Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT00240305
Status:
COMPLETED
Last Update Posted:
2009-03-16
First Post:
2005-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, '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': 'CROSSOVER'}, 'enrollmentInfo': {'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-13', 'studyFirstSubmitDate': '2005-10-16', 'studyFirstSubmitQcDate': '2005-10-17', 'lastUpdatePostDateStruct': {'date': '2009-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the dose-related effect of treatment with rosuvastatin on production & fractional catabolism of apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II), & on the plasma apoA-I, apoA-II & high-density lipoprotein cholesterol (HDL-C) c'}], 'secondaryOutcomes': [{'measure': 'Determine the dose-related effect of treatment with rosuvastatin on cellular cholesterol efflux,total cholesterol, low-density lipoprotein cholesterol (LDL-C), non-LDL-C, triglyceride & pre1-HDL concentrations,HDL2,HDL3 cholesterol ratio'}, {'measure': 'Cholesteryl ester transfer protein (CETP) and lecithin:cholesterol acyl transferase (LCAT) activity'}, {'measure': 'Lathosterol and campesterol, total apolipoprotein B (apoB), nonesterified fatty acids (NEFA) and apolipoprotein C-III (apoC-III) plasma concentrations.'}]}, 'conditionsModule': {'keywords': ['Metabolic Syndrome', 'Dyslipidaemia'], 'conditions': ['Metabolic Syndrome', 'Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '25816050', 'type': 'DERIVED', 'citation': 'Ng TW, Ooi EM, Watts GF, Chan DC, Meikle PJ, Barrett PH. Association of Plasma Ceramides and Sphingomyelin With VLDL apoB-100 Fractional Catabolic Rate Before and After Rosuvastatin Treatment. J Clin Endocrinol Metab. 2015 Jun;100(6):2497-501. doi: 10.1210/jc.2014-4348. Epub 2015 Mar 27.'}, {'pmid': '25140396', 'type': 'DERIVED', 'citation': 'Ng TW, Ooi EM, Watts GF, Chan DC, Weir JM, Meikle PJ, Barrett PH. Dose-dependent effects of rosuvastatin on the plasma sphingolipidome and phospholipidome in the metabolic syndrome. J Clin Endocrinol Metab. 2014 Nov;99(11):E2335-40. doi: 10.1210/jc.2014-1665. Epub 2014 Aug 20.'}, {'pmid': '18509206', 'type': 'DERIVED', 'citation': 'Ooi EM, Watts GF, Chan DC, Chen MM, Nestel PJ, Sviridov D, Barrett PH. Dose-dependent effect of rosuvastatin on VLDL-apolipoprotein C-III kinetics in the metabolic syndrome. Diabetes Care. 2008 Aug;31(8):1656-61. doi: 10.2337/dc08-0358. Epub 2008 May 28.'}, {'pmid': '17416370', 'type': 'DERIVED', 'citation': 'Ooi EM, Barrett PH, Chan DC, Nestel PJ, Watts GF. Dose-dependent effect of rosuvastatin on apolipoprotein B-100 kinetics in the metabolic syndrome. Atherosclerosis. 2008 Mar;197(1):139-46. doi: 10.1016/j.atherosclerosis.2007.03.004. Epub 2007 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the dose-related effect of treatment with rosuvastatin on production and fractional catabolism of apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II), and on the plasma apoA-I, apoA-II and high-density lipoprotein cholesterol (HDL-C) concentration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* male aged 30 to 70 years of age\n* LDL-C \\<6 mmol/L\n* HDL-C ≤1.2 mmol/L\n* at least 2 of the following:\n* insulin resistance (fasting glucose \\>6 mmol/L or insulin \\>10 mU/L or HOMA score \\>2.5)\n* central obesity (waist circumference \\>=94 cm).\n* plasma triglycerides \\>=1.7 and \\<4.5 mmol/L.\n* blood pressure \\>=130/ \\>=85 mm Hg or on drug treatment for hypertension\n\nExclusion Criteria:\n\n* LDL cholesterol \\>=6 mmol/L\n* pre-existing or history of cardiovascular disease, diabetes, renal dysfunction, anaemia, history of significant dyspepsia or gastrointestinal disease\n* apolipoprotein genotype E2/E2'}, 'identificationModule': {'nctId': 'NCT00240305', 'briefTitle': 'A Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Double-Blind, Placebo Controlled, Crossover Dose-Ranging Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome', 'orgStudyIdInfo': {'id': '4522AS/0004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Gerald F. Watts, BSc PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Department of Medicine, Royal Perth Hospital, University of Western Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}