Inflaminat 500 mg tablet by mouth three times a day
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo 500 mg tablet by mouth three times a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Inflaminat
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sugar pill manufactured to mimic Inflaminat 500 mg tablet
Primary Outcome Measure Information:
Title
B-mode ultrasound of carotid arteries
Description
Variation of intima-media thickness of common carotid arteries
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Measure of serum atherogenicity
Description
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Time Frame
up to 2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Igor Sobenin, MD
Phone
+79263590050
Email
igor.sobenin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ekaterina Chernova
Phone
+79166647123
Email
katrincorde@gmail.com
Facility Information:
Facility Name
Institute for Atherosclerosis Research
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor Sobenin, MD
Phone
+79263590050
Email
igor.sobenin@gmail.com
First Name & Middle Initial & Last Name & Degree
Ekaterina Chernova
Phone
+79166647123
Email
katrincorde@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
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