Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT01011127
Status:
COMPLETED
Last Update Posted:
2010-10-05
First Post:
2009-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different Metabolic Effects of Statins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017035', 'term': 'Pravastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-04', 'studyFirstSubmitDate': '2009-11-10', 'studyFirstSubmitQcDate': '2009-11-10', 'lastUpdatePostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Statins', 'Insulin resistance'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '10205010', 'type': 'BACKGROUND', 'citation': 'Yada T, Nakata M, Shiraishi T, Kakei M. Inhibition by simvastatin, but not pravastatin, of glucose-induced cytosolic Ca2+ signalling and insulin secretion due to blockade of L-type Ca2+ channels in rat islet beta-cells. Br J Pharmacol. 1999 Mar;126(5):1205-13. doi: 10.1038/sj.bjp.0702397.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that pravastatin and rosuvastatin may have different metabolic effects in hypercholesterolemic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hypercholesterolemia', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low-density lipoprotein cholesterol levels\\>130\n\nExclusion Criteria:\n\n* Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension'}, 'identificationModule': {'nctId': 'NCT01011127', 'briefTitle': 'Different Metabolic Effects of Statins', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'orgStudyIdInfo': {'id': 'GMC-200914'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pravastatin', 'interventionNames': ['Drug: pravastatin, rosuvastatin']}, {'label': 'rosuvastatin', 'interventionNames': ['Drug: pravastatin, rosuvastatin']}], 'interventions': [{'name': 'pravastatin, rosuvastatin', 'type': 'DRUG', 'armGroupLabels': ['pravastatin', 'rosuvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '405-760', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}}}}