Carotid AtherosclerosisPhase 2NCT01743404
Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
A Phase 2 study testing Inflaminat in people with Carotid Atherosclerosis, run by Institute for Atherosclerosis Research, Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Carotid Atherosclerosis
- What is being tested?
- Inflaminat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2007to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Institute for Atherosclerosis Research
Moscow, Moscow
Igor Sobenin, MD, +79263590050, igor.sobenin@gmail.com
Ekaterina Chernova, +79166647123, katrincorde@gmail.com
About this study
Official title: Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
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.
- Conditions
- Carotid Atherosclerosis
- Being tested
- Inflaminat, Placebo
- Keywords
- atherosclerosis, inflammation, intima-media thickness
- Medical subject headings
- Carotid Artery Diseases, Atherosclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InflaminatDietary supplement
PlaceboDrug
Sugar pill manufactured to mimic Inflaminat 500 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Inflaminat | Active comparator | Inflaminat 500 mg tablet by mouth three times a day Receives: Dietary Supplement: Inflaminat |
| Sugar pill | Placebo comparator | Placebo 500 mg tablet by mouth three times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
B-mode ultrasound of carotid arteries
Variation of intima-media thickness of common carotid arteries
Measured: up to 2 years
Secondary outcomes (1)
Measure of serum atherogenicity
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startSep 2007
- Primary completionFeb 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Atherosclerosis Research, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743404
- Sponsor's protocol ID
- IAR-INFL
- Status last verified
- Sep 2012
- First submitted
- 2 Dec 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
- ClinicalTrials.gov ID
- NCT01743404
- Acronym / sponsor ID
- IAR-INFL
- Conditions
- Carotid Atherosclerosis
- Keywords
- atherosclerosis, inflammation, intima-media thickness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institute for Atherosclerosis Research, RussiaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflaminat | Active comparator | Dietary Supplement: InflaminatInflaminat 500 mg tablet by mouth three times a day |
| Sugar pill | Placebo comparator | Drug: PlaceboPlacebo 500 mg tablet by mouth three times a day |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflaminat | Dietary supplement | Inflaminat |
| PlaceboSugar pill manufactured to mimic Inflaminat 500 mg tablet | Drug | Sugar pill |
Primary outcome
B-mode ultrasound of carotid arteries
Time frame: up to 2 years
Variation of intima-media thickness of common carotid arteries
1 secondary outcome
Measure of serum atherogenicity
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inflaminat in people with Carotid Atherosclerosis, run by Institute for Atherosclerosis Research, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Igor Sobenin, MD (+79263590050, igor.sobenin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B-mode ultrasound of carotid arteries (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.