Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-25 @ 4:04 AM
Study NCT ID:
NCT01743404
Status:
UNKNOWN
Last Update Posted:
2012-12-06
First Post:
2012-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2012-12-02', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'B-mode ultrasound of carotid arteries', 'timeFrame': 'up to 2 years', 'description': 'Variation of intima-media thickness of common carotid arteries'}], 'secondaryOutcomes': [{'measure': 'Measure of serum atherogenicity', 'timeFrame': 'up to 2 years', 'description': 'Change of the ability of serum to induce cholesterol accumulation in cultured cells'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atherosclerosis', 'inflammation', 'intima-media thickness'], 'conditions': ['Carotid Atherosclerosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged 40 to 70 years\n* Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1000-2000 mcm)\n* Arterial normotension or mild arterial hypertension (systolic blood pressure \\<160 mm Hg, diastolic blood pressure \\<90 mm Hg)\n* Absence of chronic diseases demanding permanent drug administration (more than 2 month per year)\n\nExclusion Criteria:\n\n* Personal history of stroke or transient ischemic attacks\n* Chronic diseases demanding drug administration more than during 2 month per year\n* Individual intolerance of Inflaminat or appearance of side effects'}, 'identificationModule': {'nctId': 'NCT01743404', 'briefTitle': 'Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Institute for Atherosclerosis Research, Russia'}, 'officialTitle': 'Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis', 'orgStudyIdInfo': {'id': 'IAR-INFL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Inflaminat', 'description': 'Inflaminat 500 mg tablet by mouth three times a day', 'interventionNames': ['Dietary Supplement: Inflaminat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'description': 'Placebo 500 mg tablet by mouth three times a day', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Inflaminat', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Inflaminat']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sugar pill manufactured to mimic Inflaminat 500 mg tablet', 'armGroupLabels': ['Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'state': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Igor Sobenin, MD', 'role': 'CONTACT', 'email': 'igor.sobenin@gmail.com', 'phone': '+79263590050'}, {'name': 'Ekaterina Chernova', 'role': 'CONTACT', 'email': 'katrincorde@gmail.com', 'phone': '+79166647123'}], 'facility': 'Institute for Atherosclerosis Research', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Igor Sobenin, MD', 'role': 'CONTACT', 'email': 'igor.sobenin@gmail.com', 'phone': '+79263590050'}, {'name': 'Ekaterina Chernova', 'role': 'CONTACT', 'email': 'katrincorde@gmail.com', 'phone': '+79166647123'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Atherosclerosis Research, Russia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}