Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-02-27 @ 7:06 PM
Study NCT ID:
NCT05400395
Status:
UNKNOWN
Last Update Posted:
2022-10-27
First Post:
2022-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial for GNX80 in Intermittent Claudication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2022-05-27', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking Distance in comparison with the findings from at baseline', 'timeFrame': '24 weeks', 'description': 'walking distance evaluated by a constant treadmill test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intermittent Claudication']}, 'descriptionModule': {'briefSummary': 'This is a Phase 4, randomized clinical trial to evaluate whether GNX80 vs. placebo, prescribed for 6 months to patients with Intermittent Claudication(IC) would lead to an improvement in the walking distance.', 'detailedDescription': 'A Prospective, Randomized, Placebo-controlled, Double-blinded, Multi-center, Phase IV, Exploratory Clinical Trial to Demonstrate the Effect of Improving the Walking Distance by GNX80 in Patients with Intermittent Claudication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of at least 20 years\n* Angiographically confirmed peripheral arterial disease\n* Intermittent claudication for more than 6 months\n\nExclusion Criteria:\n\n* Severe impairment of heart, liver, or kidney function\n* Limitation of walking ability due to respiratory insufficiency or to an orthopaedic condition\n* Poorly controlled diabetes mellitus\n* Positive pregnancy test\n* Planned surgical or endovascular procedures other than for the treatment of IC'}, 'identificationModule': {'nctId': 'NCT05400395', 'briefTitle': 'Clinical Trial for GNX80 in Intermittent Claudication', 'organization': {'class': 'INDUSTRY', 'fullName': 'SK Chemicals Co., Ltd.'}, 'officialTitle': 'A Prospective, Randomized, Placebo-controlled, Double-blinded, Multi-center, Phase IV, Exploratory Clinical Trial to Demonstrate the Effect of Improving the Walking Distance by GNX80 in Patients With Intermittent Claudication', 'orgStudyIdInfo': {'id': 'GNX_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GNX', 'description': 'GNX / 80mg / BID / PO', 'interventionNames': ['Drug: GNX80']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo / BID / PO', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GNX80', 'type': 'DRUG', 'otherNames': ['Test'], 'description': 'GNX80 oral intake(BID) for 24 weeks', 'armGroupLabels': ['GNX']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Control'], 'description': 'Placebo oral intake(BID) for 24 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Woon Rha', 'role': 'CONTACT'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sujin Kim', 'role': 'CONTACT', 'email': 'sujinkim@sk.com', 'phone': '82-2-2008-2938'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}