Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-31 @ 1:56 AM
Study NCT ID:
NCT03231293
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2017-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fimasartan Blood Pressure Lowering After Acute Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002545', 'term': 'Brain Ischemia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1035}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-01', 'studyFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2017-07-25', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BP', 'timeFrame': '24 weeks', 'description': 'Blood pressure control rate(\\<140/90 mmHg)'}], 'secondaryOutcomes': [{'measure': 'BP', 'timeFrame': '4, 12 weeks', 'description': 'Blood pressure control rate(\\<140/90 mmHg)'}, {'measure': 'BP', 'timeFrame': '4, 12, 24 weeks', 'description': 'Blood pressure changes'}, {'measure': 'mRS', 'timeFrame': '4, 12, 24 weeks', 'description': 'mRS changes'}, {'measure': 'Fimasartan-based treatment', 'timeFrame': '24 weeks', 'description': 'Fimasartan-based treatment modalities'}, {'measure': 'Fimasartan starting point', 'timeFrame': '24 weeks', 'description': 'Fimasartan starting point after stroke'}, {'measure': 'Stroke recurrence', 'timeFrame': '24 weeks', 'description': 'Rate of stroke recurrence'}, {'measure': 'Cardiovascular events', 'timeFrame': '24 weeks', 'description': 'Incidence of cardiovascular events'}, {'measure': 'Mortality rates from cardiovascular disease', 'timeFrame': '24 weeks', 'description': 'Mortality rates from cardiovascular disease'}, {'measure': 'Mortality rates of any cause', 'timeFrame': '24 weeks', 'description': 'Mortality rates of any cause'}, {'measure': 'Adverse events', 'timeFrame': '24 weeks', 'description': 'Adverse events related to antihypertensive treatments'}]}, 'conditionsModule': {'conditions': ['Hypertension', 'Ischemic Stroke', 'Transient Ischemic Attack']}, 'referencesModule': {'references': [{'pmid': '34184441', 'type': 'DERIVED', 'citation': 'Hong KS, Kwon SU, Park JH, Cha JK, Jung JM, Kim YJ, Lee KB, Sohn SI, Lee YS, Rha JH, Kwon JH, Han SW, Kim BJ, Koo J, Choi JC, Sung SM, Lee SJ, Park MS, Ahn SH, Bang OY, Hwang YH, Nam HS, Park JM, Bae HJ, Kim EG, Lee KY, Oh MS. Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia: The Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia Study. J Clin Neurol. 2021 Jul;17(3):344-353. doi: 10.3988/jcn.2021.17.3.344.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of fimasartan-based antihypertensive treatment and prognosis in post-acute phase of ischemic stroke or transient ischemic attack patients. All participants will receive fimasartan, and the investigators will follow them up for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1,032 subjects of post-acute phase of ischemic stroke or transient ischemic attack patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic stroke or transient ischemic attack occurs after 7 days to 3 months.\n* Mean blood pressure measured 3 times at the first visit (Visit 1) should be over 140 mmHg for systolic blood pressure or 90 mmHg for diastolic blood pressure\n* Suitable for administration of fimasartan\n* The life expectancy should be over 6 months.\n\nExclusion Criteria:\n\n* Patients already treated with antihypertensive medications\n* Hemorrhagic stroke patients'}, 'identificationModule': {'nctId': 'NCT03231293', 'acronym': 'FABULOUS', 'briefTitle': 'Fimasartan Blood Pressure Lowering After Acute Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Multicenter Longitudinal Observational Study to Assess the Effectiveness of Fimasartan-based Antihypertensive Treatment and Prognosis in Post-Acute Phase of Ischemic Stroke or Transient Ischemic Attack', 'orgStudyIdInfo': {'id': 'BR-FMS-OS-401'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ansan', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 36.8741, 'lon': 126.2116}}, {'city': 'Anyang', 'country': 'South Korea', 'facility': 'Hallym University Medical Center', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Daejeon Eulji Medical Center', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Goyang', 'country': 'South Korea', 'facility': 'Inje University Ilsan Paik Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'city': 'Goyang', 'country': 'South Korea', 'facility': 'Myongji Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chosun University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jeju City', 'country': 'South Korea', 'facility': 'Jeju National University Hospital', 'geoPoint': {'lat': 33.50972, 'lon': 126.52194}}, {'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Inje University Sanggye Paik Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyunghee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Nowon Eulji Medical Center, Eulji University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Myung Sook Hong', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boryung Pharmaceutical Co., Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}