Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT01178502
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2010-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PGx Study to Develop and Validate the Predictive Warfarin Dosing Algorithm for Personalized Warfarin Pharmacotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples were taken from patients for genotyping about 8ml'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-30', 'studyFirstSubmitDate': '2010-08-09', 'studyFirstSubmitQcDate': '2010-08-09', 'lastUpdatePostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Develop and Validate the Predictive Warfarin Dosing Algorithm', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Valve Diseases']}, 'descriptionModule': {'briefSummary': 'To develop and validate the predictive warfarin dosing algorithm.', 'detailedDescription': 'This study aims to develop and validate the predictive warfarin dosing algorithm for personalized warfarin pharmacotherapy in Korean patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'the patients taking warfarin', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the patients taking warfarin\n\nExclusion Criteria:\n\n* noncompliance'}, 'identificationModule': {'nctId': 'NCT01178502', 'briefTitle': 'PGx Study to Develop and Validate the Predictive Warfarin Dosing Algorithm for Personalized Warfarin Pharmacotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Warfarin Dosing Algorithm for Personalized Warfarin Pharmacotherapy in Korean Patients', 'orgStudyIdInfo': {'id': '09-025'}}, 'contactsLocationsModule': {'locations': [{'zip': '614-735', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Pharmacology and Pharmacogenomics Research Center', 'investigatorFullName': 'Jae-Gook Shin', 'investigatorAffiliation': 'Inje University'}}}}