Carotid AtherosclerosisPhase 3NCT01734707
Atherosclerosis Monitoring and Atherogenicity Reduction Study
A Phase 3 study testing Allicor in people with Carotid Atherosclerosis, run by Institute for Atherosclerosis Research, Russia at 1 site in Russia.
Trial summary
This study was designed to estimate the effect of two-year treatment with time-released garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded placebo-controlled randomized clinical trial. Read more about this study
- Who is it for?
- Ages 40 to 74 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Carotid Atherosclerosis
- What is being tested?
- Allicor
- 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
- Jan 2004to Oct 2005
- Phase
- Phase 3
- 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 74 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men aged 40 to 74 years
- Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1100-2000 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 or diagnostic of following diseases:
- Transient ischemic attacks
- Presence of chronic diseases demanding permanent drug administration (more than 2 month per year)
- Condition of patients moderate to severe
- Indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system.
- Individual intolerance of Allicor or appearance of side effects
Trial locations and contacts
1 site in 1 country.
About this study
This study was designed to estimate the effect of two-year treatment with time-released garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded placebo-controlled randomized clinical trial.
- Conditions
- Carotid Atherosclerosis
- Being tested
- Allicor, Placebo
- Keywords
- atherosclerosis, regression, Allicor, garlic, intima-media thickness
- Medical subject headings
- Carotid Artery Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllicorDietary supplement
Also called time-released garlic powder tablets
PlaceboDrug
Sugar pill manufactured to mimic Allicor 150 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Allicor | Active comparator | Allicor 150 mg tablet by mouth two times a day Receives: Dietary Supplement: Allicor |
| Sugar pill | Placebo comparator | Placebo tablet 150 mg by mouth two times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
high-resolution B-mode ultrasonography of common carotid arteries
Variation in carotid intima-media thickness (IMT) of the far wall 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 posted28 Nov 2012 (estimated)
- Study startJan 2004
- Primary completionJan 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (actual)
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
- NCT01734707
- Sponsor's protocol ID
- IAR-AMAR
- Status last verified
- Jan 2005
- First submitted
- 16 Nov 2012
- Last updated
- 28 Nov 2012
- Results posted
- No
Publications
Sobenin IA, Pryanishnikov VV, Kunnova LM, Rabinovich YA, Martirosyan DM, Orekhov AN. The effects of time-released garlic powder tablets on multifunctional cardiovascular risk in patients with coronary artery disease. Lipids Health Dis. 2010 Oct 19;9:119. doi: 10.1186/1476-511X-9-119.
PubMed 20958974
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atherosclerosis Monitoring and Atherogenicity Reduction Study
- ClinicalTrials.gov ID
- NCT01734707
- Acronym / sponsor ID
- IAR-AMAR
- Conditions
- Carotid Atherosclerosis
- Keywords
- atherosclerosis, regression, Allicor, garlic, intima-media thickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Institute for Atherosclerosis Research, RussiaUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 28 Nov 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.
This study was designed to estimate the effect of two-year treatment with time-released garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded placebo-controlled randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allicor | Active comparator | Dietary Supplement: AllicorAllicor 150 mg tablet by mouth two times a day |
| Sugar pill | Placebo comparator | Drug: PlaceboPlacebo tablet 150 mg by mouth two times a day |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men aged 40 to 74 years
- Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1100-2000 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 (6 listed)
- Personal history or diagnostic of following diseases:
- Indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system.
- Individual intolerance of Allicor 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 |
|---|---|---|
| AllicorAlso: time-released garlic powder tablets | Dietary supplement | Allicor |
| PlaceboSugar pill manufactured to mimic Allicor 150 mg tablet | Drug | Sugar pill |
Primary outcome
high-resolution B-mode ultrasonography of common carotid arteries
Time frame: up to 2 years
Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries
1 secondary outcome
Measure of serum atherogenicity
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
- Results publication: PubMed 20958974Sobenin IA, Pryanishnikov VV, Kunnova LM, Rabinovich YA, Martirosyan DM, Orekhov AN. The effects of time-released garlic powder tablets on multifunctional cardiovascular risk in patients with coronary artery disease. Lipids Health Dis. 2010 Oct 19;9:119. doi: 10.1186/1476-511X-9-119.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allicor 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 6 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: finished, as of the sponsor's last update on 28 Nov 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high-resolution B-mode ultrasonography of common 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?
On the ClinicalTrials.gov record for NCT01734707, which also lists 1 linked publication.
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 28 Nov 2012.