Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis

NCT ID: NCT01743404

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Carotid Atherosclerosis

Keywords

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atherosclerosis inflammation intima-media thickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Inflaminat

Inflaminat 500 mg tablet by mouth three times a day

Group Type ACTIVE_COMPARATOR

Inflaminat

Intervention Type DIETARY_SUPPLEMENT

Sugar pill

Placebo 500 mg tablet by mouth three times a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sugar pill manufactured to mimic Inflaminat 500 mg tablet

Interventions

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Inflaminat

Intervention Type DIETARY_SUPPLEMENT

Placebo

Sugar pill manufactured to mimic Inflaminat 500 mg tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Institute for Atherosclerosis Research, Russia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute for Atherosclerosis Research

Moscow, Moscow, Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Igor Sobenin, MD

Role: CONTACT

Phone: +79263590050

Email: [email protected]

Ekaterina Chernova

Role: CONTACT

Phone: +79166647123

Email: [email protected]

Facility Contacts

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Igor Sobenin, MD

Role: primary

Ekaterina Chernova

Role: backup

Other Identifiers

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IAR-INFL

Identifier Type: -

Identifier Source: org_study_id