Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
This study is currently recruiting participants.
Verified September 2012 by Institute for Atherosclerosis Research, Russia
Sponsor:
Institute for Atherosclerosis Research, Russia
Information provided by (Responsible Party):
Institute for Atherosclerosis Research, Russia
ClinicalTrials.gov Identifier:
NCT01743404
First received: December 2, 2012
Last updated: December 4, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carotid Atherosclerosis |
Dietary Supplement: Inflaminat Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
| Official Title: | Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis |
Resource links provided by NLM:
Further study details as provided by Institute for Atherosclerosis Research, Russia:
Primary Outcome Measures:
- B-mode ultrasound of carotid arteries [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]Variation of intima-media thickness of common carotid arteries
Secondary Outcome Measures:
- Measure of serum atherogenicity [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]Change of the ability of serum to induce cholesterol accumulation in cultured cells
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Inflaminat
Inflaminat 500 mg tablet by mouth three times a day
|
Dietary Supplement: Inflaminat |
|
Placebo Comparator: Sugar pill
Placebo 500 mg tablet by mouth three times a day
|
Drug: Placebo
Sugar pill manufactured to mimic Inflaminat 500 mg tablet
|
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743404
Contacts
| Contact: Igor Sobenin, MD | +79263590050 | igor.sobenin@gmail.com |
| Contact: Ekaterina Chernova | +79166647123 | katrincorde@gmail.com |
Locations
| Russian Federation | |
| Institute for Atherosclerosis Research | Recruiting |
| Moscow, Russian Federation | |
| Contact: Igor Sobenin, MD +79263590050 igor.sobenin@gmail.com | |
| Contact: Ekaterina Chernova +79166647123 katrincorde@gmail.com | |
Sponsors and Collaborators
Institute for Atherosclerosis Research, Russia
More Information
No publications provided
| Responsible Party: | Institute for Atherosclerosis Research, Russia |
| ClinicalTrials.gov Identifier: | NCT01743404 History of Changes |
| Other Study ID Numbers: | IAR-INFL |
| Study First Received: | December 2, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | Russia: Ethics Committee |
Keywords provided by Institute for Atherosclerosis Research, Russia:
|
atherosclerosis inflammation intima-media thickness |
Additional relevant MeSH terms:
|
Atherosclerosis Carotid Artery Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Cardiovascular Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013