Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT06121518
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2023-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C482243', 'term': '2-(3,4-dimethoxyphenyl)-8-(4-hydroxy-3-methoxyphenyl)-6-methyl-2-isopropyl-6-azaoctanitrile'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 235}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2023-10-24', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in MSSBP(mean sitting SBP(systolic blood pressure))', 'timeFrame': '8 weeks', 'description': 'Compare experimental group with comparator group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients', 'detailedDescription': 'This study is a Randomized, Double-blind, Multi-center, Therapeutic confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects who are 19 years old or older.\n2. Subjects who are mean blood pressure measured in the arm selected as the reference arm meets the following criteria:\n\n * Didn't take antihypertensive drug\n\n * 140 mmHg ≤ MSSBP(mean sitting SBP) \\< 180 mmHg\n * Taking antihypertensive drug\n\n * 130 mmHg ≤ MSSBP(mean sitting SBP) \\< 180 mmHg\n3. Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.\n\nExclusion Criteria:\n\n1. Subjects with a history of secondary hypertension or suspected secondary hypertension\n2. Subjects with symptomatic orthostatic hypotension\n3. Subjects with type 1 diabetes or diabetes that is not adequately controlled (HbA1c \\> 9.0%)\n4. Subjects with Severe heart failure(NYHA Class 3,4) etc.,\n5. Subjects with a history of unstable angina, moderate or malignant retinopathy, etc., within 6 months at the time of screening\n6. Subjects with a history of disability to investigational product ADME at the time of screening\n7. Subjects with abnormalities in laboratory test results at the time of screening\n8. Subjects with hypersensitivity or history of investigational product and similar drugs\n9. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period\n10. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening\n11. Subjects who received other investigational product within 4 weeks of screening visit\n12. Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last investigational product\n13. Subjects who are unable to participate in this clinical trial at the discretion of the investigator"}, 'identificationModule': {'nctId': 'NCT06121518', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients', 'orgStudyIdInfo': {'id': 'A30_17HT2222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'D064 and D702 Combination Therapy', 'interventionNames': ['Drug: D064 and D702, QD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator Group 1', 'description': 'D064 Monotherapy', 'interventionNames': ['Drug: D064 and Placebo of D702, QD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator Group 2', 'description': 'D702 Monotherapy', 'interventionNames': ['Drug: Placebo of D064 and D702, QD']}], 'interventions': [{'name': 'D064 and D702, QD', 'type': 'DRUG', 'otherNames': ['D064 and D702 Combination Therapy'], 'description': 'Experimental Group Subjects assigned to this group are treated with D064, D702', 'armGroupLabels': ['Experimental Group']}, {'name': 'D064 and Placebo of D702, QD', 'type': 'DRUG', 'otherNames': ['D064 Monotherapy'], 'description': 'Comparator Group Subjects assigned to this group are treated with D064, placebo of D702', 'armGroupLabels': ['Comparator Group 1']}, {'name': 'Placebo of D064 and D702, QD', 'type': 'DRUG', 'otherNames': ['D702 Monotherapy'], 'description': 'Comparator Group Subjects assigned to this group are treated with D702, placebo of D064', 'armGroupLabels': ['Comparator Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04763', 'city': 'Seoul', 'state': 'Seongdong-gu', 'country': 'South Korea', 'facility': 'Hanyang University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jinho Shin, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University Seoul Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}