Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-31 @ 9:22 AM
Study NCT ID:
NCT05660135
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2022-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068557', 'term': 'Olmesartan Medoxomil'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2022-12-13', 'studyFirstSubmitQcDate': '2022-12-13', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of change in LDL-C', 'timeFrame': 'at 24 weeks', 'description': 'The rate of change in LDL-C at 12 weeks from baseline'}, {'measure': 'The amount of change in LDL-C', 'timeFrame': 'at 24 weeks', 'description': 'The amount of change in LDL-C at 24 weeks from baseline'}], 'secondaryOutcomes': [{'measure': 'The rate of change in LDL-C', 'timeFrame': 'at 12 weeks', 'description': 'The rate of change in LDL-C at 12 weeks from baseline'}, {'measure': 'The amount of change in LDL-C', 'timeFrame': 'at 12 weeks', 'description': 'The amount of change in LDL-C at 12 weeks from baseline'}, {'measure': 'The rate of change in SBP(Systolic Blood Pressure)', 'timeFrame': '12 weeks', 'description': 'The rate of change in SBP(Systolic Blood Pressure) at 12 weeks from baseline'}, {'measure': 'The rate of change in SBP(Systolic Blood Pressure)', 'timeFrame': '24 weeks', 'description': 'The rate of change in SBP(Systolic Blood Pressure) at 24 weeks from baseline'}, {'measure': 'The amount of change in SBP(Systolic Blood Pressure)', 'timeFrame': '12 weeks', 'description': 'The amount of change in SBP(Systolic Blood Pressure) at 12 weeks from baseline'}, {'measure': 'The amount of change in SBP(Systolic Blood Pressure)', 'timeFrame': '24 weeks', 'description': 'The amount of change in SBP(Systolic Blood Pressure) at 24 weeks from baseline'}, {'measure': 'The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG)', 'timeFrame': '12 weeks', 'description': 'The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 12 weeks from baseline'}, {'measure': 'The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG)', 'timeFrame': '24 weeks', 'description': 'The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 24 weeks from baseline'}, {'measure': 'The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG)', 'timeFrame': '12 weeks', 'description': 'The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 12 weeks from baseline'}, {'measure': 'The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG)', 'timeFrame': '24 weeks', 'description': 'The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 24 weeks from baseline'}, {'measure': 'Percentage of subjects who reached LDL-C target', 'timeFrame': '12 weeks', 'description': "Percentage of subjects who reached LDL-C target according to Korean Society of Lipid/Arteriosclerosis's risk classification in the guidelines for the treatment of dyslipidemia (2018) at 12 weeks from baseline"}, {'measure': 'Percentage of subjects who reached LDL-C target', 'timeFrame': '24 weeks', 'description': "Percentage of subjects who reached LDL-C target according to Korean Society of Lipid/Arteriosclerosis's risk classification in the guidelines for the treatment of dyslipidemia (2018) at 24 weeks from baseline"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Dyslipidemias']}, 'descriptionModule': {'briefSummary': 'This study is a large-scale, prospective, multi-center, and non-interventional observation study to observe blood pressure and blood lipid changes and safety during administration of olomax tablets for 24 weeks in hypertensive patients with dyslipidemia.', 'detailedDescription': "In this study, investigator will evaluate subjects' clinical performance in actual care. Laboratory test results such as demographic information and medical treatment, blood pressure, blood lipid test, and liver function test conducted at the start date of Olomax tablet administration and subsequent 24 weeks (± 8 weeks) will be collected. In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is to confirm the effect of olomax tablet -reducing blood pressure and LDL-C- in patients with hypertension and dyslipidemia compared to existing drugs . Of the total 4,672,648 statin prescriptions in 2020, about 295,379 were combined prescriptions for hypertension treatment. It was expected that about 1% of them could be registered, and therefore we estimated 4,000 study subjects to be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult aged 19 or older at the time of the baseline visit.\n2. A patient with hypertension and dyslipidemia who is scheduled to administer olomax tablet according to investigator's medical judgement.\n\n * Patients who were previously taking more than two tablets of a single drug, low-density lipoprotein-cholesterol (LDL-C)\n * Patients who were previously only taking blood pressure-lowering drugs and did not take LDL-C-lowering drugs, but who need to take additional LDL-C-lowering drugs at the discretion of the researcher\n * Patients who were previously taking LDL-C lowering agents and did not take blood pressure lowering agents, but who need to take additional blood pressure lowering agents according to the researcher's judgment\n * Patients who have not previously taken both a blood pressure drop and an LDL-C drop but need additional simultaneous use at the discretion of the researcher\n3. A person who can understand the information provided to him/her and may voluntarily sign a written consent form\n\nExclusion Criteria:\n\n1. A person who falls under the prohibition of administration according to the permission for olomax tablet\n2. A person who has a history of administering olomax tablets before participating in this study\n3. In addition to the above, a person that the investigator thinks he/she is not suitable for participating in this observation study;"}, 'identificationModule': {'nctId': 'NCT05660135', 'briefTitle': 'Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia: a Multi-center-database Real-world Study', 'orgStudyIdInfo': {'id': 'DWOLM_RWE02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with hypertension and dislipidemia', 'description': 'received olomax tablet as treatment.', 'interventionNames': ['Drug: Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca']}], 'interventions': [{'name': 'Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca', 'type': 'DRUG', 'description': 'Olomax Tab 20/5/5mg Olomax Tab 20/5/10mg Olomax Tab 40/5/5mg Olomax Tab 40/5/10mg', 'armGroupLabels': ['patients with hypertension and dislipidemia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul ST. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hun-Sung Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Catholic University of Korea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Do not have plan yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}