Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04959305
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2021-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 Study to Explore the Dose 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', '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'}, {'measure': 'Proportion of responder', 'timeFrame': 'baseline, 4 weeks, 8 weeks'}, {'measure': 'Change from baseline in pulse pressure(sitSBP - sitDBP)', 'timeFrame': 'baseline, 4 weeks, 8 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '37095689', 'type': 'DERIVED', 'citation': 'Sung KC, Hong SJ, Rhee MY, Jeong MH, Kim DH, Lim SW, Park K, Lee JB, Kim SY, Cho JM, Cho GY, Heo JH, Kim SH, Lee HY, Kim W, Cho DK, Park S, Shin J, Pyun WB, Kwon K, Rha SW, Jung JA. Comparison of efficacy and safety between third-dose triple and third-dose dual antihypertensive combination therapies in patients with hypertension. J Clin Hypertens (Greenwich). 2023 May;25(5):429-439. doi: 10.1111/jch.14656. Epub 2023 Apr 24.'}]}, 'descriptionModule': {'briefSummary': 'A multicenter, randomized, double-blind, parallel, phase 2 study to explore the dose of HCP1803 in patients with essential hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions\n\n * mean sitSBP \\<180 mmHg and mean sitDBP \\< 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1\n * 140 mmHg ≤ mean sitSBP \\< 180 mmHg and mean sitDBP \\< 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1\n2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP \\< 180 mmHg and mean sitDBP \\< 110 mmHg at Visit 2\n\nExclusion Criteria:\n\n1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1\n2. Orthostatic hypotension with symptoms within 3 months prior to visit 1.\n3. Secondary hypertensive patient or suspected to be\n4. Uncontrolled diabetes mellitus(HbA1c \\> 9%) or type I diabetes mellitus\n5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL)\n6. Severe heart disease or severe neurovascular disease\n7. Moderate or malignant retinopathy\n8. Clinically significant hematological finding\n9. Severe renal diseases (eGFR\\<30mL/min/1.73m2)\n10. Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)\n11. Hypokalemia or Hyperkalemia(K\\<3.5mmol/L or K ≥ 5.5mmol/L)\n12. Hyponatremia or Hypernatremia(Na\\<135mmol/L or Na ≥ 155mmol/L)\n13. Hypercalcemia\n14. History of malignancy tumor\n15. History of autoimmune disease\n16. History of alcohol or drug abuse\n17. Positive to pregnancy test, nursing mother, intention on pregnancy\n18. Considered by investigator as not appropriate to participate in the clinical study with other reason'}, 'identificationModule': {'nctId': 'NCT04959305', 'acronym': 'HM_APOLLO', 'briefTitle': 'A Phase 2 Study to Explore the Dose of HCP1803 in Patients With Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Parallel, Phase 2 Study to Explore the Dose of HCP1803 in Patients With Essential Hypertension', 'orgStudyIdInfo': {'id': 'HM-APOLLO-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental 1', 'description': 'HCP1803-3', 'interventionNames': ['Drug: HCP1803-3', 'Drug: HPP2005']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator 1', 'description': 'RLD2003', 'interventionNames': ['Drug: RLD2003', 'Drug: HPP2003-3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator 2', 'description': 'RLD2004', 'interventionNames': ['Drug: RLD2004', 'Drug: HPP2003-3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator 3', 'description': 'RLD2005', 'interventionNames': ['Drug: RLD2005', 'Drug: HPP2003-3']}], 'interventions': [{'name': 'HCP1803-3', 'type': 'DRUG', 'description': 'Take it once daily for 8 weeks orally.', 'armGroupLabels': ['Experimental 1']}, {'name': 'RLD2003', 'type': 'DRUG', 'description': 'Take it once daily for 8 weeks orally.', 'armGroupLabels': ['Active Comparator 1']}, {'name': 'RLD2004', 'type': 'DRUG', 'description': 'Take it once daily for 8 weeks orally.', 'armGroupLabels': ['Active Comparator 2']}, {'name': 'RLD2005', 'type': 'DRUG', 'description': 'Take it once daily for 8 weeks orally.', 'armGroupLabels': ['Active Comparator 3']}, {'name': 'HPP2003-3', 'type': 'DRUG', 'description': 'Placebo drug. Take it once daily for 8 weeks orally.', 'armGroupLabels': ['Active Comparator 1', 'Active Comparator 2', 'Active Comparator 3']}, {'name': 'HPP2005', 'type': 'DRUG', 'description': 'Placebo drug. Take it once daily for 8 weeks orally.', 'armGroupLabels': ['Experimental 1']}]}, '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'}}}}