Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-01-28 @ 4:39 AM
Study NCT ID:
NCT03666650
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2018-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552171', 'term': 'edoxaban'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-13', 'studyFirstSubmitDate': '2018-09-08', 'studyFirstSubmitQcDate': '2018-09-08', 'lastUpdatePostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation of edoxaban peak plasma concentrations and viscoelastic analysis', 'timeFrame': '1 day', 'description': 'viscoelastic test values and blood coagulation laboratory parameters'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Coagulation Disorder']}, 'descriptionModule': {'briefSummary': 'Relationship of edoxaban plasma concentration and blood coagulation in healthy volunteers using standard laboratory tests and viscoelastic analysis'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nhealthy\n\nExclusion Criteria:\n\nintolerance of the study drug history of bleeding disorder or similar'}, 'identificationModule': {'nctId': 'NCT03666650', 'acronym': 'EdoRot', 'briefTitle': 'NOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Relationship of Edoxaban Plamsa Concentration and Blood Coagulation in Healthy Volunteers Using Standard Laboratory Tests and Viscoelastic Analysis', 'orgStudyIdInfo': {'id': 'T224/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Rotem', 'interventionNames': ['Drug: Edoxaban 60 MG']}], 'interventions': [{'name': 'Edoxaban 60 MG', 'type': 'DRUG', 'description': 'Viscoelastic analysis and standard laboratory tests after edoxaban ingestion', 'armGroupLabels': ['Rotem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20500', 'city': 'Turku', 'state': 'Southwest Finland', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Study Principal Investigator, Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital', 'investigatorFullName': 'Marko Peltoniemi', 'investigatorAffiliation': 'Turku University Hospital'}}}}