Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT00861861
Status:
COMPLETED
Last Update Posted:
2013-10-14
First Post:
2009-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108475', 'term': 'pitavastatin'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-11', 'studyFirstSubmitDate': '2009-03-12', 'studyFirstSubmitQcDate': '2009-03-13', 'lastUpdatePostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin)', 'timeFrame': 'start, 6 months, 12 months, 30 months'}], 'secondaryOutcomes': [{'measure': 'TC; LDL-C; HDL-C; HDL2-C; HDL3-C; TG; smalldenseLDL; MDA-LDL; FPG; HbA1c; Cr; RLP-C; apoA-I; apoB; apoC-Ⅱ; apoC-Ⅲ', 'timeFrame': 'start, 6 months, 12 months, 30 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pitavastatin', 'Atorvastatin', 'CAD', 'HDL-C', 'Adiponectin'], 'conditions': ['Hypercholesterolemia', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of pitavastatin and atorvastatin on adiponectin percentage change in patients with hypercholesteremia comorbid stable CAD.', 'detailedDescription': 'The efficiency of lipid lowering therapy was already proven by the clinical trials of statins. According to these results, the target value of LDL-C is recommended under 100mg/dL in the Japan Atherosclerosis Society Guidelines. However, the efficiency of intensive therapy to lower LDL-C more than 100mg/dL has not been proven yet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with dyslipidemia as defined by any of the parameters:\n\n * HDL-C \\< 50 mg/dL\n * LDL-C ≥ 140 mg/dL\n * LDL-C ≥ 100 mg/dL and cholesterol-lowering treatment is necessary in accordance with the investigator's judgement\n* Patients who passed three months or more after acute myocardial infarction\n* Patients who passed one month or more after unstable angina\n* Patients who passed one month or more after PCI\n* Patients with written consent by their own volition after being provided sufficient explanation for the participation into this clinical trial\n\nExclusion Criteria:\n\n* Patients with any allergy to pitavastatin or atorvastatin\n* Patients with familial hypercholesterolemia\n* Patients receiving pitavastatin\n* Patients with severe hypertension\n* Patients with renal disorders or undergoing dialysis\n* Patients with hepatobiliary disorders\n* Patients with hepatobiliary disorders\n* Patients with family history of hypothyroidism or muscular dystrophy\n* Patients with history of drug-induced hepatic disorder\n* Drug abuser or dipsomaniac\n* Patients with cardiogenic shock.\n* Patients who hopes for pregnancy during this study\n* Contraindications, Relative Contraindications, Absolute Contraindications for Coadministration and Relative Contraindications for Coadministration for pitavastatin or atorvastatin\n* Patients who are ineligible in the opinion of the investigator"}, 'identificationModule': {'nctId': 'NCT00861861', 'acronym': 'COMPACT-CAD', 'briefTitle': 'Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)', 'organization': {'class': 'OTHER', 'fullName': 'Kumamoto University'}, 'officialTitle': 'Comparison of Pitavastatin With Atorvastatin in Increasing HDL-C and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease.', 'orgStudyIdInfo': {'id': 'Kumamoto-746'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'pitavastatin group', 'interventionNames': ['Drug: Pitavastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'atorvastatin group', 'interventionNames': ['Drug: Atorvastatin']}], 'interventions': [{'name': 'Pitavastatin', 'type': 'DRUG', 'description': 'comparison of two drugs in increasing HDL-C and adiponectin', 'armGroupLabels': ['1']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'comparison of two drugs in increasing HDL-C and adiponectin', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '860-8556', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto University Graduate School of Medical Sciences Department of Cardiocascular Medicine', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}], 'overallOfficials': [{'name': 'Hisao Ogawa, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kumamoto University Graduate School of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kumamoto University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kumamoto University', 'investigatorFullName': 'Hisao Ogawa', 'investigatorAffiliation': 'Kumamoto University'}}}}