Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT00200356
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002544', 'term': 'Cerebral Infarction'}], 'ancestors': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077553', 'term': 'Edaravone'}, {'id': 'C034364', 'term': 'ozagrel'}], 'ancestors': [{'id': 'D000983', 'term': 'Antipyrine'}, {'id': 'D047069', 'term': 'Pyrazolones'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.', 'otherNumAtRisk': 194, 'otherNumAffected': 102, 'seriousNumAtRisk': 194, 'seriousNumAffected': 27}, {'id': 'EG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.', 'otherNumAtRisk': 198, 'otherNumAffected': 107, 'seriousNumAtRisk': 198, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 64}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 33}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Anastomotic ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Anti-neutrophil cytoplasmic antibody positive vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Brain herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Haemorrhagic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hemiplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Psychotic disorder due to a general medical condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Thrombotic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Barthel Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.'}, {'id': 'OG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'The Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.\n\nThe number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline NIH Stroke Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.'}, {'id': 'OG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before treatment initiation', 'description': 'The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'NIH Stroke Scale Score at 14 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.'}, {'id': 'OG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days', 'description': 'The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'NIH Stroke Scale Score at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.'}, {'id': 'OG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 1 month after treatment initiation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'the Rate of Patients With a Modified Rankin Scale Score of 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.'}, {'id': 'OG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.'}], 'classes': [{'title': 'Score(0-1)', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': '0', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'NIH Stroke Scale Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.'}, {'id': 'OG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 3 months after treatment initiation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Japan Stroke Scale (Motor Function) Score at 14 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.'}, {'id': 'OG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.521', 'spread': '6.651', 'groupId': 'OG000'}, {'value': '4.686', 'spread': '6.872', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Japan Stroke Scale (Motor Function) Score at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.'}, {'id': 'OG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.632', 'spread': '6.086', 'groupId': 'OG000'}, {'value': '3.680', 'spread': '5.885', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Japan Stroke Scale (Motor Function) Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.'}, {'id': 'OG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.507', 'spread': '5.232', 'groupId': 'OG000'}, {'value': '2.927', 'spread': '5.361', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Rankin Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.'}, {'id': 'OG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.'}, {'id': 'FG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '202'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '195'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Nontreatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Edaravone', 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.'}, {'id': 'BG001', 'title': 'Ozagrel', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'birth-19 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '20-64 years', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}, {'title': '65- years', 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-09', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2012-09-13', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-09', 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Rate of Patients With a Modified Rankin Scale Score of 0-1', 'timeFrame': '3 months', 'description': 'The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.'}], 'secondaryOutcomes': [{'measure': 'Barthel Index Score', 'timeFrame': '3 months', 'description': 'The Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.\n\nThe number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation.'}, {'measure': 'Baseline NIH Stroke Scale Score', 'timeFrame': 'Before treatment initiation', 'description': 'The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead).'}, {'measure': 'NIH Stroke Scale Score at 14 Days', 'timeFrame': '14 days', 'description': 'The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation.'}, {'measure': 'NIH Stroke Scale Score at 1 Month', 'timeFrame': '1 month', 'description': 'The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 1 month after treatment initiation.'}, {'measure': 'NIH Stroke Scale Score at 3 Months', 'timeFrame': '3 months', 'description': 'The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 3 months after treatment initiation.'}, {'measure': 'Japan Stroke Scale (Motor Function) Score at 14 Days', 'timeFrame': '14 days', 'description': 'The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation.'}, {'measure': 'Japan Stroke Scale (Motor Function) Score at 1 Month', 'timeFrame': '1 month', 'description': 'The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation.'}, {'measure': 'Japan Stroke Scale (Motor Function) Score at 3 Months', 'timeFrame': '3 months', 'description': 'The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation.'}, {'measure': 'Modified Rankin Scale Score', 'timeFrame': '6 months', 'description': 'The number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cerebral Infarction']}, 'referencesModule': {'references': [{'pmid': '19321945', 'type': 'RESULT', 'citation': 'Shinohara Y, Saito I, Kobayashi S, Uchiyama S. Edaravone (radical scavenger) versus sodium ozagrel (antiplatelet agent) in acute noncardioembolic ischemic stroke (EDO trial). Cerebrovasc Dis. 2009;27(5):485-92. doi: 10.1159/000210190. Epub 2009 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients can be receive drug treatment within 24 hours after stroke onset\n2. Patients with a level of consciousness between 0 (alert) and 3 (unable to recall name and date of birth) according to the Japan Coma Scale\n3. Patients with motor dysfunction of upper and/or lower extremities\n4. Patients aged 20 years or older when giving informed consent\n\nExclusion Criteria:\n\n1. Serum creatinine of \\>1.5 mg/dL\n2. Embolic infarction\n3. Intracranial haemorrhage\n4. Large infarction with severe consciousness\n5. Transient ischemic attack (TIA)\n6. A modified Rankin Scale score of ≥2 before stroke onset\n7. Patients were receive drug treatment (argatroban, urokinase, tissue plasminogen activator, heparin, warfarin sodium, aspirin, ticlopidine hydrochloride, cilostazol, edaravone and sodium ozagrel) after stroke onset\n8. Patients were receive surgical treatment or intravascular treatment\n9. With severe complications (cirrhosis, heart failure, etc.)\n10. Treating malignant tumor\n11. Pregnant or possibly pregnant women, nursing mothers\n12. History of edaravone, sodium ozagrel and ozagrel hydrochloride sensitivity\n13. Less than 3 months since any other clinical trial or postmarketing study'}, 'identificationModule': {'nctId': 'NCT00200356', 'briefTitle': 'Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'Edaravone-Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) Comparative Post-Marketing Study on Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'MCI186-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Edaravone', 'interventionNames': ['Drug: Edaravone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ozagrel', 'interventionNames': ['Drug: Sodium Ozagrel']}], 'interventions': [{'name': 'Edaravone', 'type': 'DRUG', 'otherNames': ['Radicut'], 'description': 'Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.', 'armGroupLabels': ['Edaravone']}, {'name': 'Sodium Ozagrel', 'type': 'DRUG', 'description': 'Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.', 'armGroupLabels': ['Ozagrel']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yukito Shinohara, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}