Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT02023892
Status:
UNKNOWN
Last Update Posted:
2014-05-15
First Post:
2013-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose of Atorvastatin and Circulating Endothelial Microparticles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-14', 'studyFirstSubmitDate': '2013-12-18', 'studyFirstSubmitQcDate': '2013-12-24', 'lastUpdatePostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of circulating endothelial microparticles', 'timeFrame': 'from 1h to 24h after taking atorvastatin'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endothelium', 'Hydroxymethylglutaryl-CoA Reductase Inhibitors']}, 'descriptionModule': {'briefSummary': 'Healthy subjects take single dose of 80mg atorvastatin, then measured their circulating endothelial microparticles and flow-mediated vasodilation in the brachial artery by ultrasound at different time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy youth\n\nExclusion Criteria:\n\n* acute pathologies\n* familial history of cardiovascular disease\n* smoking or drinking alcohol'}, 'identificationModule': {'nctId': 'NCT02023892', 'briefTitle': 'Single Dose of Atorvastatin and Circulating Endothelial Microparticles', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Effect of Single Dose of Atorvastatin on Change of Circulating Endothelial Microparticles', 'orgStudyIdInfo': {'id': 'YHuang002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'atorvastatin', 'description': 'atorvastatin 20mg tablet, single dose of 80mg by mouth', 'interventionNames': ['Drug: atorvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo 20mg tablet, single dose of 80mg by mouth', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'atorvastatin', 'type': 'DRUG', 'otherNames': ['Liptor'], 'armGroupLabels': ['atorvastatin']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['sugar pill manufactured to mimic atorvastatin 20mg tablet'], 'armGroupLabels': ['placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Pharmacology, Zhongshan School of Medicine', 'investigatorFullName': 'Yi-jun Huang, PhD', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}