Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02262533
Status:
COMPLETED
Last Update Posted:
2015-08-10
First Post:
2014-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}, {'id': 'D001262', 'term': 'Atenolol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-06', 'studyFirstSubmitDate': '2014-10-09', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apixaban and Atenolol plasma concentration', 'timeFrame': 'Days 1-13', 'description': 'Blood samples for Atenolol PK were collected on days 1-3 of each period (Treatment B and C). Blood samples for Apixaban PK were collected on days 1-4 of each period (Treatment A and C)'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability based on adverse events (AE) reports and the results of vital sign measurements, electrocardiogram (ECGs), physical examinations, and clinical laboratory tests', 'timeFrame': 'Days 1-13'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['N/A - Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness, history of hypotension, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years'}, 'identificationModule': {'nctId': 'NCT02262533', 'briefTitle': 'Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CV185-033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A: Apixaban', 'description': 'Apixaban tablet by mouth on specified day', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: Atenolol', 'description': 'Atenolol tablet by mouth on specified day', 'interventionNames': ['Drug: Atenolol']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C: Apixaban and Atenolol', 'description': 'Apixaban and Atenolol tablets by mouth on specified day', 'interventionNames': ['Drug: Apixaban', 'Drug: Atenolol']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'armGroupLabels': ['Treatment A: Apixaban', 'Treatment C: Apixaban and Atenolol']}, {'name': 'Atenolol', 'type': 'DRUG', 'armGroupLabels': ['Treatment B: Atenolol', 'Treatment C: Apixaban and Atenolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08690', 'city': 'Hamilton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Bms Clinical Research Center', 'geoPoint': {'lat': 40.20706, 'lon': -74.08125}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}