Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-04-19 @ 6:14 AM
Study NCT ID:
NCT02394392
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2015-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Characteristics and Medication Satisfaction of Kanarb Tablet in Korean Hypertensive Patient(Kanarb-Hypertension Epidemiology Medication Satisfaction Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12691}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-07', 'studyFirstSubmitDate': '2015-03-10', 'studyFirstSubmitQcDate': '2015-03-19', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of life questionnaire for hypertension', 'timeFrame': 'up to 1 month'}, {'measure': 'medication satisfaction questionnaire', 'timeFrame': 'up to 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Drug compliance questionnaire', 'timeFrame': 'up to 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medication satisfaction', 'Quality of life', 'Drug compliance'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '30186623', 'type': 'DERIVED', 'citation': 'Oh DJ, Han SE, Jeong SH, Hong MS, Choe SC. Clinical characteristics and satisfaction with the fimasartan in Korean hypertensive patients: a prospective, cross-sectional and open-label, 8-week switching study (Kanarb-hypertension epidemiology medication satisfaction study; K-HEMS study). Clin Hypertens. 2018 Sep 1;24:10. doi: 10.1186/s40885-018-0096-2. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': '1. Investigate the clinical characteristics, medication satisfaction and quality of life of anti-hypertensive drugs in Korean hypertensive patients\n2. Observe the changes of medication satisfaction and compliance in patients after switchting to Fimasartan'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '14,000 hypertensive patients anticipated 30% of hypertensive patients who does not satisfied their anti-hypertensive drugs', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nStep1\n\n* Over 20 years old\n* Essential hypertensive patients who taking anti-hypertensive drugs during previous 1 month\n\nStep2\n\n* Patients does not taking Fimasartan\n* Patient's medication satisfaction score under 4\n\nExclusion Criteria:\n\n* Patients with secondary hypertension\n* Patients with orthostatic hypotension who has sign and symptom\n* Patients with known severe or malignancy retinopathy\n* Patients with significant investigations; abnormal renal function\n* Childbearing and breast-feeding women\n* Patients with history of allergic reaction to any angiotensin II antagonist"}, 'identificationModule': {'nctId': 'NCT02394392', 'acronym': 'K-HEMS', 'briefTitle': 'Clinical Characteristics and Medication Satisfaction of Kanarb Tablet in Korean Hypertensive Patient(Kanarb-Hypertension Epidemiology Medication Satisfaction Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'Clinical Characteristics and Medication Satisfaction of Kanarb Tablet in Korean Hypertensive Patient: a Prospective, Cross-sectional and Open-label 8 Week Switching Study', 'orgStudyIdInfo': {'id': 'BR-FMS-OB-401'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea university Guro hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}