Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:38 AM
Study NCT ID:
NCT06717360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-05
First Post:
2024-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-C level', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients with Primary Hypercholesterolemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 19-80\n* Patients with primary hypercholesterolemia\n* Those who voluntarily written consent to participate in this clinical trial\n\nExclusion Criteria:\n\n* The subject not meet the specified LDL-C level\n* Other exclusions applied'}, 'identificationModule': {'nctId': 'NCT06717360', 'briefTitle': 'A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ahn-Gook Pharmaceuticals Co.,Ltd'}, 'officialTitle': 'A Multicenter, Randomized, Double-blinded, Active-controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients with Primary Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'AG2304 P3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AG2304T', 'interventionNames': ['Drug: AG2304T']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AG2304R', 'interventionNames': ['Drug: AG2304R']}], 'interventions': [{'name': 'AG2304T', 'type': 'DRUG', 'description': 'AG2304T, QD, PO', 'armGroupLabels': ['AG2304T']}, {'name': 'AG2304R', 'type': 'DRUG', 'description': 'AG2304R, QD, PO', 'armGroupLabels': ['AG2304R']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Soyeon Jeong', 'role': 'CONTACT', 'email': 'soyoun1628@ahn-gook.com', 'phone': '+82-2-3289-4359'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahn-Gook Pharmaceuticals Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}