Ignite Creation Date:
2025-12-24 @ 11:55 AM
Ignite Modification Date:
2026-01-06 @ 5:35 AM
Study NCT ID:
NCT03446261
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2018-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-21', 'studyFirstSubmitDate': '2018-02-20', 'studyFirstSubmitQcDate': '2018-02-20', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to week 8 in ApoB/ApoA1 ratio', 'timeFrame': 'Baseline, Week 8'}], 'secondaryOutcomes': [{'measure': 'Proportion of over 50% reduction in LDL-C', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Proportion of subjects achieving the comprehensive lipid target (LDL-C<70mg/dL, Non-HDL-C<100mg/dL, and ApoB<80mg/dL)', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Change from baseline to week 8 in total, non-HDL, LDL and HDL cholesterol, triglyceride, ApoB, ApoA1 and ApoB48', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Change from baseline to week 8 in HOMA-IR', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Change from baseline to week 8 in hs-CRP', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Change from baseline to week 8 in HbA1C', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Change from baseline to week 8 in FPG', 'timeFrame': 'Baseline, Week 8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '32065359', 'type': 'DERIVED', 'citation': 'Lee J, Hwang YC, Lee WJ, Won JC, Song KH, Park CY, Ahn KJ, Park JY. Comparison of the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy and Rosuvastatin Monotherapy on Lipoprotein in Patients With Type 2 Diabetes: Multicenter Randomized Controlled Study. Diabetes Ther. 2020 Apr;11(4):859-871. doi: 10.1007/s13300-020-00778-1. Epub 2020 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia', 'detailedDescription': 'This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 5mg/ezetimibe 10mg) vs Monorova® (rosuvastatin 10mg) treated for 8 weeks in Korean patients with type 2 diabetes mellitus and hypercholesterolemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 19 to 70 years\n2. Patient with type 2 diabetes who needs treatment for hypercholesterolemia\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit\n2. Uncontrollable diabetes with HbA1c ≥ 8.5%\n3. Fasting LDL-C ≤ 70 mg/dL\n4. Fasting triglyceride ≥ 400 mg/dL\n5. Total cholesterol ≥ 300 mg/dL\n6. History of muscular disease or rhabdomyolysis due to use of statin\n7. Hypersensitive to rosuvastatin or ezetemibe\n8. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:\n\n ① Severe renal disease (estimated GFR(MDRD) \\< 30mL/min/1.73m2)\n\n ② ALT, AST \\> 3x ULN or history of active liver disease\n\n ③ CPK \\> 3x ULN\n9. Administration of other investigational products within 30 days prior to screening visit\n10. Other than the above who is deemed to be ineligible to participate in the trial by investigator'}, 'identificationModule': {'nctId': 'NCT03446261', 'briefTitle': 'Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'A Randomized, Multicenter, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy vs Rosuvastatin Monotherapy in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'YMC029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvamibe® Tab', 'description': 'Rosuvamibe® Tab (rosuvastatin 5mg/ezetimibe 10mg) qd for 8 weeks', 'interventionNames': ['Drug: Rosuvamibe® Tab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monorova® Tab', 'description': 'Monorova® Tab (rosuvastatin 10mg) qd for 8 weeks', 'interventionNames': ['Drug: Monorova® Tab']}], 'interventions': [{'name': 'Rosuvamibe® Tab', 'type': 'DRUG', 'description': 'Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks', 'armGroupLabels': ['Rosuvamibe® Tab']}, {'name': 'Monorova® Tab', 'type': 'DRUG', 'description': 'Rosuvastatin 10mg qd for 8 weeks', 'armGroupLabels': ['Monorova® Tab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kora-ri', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 36.9091, 'lon': 126.4289}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}