Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 2, 2012
CompletedFirst Posted
Study publicly available on registry
December 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedDecember 6, 2012
September 1, 2012
5.4 years
December 2, 2012
December 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
B-mode ultrasound of carotid arteries
Variation of intima-media thickness of common carotid arteries
up to 2 years
Secondary Outcomes (1)
Measure of serum atherogenicity
up to 2 years
Study Arms (2)
Inflaminat
ACTIVE COMPARATORInflaminat 500 mg tablet by mouth three times a day
Sugar pill
PLACEBO COMPARATORPlacebo 500 mg tablet by mouth three times a day
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Atherosclerosis Research
Moscow, Moscow, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2012
First Posted
December 6, 2012
Study Start
September 1, 2007
Primary Completion
February 1, 2013
Study Completion
June 1, 2013
Last Updated
December 6, 2012
Record last verified: 2012-09