NCT01743404UnknownPhase 2
Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
Institute for Atherosclerosis Research, Russia1 site in 1 country300 target enrollmentStarted: September 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- B-mode ultrasound of carotid arteries
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Sugar pill
Placebo Comparator
Placebo 500 mg tablet by mouth three times a day
Intervention: Placebo (Drug)
Inflaminat
Active Comparator
Inflaminat 500 mg tablet by mouth three times a day
Intervention: Inflaminat (Dietary Supplement)
Outcomes
Primary Outcomes
B-mode ultrasound of carotid arteries
Time Frame: up to 2 years
Variation of intima-media thickness of common carotid arteries
Secondary Outcomes
- Measure of serum atherogenicity(up to 2 years)
Investigators
Study Sites (1)
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