Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-26 @ 8:32 PM
Study NCT ID:
NCT01148368
Status:
COMPLETED
Last Update Posted:
2012-01-09
First Post:
2010-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558933', 'term': 'fimasartan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-06', 'studyFirstSubmitDate': '2010-06-21', 'studyFirstSubmitQcDate': '2010-06-21', 'lastUpdatePostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pharmacokinetic characteristic of fimasartan', 'timeFrame': '0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h', 'description': 'AUC, Cmax, Tmax, T1/2, and CL/F of fimasartan'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fimasartan', 'renal impairment', 'hypertension'], 'conditions': ['Renal Impairment']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal impairment patients and healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\<Renal impairment patient\\>\n\n* age: 20-65 years\n* eGFR: \\< 30ml/min/1.73m\\^2\n* not on dialysis\n* body weight: greater than 55kg\n* written informed consent\n\n\\<Healthy volunteer\\>\n\n* age: 20-65 years\n* body weight: greater than 55kg\n* written informed consent\n\nExclusion Criteria:\n\n* AST, ALT \\> 1.5 times of upper normal range\n* positive drug or alcohol screening'}, 'identificationModule': {'nctId': 'NCT01148368', 'briefTitle': 'A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers', 'orgStudyIdInfo': {'id': 'A657-BR-CT-113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'renal impairment patients', 'description': 'renal impairment patients who eGFR is lower than 30 ml/min/1.73m\\^2 without hemodialysis', 'interventionNames': ['Drug: fimasartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'healthy volunteers', 'description': 'healthy volunteers group', 'interventionNames': ['Drug: fimasartan']}], 'interventions': [{'name': 'fimasartan', 'type': 'DRUG', 'description': 'single administration of fimasartan 120mg', 'armGroupLabels': ['healthy volunteers', 'renal impairment patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yon Su Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}