Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06153433
Status:
UNKNOWN
Last Update Posted:
2023-12-01
First Post:
2023-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2023-11-22', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in LDL-C level from Baseline after treatment of each formulation for 8 week', 'timeFrame': 'Week 0, 8, 16'}], 'secondaryOutcomes': [{'measure': 'Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week', 'timeFrame': 'Week 0, 8, 16'}, {'measure': 'Change in High-density lipoprotein (HDL) from Baseline after treatment of each formulation for 8 week', 'timeFrame': 'Week 0, 8, 16'}, {'measure': 'Change in Triglycerides (TG) from Baseline after treatment of each formulation for 8 week', 'timeFrame': 'Week 0, 8, 16'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dyslipidemia', 'orally disintegrating tablet', 'odt', 'rosuvastatin', 'preference'], 'conditions': ['Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '11524058', 'type': 'BACKGROUND', 'citation': 'Olsson AG, Pears J, McKellar J, Mizan J, Raza A. Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia. Am J Cardiol. 2001 Sep 1;88(5):504-8. doi: 10.1016/s0002-9149(01)01727-1.'}, {'pmid': '30483816', 'type': 'BACKGROUND', 'citation': 'Zhang L, Zhang S, Yu Y, Jiang H, Ge J. Efficacy and safety of rosuvastatin vs. atorvastatin in lowering LDL cholesterol : A meta-analysis of trials with East Asian populations. Herz. 2020 Sep;45(6):594-602. doi: 10.1007/s00059-018-4767-2. Epub 2018 Nov 27.'}, {'pmid': '20195400', 'type': 'BACKGROUND', 'citation': 'Park JS, Kim YJ, Choi JY, Kim YN, Hong TJ, Kim DS, Kim KY, Jeong MH, Chae JK, Oh SK, Seong IW. Comparative study of low doses of rosuvastatin and atorvastatin on lipid and glycemic control in patients with metabolic syndrome and hypercholesterolemia. Korean J Intern Med. 2010 Mar;25(1):27-35. doi: 10.3904/kjim.2010.25.1.27. Epub 2010 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia.', 'detailedDescription': "STUDY OBJECTIVES: The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia. Also, this study is designed to observe patients' preference and adherence for SUVARO®ODT.\n\nHYPOTHESIS: We hypothesized that there will be no difference in LDL-C lowering efficacy of the two formulations (SUVARO®ODT 10-mg or rosuvastatin Immediate-release tablet (IR) 10-mg).\n\nSTUDY DESIGN: This is a randomized, multicenter, open-label, two-period crossover study with 112 enrolled patients.\n\nSubjects: Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months\n2. Written informed consent to participate in the trial\n\nExclusion Criteria:\n\n1. History of previous hypersensitivity reaction to other statins, including rosuvastatin\n2. patients with acute arterial disease within 3 months\n3. Uncontrolled Hypertensive Patients defined as SBP ≥180 mm Hg and DBP ≥110 mm Hg, respectively\n4. Uncontrolled diabetes mellitus (HbA1c \\> 9%)\n5. Uncontrolled hypothyroidism defined as TSH \\>1.5 within the last 6 months\n6. Taking other lipid lowering agent except statins\n7. History of statin-induced myopathy, rhabdomyolysis\n8. Patients with severe hepatic or renal dysfunction\n9. BMI (body mass index) \\> 40 kg/m2\n10. history of galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption'}, 'identificationModule': {'nctId': 'NCT06153433', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia', 'orgStudyIdInfo': {'id': '4-2023-0589'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin IR Tablet', 'description': 'Rosuvastatin Immediate-Release Tablet (IRT) 10mg', 'interventionNames': ['Drug: Rosuvastatin Immediate-Release Tablet (IRT) 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'SUVARO®OD Tablet', 'description': 'Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg', 'interventionNames': ['Drug: Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg']}], 'interventions': [{'name': 'Rosuvastatin Immediate-Release Tablet (IRT) 10mg', 'type': 'DRUG', 'description': 'Rosuvastatin Immediate-Release Tablet (IRT) 10mg', 'armGroupLabels': ['Rosuvastatin IR Tablet']}, {'name': 'Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg', 'type': 'DRUG', 'description': 'Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg', 'armGroupLabels': ['SUVARO®OD Tablet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung-Sun Kim', 'role': 'CONTACT', 'email': 'kjs1218@yuhs.ac', 'phone': '+82-2-2228-8457'}], 'facility': 'Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity,', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jung-Sun Kim', 'role': 'CONTACT', 'email': 'kjs1218@yuhs.ac', 'phone': '+82-2-2228-8457'}], 'overallOfficials': [{'name': 'Jung-Sun Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}