Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-29 @ 2:33 PM
Study NCT ID:
NCT03872232
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000077333', 'term': 'Telmisartan'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-11', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Low density lipoprotein cholesterol (LDL-C)', 'timeFrame': 'Baseline, Week 8', 'description': 'LDL-C change at Week 8 compared to Baseline'}, {'measure': 'Mean sitting systolic blood pressure (MSSBP)', 'timeFrame': 'Baseline, Week 8', 'description': 'MSSBP change at Week 8 compared to Baseline'}], 'secondaryOutcomes': [{'measure': 'Mean sitting systolic blood pressure (MSSBP)', 'timeFrame': 'Baseline, Week 4', 'description': 'MSSBP change at Week 4 compared to Baseline'}, {'measure': 'Low density lipoprotein cholesterol (LDL-C)', 'timeFrame': 'Baseline, Week 4', 'description': 'LDL-C change at Week 4 compared to Baseline'}, {'measure': 'Mean sitting diastolic blood pressure (MSDBP)', 'timeFrame': 'Baseline, Week 4, Week 8', 'description': 'MSDBP change at Week 4, 8 compared to Baseline'}, {'measure': 'Total Cholesterol (TC)', 'timeFrame': 'Baseline, Week 4, Week 8', 'description': 'TC change at Week 4, 8 compared to Baseline'}, {'measure': 'High density lipoprotein cholesterol (HDL-C)', 'timeFrame': 'Baseline, Week 4, Week 8', 'description': 'HDL-C change at Week 4, 8 compared to Baseline'}, {'measure': 'Triglyceride (TG)', 'timeFrame': 'Baseline, Week 4, Week 8', 'description': 'TG change at Week 4, 8 compared to Baseline'}, {'measure': 'Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)', 'timeFrame': 'Baseline, Week 4, Week 8', 'description': 'LDL-C/HDL-C change at Week 4, 8 compared to Baseline'}, {'measure': 'Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)', 'timeFrame': 'Baseline, Week 4, Week 8', 'description': 'TC/HDL-C change at Week 4,8 compared to Baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension.', 'detailedDescription': 'This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension.\n\nIn "Rosuvastatin/Ezetimibe+Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.\n\nIn "Rosuvastatin/Ezetimibe" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe" for 8 weeks.\n\nIn "Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Telmisartan" for 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Subjects with hypertension and hyperlipidemia\n\nExclusion Criteria:\n\n* Patient with known or suspected secondary hypertension\n* Other exclusions applied'}, 'identificationModule': {'nctId': 'NCT03872232', 'briefTitle': 'Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Addpharma Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan in Patients With Primary Hypercholesterolemia and Essential Hypertension', 'orgStudyIdInfo': {'id': 'ROZETEL_RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ezetimibe/Rosuvastatin and Telmisartan', 'description': '60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin and Telmisartan" for 8 weeks.', 'interventionNames': ['Drug: Ezetimibe/Rosuvastatin', 'Drug: Telmisartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ezetimibe/Rosuvastatin', 'description': '60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin" for 8 weeks.', 'interventionNames': ['Drug: Ezetimibe/Rosuvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telmisartan', 'description': '60 subjects will be assigned and the subjects will be administered "Telmisartan" for 8 weeks.', 'interventionNames': ['Drug: Telmisartan']}], 'interventions': [{'name': 'Ezetimibe/Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Rosuvamibe Tab.'], 'description': 'PO, Once daily(QD), 8weeks', 'armGroupLabels': ['Ezetimibe/Rosuvastatin', 'Ezetimibe/Rosuvastatin and Telmisartan']}, {'name': 'Telmisartan', 'type': 'DRUG', 'otherNames': ['Micardis Tab.'], 'description': 'PO, Once daily(QD), 8weeks', 'armGroupLabels': ['Ezetimibe/Rosuvastatin and Telmisartan', 'Telmisartan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyo Soo Kim, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addpharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}