Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT00654602
Status:
COMPLETED
Last Update Posted:
2009-05-28
First Post:
2008-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-27', 'studyFirstSubmitDate': '2008-04-03', 'studyFirstSubmitQcDate': '2008-04-03', 'lastUpdatePostDateStruct': {'date': '2009-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in low density lipoprotein cholesterol levels', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Reduction in low density lipoprotein cholesterol levels', 'timeFrame': '24 & 48 weeks'}, {'measure': 'Safety: adverse events & abnormal laboratory markers', 'timeFrame': '4 weekly until week 12 then 12 weekly thereafter.'}, {'measure': 'Maintenance of lowered low density lipoprotein cholesterol level', 'timeFrame': 'Between week 12-48'}]}, 'conditionsModule': {'keywords': ['cholesterol', 'low density lipoproteins', 'dyslipidaemia', 'Rosuvastatin', 'Crestor'], 'conditions': ['Dyslipidaemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting low density lipoprotein level as defined by the protocol.\n* Fasting triglyceride level as defined by the protocol.\n\nExclusion Criteria:\n\n* The use of lipid lowering drugs or dietary supplements after Visit 1.\n* Active arterial disease eg Unstable angina, or recent arterial surgery.\n* Blood lipid levels above the limits defined in the protocol.\n* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.'}, 'identificationModule': {'nctId': 'NCT00654602', 'briefTitle': '48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia.', 'orgStudyIdInfo': {'id': '4522IL/0091'}, 'secondaryIdInfos': [{'id': 'D3560C00091'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Crestor']}, {'name': 'Maintenance of specific diet', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dr. Evan Stein', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Metabolic & Athersclerotic research centre, USA'}, {'name': 'Russell Esterline', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}