Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT06886620
Status:
TERMINATED
Last Update Posted:
2025-03-20
First Post:
2025-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'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'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077407', 'term': 'Cilostazol'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, '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': 14}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric mean percent change in initial claudication distance (ICD)', 'timeFrame': 'At baseline (day 0) and week 24', 'description': 'The standardized workload treadmill test will be conducted for evaluation of walking performance.\n\nICD is defined as the distance walked to the point of the onset of claudication symptoms.'}], 'secondaryOutcomes': [{'measure': 'Geometric mean percent change in initial claudication distance (ICD)', 'timeFrame': 'At baseline (day 0) and week 12', 'description': 'The standardized workload treadmill test will be conducted for evaluation of walking performance.\n\nICD is defined as the distance walked to the point of the onset of claudication symptoms.'}, {'measure': 'Geometric mean percent change in absolute claudication distance (ACD)', 'timeFrame': 'At baseline (day 0) and week 12', 'description': 'The standardized workload treadmill test will be conducted for evaluation of walking performance.\n\nACD is defined as the maximal distance walked to the point where severe claudication pain forced cessation of exercise.'}, {'measure': 'Geometric mean percent change in absolute claudication distance (ACD)', 'timeFrame': 'At baseline (day 0) and week 24', 'description': 'The standardized workload treadmill test will be conducted for evaluation of walking performance.\n\nACD is defined as the maximal distance walked to the point where severe claudication pain forced cessation of exercise.'}, {'measure': 'Subject assessment of treatment response', 'timeFrame': 'At week 24', 'description': 'Participants will subjectively evaluate the treatment response of study drug on claudication symptoms which will be categorized into:\n\n* Much Better\n* Better\n* Unchanged\n* Worse\n* Much Worse\n\nParticipants rating their improvement on claudication symptoms as "Much Better" or "Better" are classified as responders.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Peripheral Arterial Disease', 'Ankle Brachial Index', 'Absolute Claudication Distance', 'Initial Claudication Distance', 'PMR', 'Cilostazol'], 'conditions': ['Intermittent Claudication']}, 'descriptionModule': {'briefSummary': 'The study is designed to compare the efficacy and safety of once daily PMR treatment with twice daily Pletaal® treatment in patients with intermittent claudication caused by peripheral arterial disease and are currently treated with cilostazol of any strength and any dosing frequency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n* Stable use of Cilostazol of any strength and any dosing frequency for at least 3 months prior to screening, for the treatment of peripheral arterial disease.\n* Initial claudication distance ≥ 30 meters at the constant workload treadmill test.\n\nMain Exclusion Criteria:\n\n* Presence of limb-threatening chronic limb ischemia, manifested by ischemic rest pain, ulceration or gangrene.\n* History of lower-extremity surgical or endovascular arterial reconstructions or sympathectomy within 3 months prior to screening.\n* Presence of illness(es) (such as angina pectoris, respiratory disease, orthopaedic disease, or neurological disorders, except the study disease) limiting the exercise capacity.\n* Presence of uncontrolled hypertension (based on physician's judgment) or other unstable cardiovascular disease such as congestive heart failure of any severity and myocardial infarction within 6 months prior to screening.\n* History of coronary artery bypass graft (CABG) or major cardiovascular surgical procedures within 6 months prior to screening.\n* History of Buerger's disease or deep vein thrombosis within 3 months prior to screening.\n* Presence of haemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer and intracranial bleeding.\n* Presence or history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular tachycardia with or without adequate treatment, QTc prolongation associated with cardiac disorders, or severe tachyarrhythmia within 6 months prior to screening, which is considered not suitable for this study by Investigator.\n* History of type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.\n* Use of anticoagulant agent(s) within 6 months prior to screening.\n* Use of two or more than two anti-platelet agents within 3 months prior to screening."}, 'identificationModule': {'nctId': 'NCT06886620', 'briefTitle': 'Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genovate Biotechnology Co., Ltd.,'}, 'officialTitle': 'A Phase III Prospective, Randomized, Double Blind, Active Controlled, Multicenter, Parallel Group Study to Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication', 'orgStudyIdInfo': {'id': 'GBL14-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PMR', 'description': 'Cilostazol 200 mg, tablet, PO, QN', 'interventionNames': ['Drug: Cilostazol 200 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pletaal®', 'description': 'Cilostazol 100 mg, tablet, PO, BID', 'interventionNames': ['Drug: Cilostazol 100 mg']}], 'interventions': [{'name': 'Cilostazol 200 mg', 'type': 'DRUG', 'otherNames': ['PMR'], 'description': 'Provided as 1# placebo tablet in the morning and 1# PMR 200 mg/tablet in the evening, orally, for 24 weeks.', 'armGroupLabels': ['PMR']}, {'name': 'Cilostazol 100 mg', 'type': 'DRUG', 'otherNames': ['Pletaal®'], 'description': 'Provided as 1# Pletaal® 100 mg/tablet, orally twice a day, for 24 weeks.', 'armGroupLabels': ['Pletaal®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10449', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Mackay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Cheng Hsin General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital Linkou', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Jen-Kuang Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Chern-En Chiang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}, {'name': 'Jen-Yuan Kuo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mackay Memorail Hospital'}, {'name': 'Ming-Shien Wen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'Yin-Wei Hsian, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cheng-Hsin General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genovate Biotechnology Co., Ltd.,', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}