- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01743404
Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
December 4, 2012 updated by: Institute for Atherosclerosis Research, Russia
Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Igor Sobenin, MD
- Phone Number: +79263590050
- Email: igor.sobenin@gmail.com
Study Contact Backup
- Name: Ekaterina Chernova
- Phone Number: +79166647123
- Email: katrincorde@gmail.com
Study Locations
-
-
-
Moscow, Russian Federation
- Recruiting
- Institute for Atherosclerosis Research
-
Contact:
- Igor Sobenin, MD
- Phone Number: +79263590050
- Email: igor.sobenin@gmail.com
-
Contact:
- Ekaterina Chernova
- Phone Number: +79166647123
- Email: katrincorde@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Inflaminat
Inflaminat 500 mg tablet by mouth three times a day
|
|
Placebo Comparator: Sugar pill
Placebo 500 mg tablet by mouth three times a day
|
Sugar pill manufactured to mimic Inflaminat 500 mg tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
B-mode ultrasound of carotid arteries
Time Frame: up to 2 years
|
Variation of intima-media thickness of common carotid arteries
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of serum atherogenicity
Time Frame: up to 2 years
|
Change of the ability of serum to induce cholesterol accumulation in cultured cells
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Anticipated)
February 1, 2013
Study Completion (Anticipated)
June 1, 2013
Study Registration Dates
First Submitted
December 2, 2012
First Submitted That Met QC Criteria
December 4, 2012
First Posted (Estimate)
December 6, 2012
Study Record Updates
Last Update Posted (Estimate)
December 6, 2012
Last Update Submitted That Met QC Criteria
December 4, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IAR-INFL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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