Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT02940366
Status:
UNKNOWN
Last Update Posted:
2017-02-09
First Post:
2016-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of High-dose Pitavastatin on Glucose Control in Patients With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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'}]}, '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': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2016-10-19', 'studyFirstSubmitQcDate': '2016-10-19', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change in HbA1c level', 'timeFrame': 'baselina and after 24months treatment'}]}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '29078817', 'type': 'DERIVED', 'citation': 'Park JB, Jung JH, Yoon YE, Kim HL, Lee SP, Kim HK, Kim YJ, Cho GY, Sohn DW. Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial. Trials. 2017 Oct 27;18(1):501. doi: 10.1186/s13063-017-2229-4.'}]}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control in patients with metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed as metabolic syndrome according to National cholesterol Education Program criteria\n* Patients with hypercholesterolemia who required to start statin therapy\n\nExclusion Criteria:\n\n* overt diabetes\n* acute coronary syndrome within 2 months\n* acute cerebrovascular event within 2 months\n* recent treatment of statin within 1month\n* recent diagnosed neoplasm\n* recent diagnosed liver disease\n* chronic kidney disease\n* patients with myopathy\n* pregnant women, nursing mothers, women with possibility of pregnant\n* patients being adminstered cyclosporine\n* patients with genetic disease such as galactose intolerance, lactose intolerance, glucose-galactose malabsorption\n* patients with treatment cyclosporin'}, 'identificationModule': {'nctId': 'NCT02940366', 'briefTitle': 'Effect of High-dose Pitavastatin on Glucose Control in Patients With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'the Long-term Effects of High-doSe pitavaStatin on Diabetogenicity in Comparison With Atorvastatin in Patients With Metabolic Syndrome (LESS-DM) Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '1406-027-584'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pitavastatin 4 mg orally daily', 'interventionNames': ['Drug: Pitavastatin 4 mg orally daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Atorvastatin 20 mg orally daily', 'interventionNames': ['Drug: Atorvastatin 20 mg orally daily']}], 'interventions': [{'name': 'Pitavastatin 4 mg orally daily', 'type': 'DRUG', 'description': 'Pitavastatin 4 mg orally daily for 24months', 'armGroupLabels': ['Pitavastatin 4 mg orally daily']}, {'name': 'Atorvastatin 20 mg orally daily', 'type': 'DRUG', 'description': 'Atorvastatin 20 mg orally daily for 24months', 'armGroupLabels': ['Atorvastatin 20 mg orally daily']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyung-Kwan Kim, MD', 'role': 'CONTACT', 'email': 'cardiman73@gmail.com', 'phone': '82-2-2072-0243'}, {'name': 'Hyung-Kwan Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'JW Pharmaceutical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Division of Cardiology, Clinical Professor', 'investigatorFullName': 'Hyung-Kwan Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}