Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-20 @ 10:10 PM
Study NCT ID:
NCT00654394
Status:
COMPLETED
Last Update Posted:
2009-03-16
First Post:
2008-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-13', 'studyFirstSubmitDate': '2008-04-03', 'studyFirstSubmitQcDate': '2008-04-03', 'lastUpdatePostDateStruct': {'date': '2009-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in carotid wall volume as measured by MRI scan', 'timeFrame': 'At 40 weeks and 104 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety: adverse events & abnormal laboratory markers', 'timeFrame': '2 weekly for first 4 weeks then 4 weekly'}, {'measure': 'Other changes in the structure and composition of the carotid arterial wall as defined in the protocol.', 'timeFrame': 'At 40 weeks and 104 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cholesterol', 'Carotid Artery Stenosis', 'Hypercholesterolemia', 'Rosuvastatin', 'Crestor'], 'conditions': ['Carotid Artery Stenosis', 'Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '37565307', 'type': 'DERIVED', 'citation': 'Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting blood low density lipoprotein cholesterol level as defined by the protocol\n* Diagnosed carotid arterial stenosis\n\nExclusion Criteria:\n\n* The use of lipid lowering drugs or dietary supplements after Visit 1.\n* Heavy or total occlusion of the carotid artery or recent stroke\n* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT00654394', 'briefTitle': 'Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Randomized, Double-Blind, Multicenter, Trial to Assess the Effect of High & Low Doses of ZD4522 on Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects With Asymptomatic Carotid Stenosis After 24 Months of Dosing.', 'orgStudyIdInfo': {'id': '4522IL/0044'}, 'secondaryIdInfos': [{'id': 'D3560C00044'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Rosuvastatin']}], 'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Crestor'], 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tom Hatsukami', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington, USA'}, {'name': 'Russell Esterline', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Elisabeth Björk', 'oldOrganization': 'AstraZeneca'}}}}