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

Carotid Atherosclerosis Clinical Trial

Official title:

Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01743404
• Other study ID #: IAR-INFL
• Status: Recruiting
• Phase: Phase 2
• First received: December 2, 2012
• Last updated: December 4, 2012
• Start date: September 2007
• Est. completion date: June 2013

Study information

• Verified date: September 2012
• Source: Institute for Atherosclerosis Research, Russia
• Contact: Igor Sobenin, MD
• Phone: +79263590050
• Email: igor.sobenin[@]gmail.com
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis

Intervention

Dietary Supplement:
• Inflaminat

Drug:
• Placebo
Sugar pill manufactured to mimic Inflaminat 500 mg tablet

Locations

Country	Name	City	State
Russian Federation	Institute for Atherosclerosis Research	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Atherosclerosis Research, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	B-mode ultrasound of carotid arteries	Variation of intima-media thickness of common carotid arteries	up to 2 years	Yes
Secondary	Measure of serum atherogenicity	Change of the ability of serum to induce cholesterol accumulation in cultured cells	up to 2 years	Yes