Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-17 @ 12:19 PM
Study NCT ID:
NCT01666704
Status:
WITHDRAWN
Last Update Posted:
2013-06-21
First Post:
2012-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624964', 'term': 'BMS-823778'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-19', 'studyFirstSubmitDate': '2012-08-14', 'studyFirstSubmitQcDate': '2012-08-14', 'lastUpdatePostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of BMS-823778 versus placebo on carotids and/or ascending aortic will be measured by fluorodeoxyglucose (FDG) uptake in the index vessel as by positron emission tomography (PET) imaging', 'timeFrame': 'Day 168'}], 'secondaryOutcomes': [{'measure': 'Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices)', 'timeFrame': 'Day 364', 'description': 'Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices): total vessel area, wall area, wall thickness, and wall area/total vessel area ratio (normalized wall index), based on the average of the right and left carotids, measured by Magnetic Resonance Imaging (MRI)'}, {'measure': 'Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores', 'timeFrame': 'Approximately up to 60 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atherosclerotic Cardiovascular Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular event\n* On stable statin dose\n* Clinically stable at time of screening and randomization\n\nExclusion Criteria:\n\n* Women of child bearing potential\n* Medical conditions that would impact the absorption of the study drug'}, 'identificationModule': {'nctId': 'NCT01666704', 'briefTitle': 'Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Effects of BMS-823778 on Atherosclerotic Plaque Inflammation as Measured by Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET) in Patients With Atherosclerotic Cardiovascular Disease', 'orgStudyIdInfo': {'id': 'MB121-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A: BMS-823778 (2mg)', 'interventionNames': ['Drug: BMS-823778']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: BMS-823778 (15mg)', 'interventionNames': ['Drug: BMS-823778']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment C: Placebo', 'interventionNames': ['Drug: Placebo matching with BMS-823778']}], 'interventions': [{'name': 'BMS-823778', 'type': 'DRUG', 'description': 'Capsules, Oral, 2mg, Once daily, 1 year', 'armGroupLabels': ['Treatment A: BMS-823778 (2mg)']}, {'name': 'BMS-823778', 'type': 'DRUG', 'description': 'Capsules, Oral, 15mg, Once daily, 1 year', 'armGroupLabels': ['Treatment B: BMS-823778 (15mg)']}, {'name': 'Placebo matching with BMS-823778', 'type': 'DRUG', 'description': 'Capsules, Oral, 0mg, Once daily, 1 year', 'armGroupLabels': ['Treatment C: Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}