Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT04074551
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2019-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and 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': 'D019808', 'term': 'Losartan'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-26', 'studyFirstSubmitDate': '2019-08-29', 'studyFirstSubmitQcDate': '2019-08-29', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in LDL-C (%)', 'timeFrame': 'baseline, 8 weeks', 'description': 'Experimental, Active Control 1'}, {'measure': 'Change from baseline in sitting systolic blood pressure', 'timeFrame': 'baseline, 8 weeks', 'description': 'Experimental, Active Control 2'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in LDL-C (%)', 'timeFrame': 'baseline, 8 weeks', 'description': 'Experimental, Active Control 2'}, {'measure': 'Change from baseline in sitting systolic blood pressure', 'timeFrame': 'baseline, 8 weeks', 'description': 'Experimental, Active Control 1'}, {'measure': 'Change from baseline in LDL-C (%)', 'timeFrame': 'baseline, 4 weeks'}, {'measure': 'Change from baseline in sitting systolic blood pressure', 'timeFrame': 'baseline, 4 weeks'}, {'measure': 'Change from baseline in TC, HDL-C, TG (%)', 'timeFrame': 'baseline, 4 weeks, 8 weeks'}, {'measure': 'Change from baseline in sitting distolic blood pressure', 'timeFrame': 'baseline, 4 weeks, 8 weeks'}, {'measure': 'Proportion of subject achieving LDL-C control', 'timeFrame': 'baseline, 4 weeks, 8 weeks'}, {'measure': 'Proportion of subjects achieving blood pressure control', 'timeFrame': 'baseline, 4 weeks, 8 weeks'}, {'measure': 'Proportion of responder for blood pressure', 'timeFrame': 'baseline, 4 weeks, 8 weeks'}, {'measure': 'Proportion of subject achieving both LDL-C and blood pressure control', 'timeFrame': 'baseline, 4 weeks, 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Dyslipidemias']}, 'referencesModule': {'references': [{'pmid': '37395974', 'type': 'DERIVED', 'citation': 'Kim MC, Ahn Y, Kim MH, Kim SY, Hong TJ, Rhee MY, Kim SH, Hong SJ, Kim H, Kim W, Chae IH, Kang DH, Kim BK, Kim HS. A Randomized, Multicenter, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Quadruple Combination of Amlodipine, Losartan, Rosuvastatin, and Ezetimibe in Patients with Concomitant Essential Hypertension and Dyslipidemia. Am J Cardiovasc Drugs. 2023 Jul;23(4):441-454. doi: 10.1007/s40256-023-00590-9. Epub 2023 Jul 3.'}]}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 versus HCP1701 in Patients with Hypertension and Dyslipidemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 19\n* Patients who understood the contents and purpose of this trial and signed informed consent form\n* Patients with essential hypertension and dyslipidemia\n\nExclusion Criteria:\n\n* Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP\n* Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg\n* Concomitant administration of cyclosporine\n* Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy\n* Hereditary angioedema or medical history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor blockers\n* Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin\n* CPK normal range \\> 2 times\n* Secondary hypertension and suspected secondary hypertension\n* Orthostatic hypotension with symptoms\n* Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)\n* Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)\n* Active gout or hyperuricemia(uric acid ≥ 9mg/dL)\n* IDDM or uncontrolled type 2 diabetes mellitus (HbA1c \\> 9%)\n* Ventricular arrhythmia\n* Medical history\n\n * Severe heart disease(heart failure of NYHA class III-IV)\n * Severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertensive encephalopathy, transient cerebral ischemic attack(TIA)\n * Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant stenosis in aortic valve or mitral valve\n * Ischemic heart disease(myocardial infarction, angina) within 6months\n * Angioplasty or coronary artery bypass graft(CABG) surgery within 6months'}, 'identificationModule': {'nctId': 'NCT04074551', 'briefTitle': 'A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia', 'orgStudyIdInfo': {'id': 'HM-AMOS-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'HCP1701', 'interventionNames': ['Drug: HCP1701']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator 1', 'description': 'HGP0904, HGP0608', 'interventionNames': ['Drug: Losartan', 'Drug: Amlodipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator 2', 'description': 'HGP0608, HCP1306', 'interventionNames': ['Drug: Losartan', 'Drug: Rosuvastatin and Ezetimibe']}], 'interventions': [{'name': 'HCP1701', 'type': 'DRUG', 'description': 'HCP1701', 'armGroupLabels': ['Experimental']}, {'name': 'Losartan', 'type': 'DRUG', 'description': 'Losartan', 'armGroupLabels': ['Active Comparator 1', 'Active Comparator 2']}, {'name': 'Amlodipine', 'type': 'DRUG', 'description': 'Amlodipine', 'armGroupLabels': ['Active Comparator 1']}, {'name': 'Rosuvastatin and Ezetimibe', 'type': 'DRUG', 'description': 'Rosuvastatin and Ezetimibe', 'armGroupLabels': ['Active Comparator 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': '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': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}