Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
Study NCT ID:
NCT03897868
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2019-03-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2019-03-29', 'studyFirstSubmitQcDate': '2019-03-29', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in sitting systolic blood pressure', 'timeFrame': 'baseline, 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in sitting systolic blood pressure', 'timeFrame': 'baseline, 4 weeks'}, {'measure': 'Change from baseline in sitting distolic blood pressure', 'timeFrame': 'baseline, 4 weeks, 8 weeks'}, {'measure': 'Proportion of subjects achieving blood pressure control', 'timeFrame': '4 weeks, 8 weeks', 'description': 'sitSBP/sitDBP \\< 140/90 mmHg'}, {'measure': 'Proportion of responder', 'timeFrame': 'baseline, 4 weeks, 8 weeks', 'description': 'Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg'}, {'measure': 'Change from baseline in pulse pressure(sitSBP - sitDBP)', 'timeFrame': 'baseline, 4 weeks, 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '33408462', 'type': 'DERIVED', 'citation': 'Hong SJ, Sung KC, Lim SW, Kim SY, Kim W, Shin J, Park S, Kim HY, Rhee MY; HM_APOLLO Investigators. Low-Dose Triple Antihypertensive Combination Therapy in Patients with Hypertension: A Randomized, Double-Blind, Phase II Study. Drug Des Devel Ther. 2020 Dec 31;14:5735-5746. doi: 10.2147/DDDT.S286586. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP \\< 180 mmHg and mean sitDBP \\< 110 mmHg at Visit 1, Visit 2\n\nExclusion Criteria:\n\n* Patient with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1\n* Patient with difference of ≥ 15 mmHg in mean sitSBP between Visit 1 and Visit 2\n* Patient with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg at Visit 1, Visit 2\n* Patient with secondary hypertension'}, 'identificationModule': {'nctId': 'NCT03897868', 'acronym': 'HM_APOLLO', 'briefTitle': 'A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension', 'orgStudyIdInfo': {'id': 'HM-APOLLO-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental 1', 'description': 'HCP1803 High', 'interventionNames': ['Drug: HCP1803', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental 2', 'description': 'HCP1803 Middle', 'interventionNames': ['Drug: HCP1803', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental 3', 'description': 'HCP1803 Low', 'interventionNames': ['Drug: HCP1803', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator 1', 'description': 'HGP0904 High', 'interventionNames': ['Drug: Amlodipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator 2', 'description': 'HGP0904 Low', 'interventionNames': ['Drug: Amlodipine', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator 3', 'description': 'HGP0608', 'interventionNames': ['Drug: Losartan', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HCP1803', 'type': 'DRUG', 'description': 'HCP1803', 'armGroupLabels': ['Experimental 1', 'Experimental 2', 'Experimental 3']}, {'name': 'Amlodipine', 'type': 'DRUG', 'description': 'Amlodipine', 'armGroupLabels': ['Active Comparator 1', 'Active Comparator 2']}, {'name': 'Losartan', 'type': 'DRUG', 'description': 'Losartan', 'armGroupLabels': ['Active Comparator 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Active Comparator 2', 'Active Comparator 3', 'Experimental 1', 'Experimental 2', 'Experimental 3', 'Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10326', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Donggguk University Ilsan Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'overallOfficials': [{'name': 'Moo-Yong Rhee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Donggguk University Ilsan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}