Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-01 @ 9:12 PM
Study NCT ID:
NCT06955104
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2025-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients With Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'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': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from baseline in LDL-C', 'timeFrame': 'Week 8', 'description': 'Check LDL-C'}], 'secondaryOutcomes': [{'measure': 'Efficacy and Safety: Change from baseline in LDL-C (mg/dL)', 'timeFrame': 'Week 8', 'description': 'Check LDL-C'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients with Dyslipidemia', 'detailedDescription': 'To evaluate the efficacy and safety of JW0108+C2407 in dyslipidemia patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 19 years old at the time of written informed consent\n* Patients with dyslipidemia\n\nExclusion Criteria:\n\n* Secondary dyslipidemia\n* Patient who does not meet the specified TG, LDL-C level'}, 'identificationModule': {'nctId': 'NCT06955104', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients With Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'JW Pharmaceutical'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients With Dyslipidemia', 'orgStudyIdInfo': {'id': 'JW24302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group: JW0108 + C2407', 'description': 'For 8weeks QD(Quaque Die)', 'interventionNames': ['Drug: JW0108 + C2407']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group: JW0108 + C2407 placebo', 'description': 'For 8weeks QD(Quaque Die)', 'interventionNames': ['Drug: JW0108 + C2407 placebo']}], 'interventions': [{'name': 'JW0108 + C2407', 'type': 'DRUG', 'description': 'JW0108 + C2407', 'armGroupLabels': ['Experimental Group: JW0108 + C2407']}, {'name': 'JW0108 + C2407 placebo', 'type': 'DRUG', 'description': 'JW0108 + C2407 placebo', 'armGroupLabels': ['Control Group: JW0108 + C2407 placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JW Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}