Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT00846118
Status:
TERMINATED
Last Update Posted:
2021-08-30
First Post:
2009-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis (DIALYSIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108475', 'term': 'pitavastatin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 905}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'interventions for ischemic heart disease', 'timeFrame': 'whole observational period'}, {'measure': 'Serious arrhythmia', 'timeFrame': 'whole observational period'}, {'measure': 'Hospitalization for the heart failure', 'timeFrame': 'whole observational period'}, {'measure': 'Hospitalization for the unstable angina', 'timeFrame': 'whole observational period'}, {'measure': 'cerebral stroke', 'timeFrame': 'whole observational period'}, {'measure': 'Bone fracture', 'timeFrame': 'whole observational period'}], 'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': 'whole observational period'}, {'measure': 'Myocardial infarction of the new onset', 'timeFrame': 'whole observational period'}], 'secondaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': 'whole observational period'}, {'measure': 'Myocardial infarction of the new onset', 'timeFrame': 'whole observational period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pitavastatin', 'Hemodialysis', 'Mortality', 'Cardiovascular disease'], 'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify whether pitavastatin prevents from cardiovascular events and improves the mortality in chronic hemodialysis patients with hypercholesteremia.', 'detailedDescription': 'It was already proved by the clinical trials that statins prevent from death and cardiovascular events. However, the efficacy of statins in patients with chronic hemodialysis has not been proved yet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients under hemodialysis\n* patients with hypercholesterolemia as defined by any of following parameters:\n\n * LDL-C ≧ 100 mg / dL\n * TC ≧ 180 mg / dL\n * patients required cholesterol-lowering treatment by investigators.\n* patients aged 20-75 years\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 taking statins or fibrates\n* patients enrolled to the other trials using contraindication drugs of pitavastatin\n* patients who had acute myocardial infarction within six months before the day of the agreement acquisition\n* patients scheduled PCI and CABG within six months after the day of the agreement acquisition\n* Patients who had diagnosis or doubt of malignant tumor\n* patients corresponded to "Contraindications" of pitavastatin\n* Familial hypercholesterolemia patients\n* patients judged ineligible by investigators'}, 'identificationModule': {'nctId': 'NCT00846118', 'briefTitle': 'Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis (DIALYSIS)', 'organization': {'class': 'OTHER', 'fullName': 'Juntendo University'}, 'officialTitle': 'Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis.', 'orgStudyIdInfo': {'id': '208-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pitavastatin', 'description': 'Pitavastatin in addition to optimal standard care', 'interventionNames': ['Drug: Pitavastatin']}, {'type': 'NO_INTERVENTION', 'label': 'optimal standard care'}], 'interventions': [{'name': 'Pitavastatin', 'type': 'DRUG', 'otherNames': ['LIVALO'], 'description': '1-4mg/day', 'armGroupLabels': ['Pitavastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113-8421', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Division of Nephrology, Department of Internal Medicine, Juntendo Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Yasuhiko Tomino, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine, Department of Nephrology, Juntendo University Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chieko Hamada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Division of Nehprology', 'investigatorFullName': 'Chieko Hamada', 'investigatorAffiliation': 'Juntendo University'}}}}