Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-17 @ 12:20 AM
Study NCT ID:
NCT05526703
Status:
UNKNOWN
Last Update Posted:
2022-11-28
First Post:
2022-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-25', 'studyFirstSubmitDate': '2022-08-31', 'studyFirstSubmitQcDate': '2022-08-31', 'lastUpdatePostDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in MSSBP', 'timeFrame': '8 weeks after drug administrations', 'description': 'Compare experimental group with comparator group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy.'}, '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 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 who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period\n3. Subjects with hypersensitivity or history of clinical trial drugs and similar drugs\n4. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period\n5. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening\n6. Subjects who received other clinical trial drugs within 4 weeks of screening visit.\n7. 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 clinical trial drug\n8. Subjects who are unable to participate in this clinical trial at the discretion of the investigator.'}, 'identificationModule': {'nctId': 'NCT05526703', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy', '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 D701 Combination Therapy in Essential Hypertension Subjects Inadequately Controlled by D064 Monotherapy', 'orgStudyIdInfo': {'id': 'A30_14HT2209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'interventionNames': ['Drug: D064, D701, placebo of D012']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator Group', 'interventionNames': ['Drug: D012, placebo of D064, placebo of D701']}], 'interventions': [{'name': 'D064, D701, placebo of D012', 'type': 'DRUG', 'otherNames': ['D064, D701 are consisted of antihypertensive agent.'], 'description': 'Experimental Group Subjects assigned to this group are treated with D064, D701, placebo of D012', 'armGroupLabels': ['Experimental Group']}, {'name': 'D012, placebo of D064, placebo of D701', 'type': 'DRUG', 'otherNames': ['D012 is consisted of antihypertensive agent.'], 'description': 'Comparator Group Subjects assigned to this group are treated with D012, placebo of D064, placebo of D701', 'armGroupLabels': ['Comparator Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ASI|KR|KS013|SEOUL', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung Hyuk Choi', 'role': 'CONTACT'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yeonhwa Park, Project Leader', 'role': 'CONTACT', 'email': 'yeonhwa@ckdpharm.com', 'phone': '82-2-6373-0636'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}