Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT03403556
Status:
UNKNOWN
Last Update Posted:
2020-12-14
First Post:
2017-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2017-12-11', 'studyFirstSubmitQcDate': '2018-01-10', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean percent change from baseline to week 24 in low-density lipoprotein cholesterol (LDL-C)', 'timeFrame': 'Up to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects achieving < 7.5% 10-year ASCVD risk without withdrawn due to adverse events', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Mean change from baseline to week 12 and to week 24 in 10-year ASCVD risk', 'timeFrame': 'Up to 12 weeks, Up to 24 weeks'}, {'measure': 'Proportion of subjects achieving the comprehensive lipid target (LDL-C < 70mg/dL, Non-HDL-C < 100mg/dL, and Apolipoprotein B < 80mg/dL) without withdrawn due to adverse events', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Mean change from baseline to week 24 in calculated LDL cholesterol(mg/dL), HDL cholesterol(mg/dL), Triglyceride(mg/dL), non-HDL cholesterol(mg/dL), Apolipoprotein B(mg/dL), Apolipoprotein A1(mg/dL)', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Mean change from baseline to week 24 in Hepatic Steatosis Index (HSI)', 'timeFrame': 'Up to 24 weeks', 'description': 'hepatic steatosis index (HSI)= 8x(ALT/AST ratio)+BMI (+2, if female; +2, if diabetes mellitus)'}, {'measure': 'Mean change from baseline to week 24 in Fatty Liver Index (FLI)', 'timeFrame': 'Up to 24 weeks', 'description': 'FLI scores will be calculated based on triglycerides, BMI, r-GT and Waist circumference. BMI(kg/m\\^2) will be calculated based on height(m) and weight(kg).'}, {'measure': 'Mean change from baseline to week 24 in non-alcoholic fatty liver disease liver fat score (NAFLD-LFS)', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Mean change from baseline to week 24 in HbA1c', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Mean change from baseline to week 24 in fasting plasma glucose (FPG)', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Mean change from baseline to week 24 in sCD36', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Mean change from baseline to week 24 in HOMA-IR', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Mean change from baseline to week 24 in HOMA-B', 'timeFrame': 'Up to 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High ASCVD risk patients with type 2 diabetes'], 'conditions': ['Atherosclerotic Cardiovascular Disease', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of moderate-intensity rosuvastatin/ezetimibe compared to high-intensity rosuvastatin in high atherosclerotic cardiovascular disease risk patients with type 2 diabetes', 'detailedDescription': 'This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 10mg/ezetimibe 10mg) vs. rosuvastatin 20mg treated for 24 weeks in atherosclerotic cardiovascular disease risk (≥ 7.5%) patients with type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* ≥ 40 and \\< 75 years of age at the time of informed consent\n* Estimated 10-year ASCVD (atherosclerotic cardiovascular disease) risk ≥ 7.5% with type 2 diabetes according to the American Diabetes Association criteria in screening\n* HbA1c ≥ 6% and \\< 10% in screening\n* Body mass index (BMI) ≤ 35kg/m2 in screening\n* Female of childbearing with a negative pregnancy test who must agree to use contraception (including those not medically pregnant) during the study period\n* Written consent after being informed of the purpose and contents of the clinical trial and the characteristics and risks of IPs\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Chronic hepatitis B or chronic hepatitis C, severe hepatic dysfunction (AST, ALT, ALP or CPK ≥ 3 x ULN) in screening\n* Heavy drinking \\> 210g per week in screening\n* Estimated GFR \\< 30mL/min/1.73m2 using the CKD-EPI formula in screening\n* Undergoing renal replacement therapy (hemodialysis or peritoneal dialysis) in screening\n* Having used other statin (HMG-CoA converting enzyme inhibitors) than Rosuvastatin or fibrate drugs in the last 3 months before screening\n* Taking any medication (ex. Fenofibrate, Omega 3 fatty acid, etc.) that may affect LDL\n\n \\* Can be enrolled after 4 week-washout\n* Having used thiazolidinedione drugs in the last 3 months before screening\n* Taking cyclosporine concomitantly\n* Positive HIV test in screening\n* Pregnant, breastfeeding, or childbearing women who are not likely to use the appropriate contraceptive methods as judged by investigator\n* Subjects with a medical history of myopathy and rhabdomyolysis due to use of statin\n* Hypersensitive to statin and ezetimibe\n* Having endocrine or metabolic disease known to affect serum lipids or lipoproteins\n\n * Uncontrolled diabetes (HbA1c ≥ 10%)\n * Uncontrolled thyroid dysfunction (TSH ≥ 3 x ULN)\n* Subjects with a medical history of acute arterial diseases such as unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft or percutaneous coronary intervention in the last 6 months before screening\n* Subjects with a surgical history of gastrointestine or drug absorption disorders due to gastrointestinal disorders\n* Insulin-treated\n* Taking other IPs in the last 30 days before screening\n* Subjects who cannot discontinue contraindications that may affect the treatment of all types of diabetes and/or hypercholesterolemia during the study period\n* Subjects with a significant or unstable medical or psychological condition that is judged by investigator to be detrimental to safety or to successful participation in the trial\n* Other conditions than the above who is deemed to be ineligible to participate in the trial by investigator'}, 'identificationModule': {'nctId': 'NCT03403556', 'briefTitle': 'High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'A Randomized, Multicenter, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety Between High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in High ASCVD Risk Patients With Type 2 diabEtes (CREATE Study)', 'orgStudyIdInfo': {'id': 'CREATE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvamibe ® Tab.', 'description': 'Rosuvastatin 10mg/Ezetimibe10mg', 'interventionNames': ['Drug: Rosuvamibe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monorova ® Tab.', 'description': 'Rosuvastatin 20mg', 'interventionNames': ['Drug: Monorova']}], 'interventions': [{'name': 'Rosuvamibe', 'type': 'DRUG', 'description': 'Rosuvastatin 10mg/Ezetimibe10mg qd for 24 weeks', 'armGroupLabels': ['Rosuvamibe ® Tab.']}, {'name': 'Monorova', 'type': 'DRUG', 'description': 'Rosuvastatin 20mg qd for 24 weeks', 'armGroupLabels': ['Monorova ® Tab.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daegu', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyuchang Won', 'role': 'CONTACT', 'email': 'kcwon@med.yu.ac.kr', 'phone': '53-620-3846', 'phoneExt': '82'}], 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Gyeonggi-do', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': "The Catholic University of Korea, St. Vincent's Hospital", 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}