Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT02916602
Status:
COMPLETED
Last Update Posted:
2016-10-20
First Post:
2016-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605
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'}, {'id': 'D002752', 'term': 'Chlorthalidone'}, {'id': 'C000710253', 'term': 'amlodipine-losartan drug combination'}], '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'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D007094', 'term': 'Imides'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-19', 'studyFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in sitting systolic blood pressure at week 8', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in sitting diastolic blood pressure at week 2 and week 8', 'timeFrame': '2 weeks and 8 weeks'}, {'measure': 'Change from baseline in sitting systolic blood pressure at week 2', 'timeFrame': '2 weeks'}, {'measure': 'Proportion of subjects achieving Blood Pressure control', 'timeFrame': '2 weeks and 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '28939406', 'type': 'DERIVED', 'citation': 'Hong SJ, Jeong HS, Han SH, Chang KY, Hong BK, Lee BK, Chae SC, Kim WS, Park CG, Heo JH, Lee SU, Kim YD, Kim KS, Choi JH, Kang HJ, Kim JJ, Kang SM, Choi YJ, Shin JH, Chun KJ, Shin DG, Park SH, Kwan J, Choi YJ, Jeong MH, Chae JK, Kim DW, Cho JR, Han KR, Won KH, Park SH, Lee SK, Kim SH, Jung J, Kim CH. Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study. Clin Ther. 2017 Oct;39(10):2049-2060. doi: 10.1016/j.clinthera.2017.08.013. Epub 2017 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'A phase 3 study to evaluate efficacy and safety of HCP1401', 'detailedDescription': 'A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Hypertension patient who satisfied below condition at Visit 1.\n\n * patient who takes antihypertensive drug\n\n * 140mmHg \\<= sitSBP \\<= 200mmHg\n * patient who doesn't take antihypertensive drug\n\n * 160mmHg \\<= sitSBP \\<= 200mmHg\n * 140mmHg \\<= sitSBP \\<= 200mmHg at Visit 2\n\nExclusion Criteria:\n\n* Patient who have received 4 or more antihypertensive drug\n* Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1\n* Patient with sitDBP \\>= 120mmHg at Visit 2\n* Patient with secondary hypertension"}, 'identificationModule': {'nctId': 'NCT02916602', 'briefTitle': 'A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605', 'orgStudyIdInfo': {'id': 'HM-ALCH-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'HCP1401', 'interventionNames': ['Drug: HCP1401']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'description': 'HCP0605', 'interventionNames': ['Drug: HCP0605']}], 'interventions': [{'name': 'HCP1401', 'type': 'DRUG', 'otherNames': ['amlodipine, Losartan, Chlorthalidone'], 'description': 'amlodipine, Losartan, Chlorthalidone FDC', 'armGroupLabels': ['Treatment']}, {'name': 'HCP0605', 'type': 'DRUG', 'otherNames': ['amlodipine, Losartan'], 'description': 'amlodipine, Losartan FDC', 'armGroupLabels': ['Reference']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Cheulho Kim, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}