Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-27 @ 1:51 AM
Study NCT ID:
NCT00853450
Status:
COMPLETED
Last Update Posted:
2009-08-19
First Post:
2009-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bleeding Time Study With AZD6482, Clopidogrel and ASA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C578518', 'term': '2-(1-(7-methyl-2-morpholin-4-yl-4-oxo-4H-pyrido(1,2-a)pyrimidin-9-yl)ethylamino)benzoic acid'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-18', 'studyFirstSubmitDate': '2009-02-27', 'studyFirstSubmitQcDate': '2009-02-27', 'lastUpdatePostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Capillary Bleeding Time (CBT)', 'timeFrame': 'Prior to first dose in each treatment period, on study day 6 and 7 in treatment period A and on study day 7 in treatment period B'}], 'secondaryOutcomes': [{'measure': 'Effect on bleeding', 'timeFrame': 'Prior to first dose in each treatment period, twice on study day 6 and three times on study day 7 in treatment period A and twice on study day 7 in treatment period B'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion'}, {'measure': 'Safety variables (adverse events, blood pressure, pulse, ECG, safety lab)', 'timeFrame': 'Repeatedly during the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antiplatelet'], 'conditions': ['Antiplatelet Effect']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on bleeding time when taken together with low-dose ASA.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.\n* Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until the first baseline visit or clinically significant abnormalities in clinical chemistry, haematology, urinalysis or supine BP or pulse\n* Known impaired glucose tolerance, known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or known or suspected Gilbert's syndrome"}, 'identificationModule': {'nctId': 'NCT00853450', 'briefTitle': 'Bleeding Time Study With AZD6482, Clopidogrel and ASA', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Open-label, Single-Centre, Phase I, Crossover Study to Evaluate the Effect of AZD6482, Compared With Clopidogrel, on Bleeding Time in Healthy Volunteers Receiving Low-Dose ASA', 'orgStudyIdInfo': {'id': 'D1700C00004'}, 'secondaryIdInfos': [{'id': 'EudraCT no. 2008-007030-21'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD6482 on top of ASA', 'interventionNames': ['Drug: AZD6482', 'Drug: ASA']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Clopidogrel on top of ASA', 'interventionNames': ['Drug: Clopidogrel', 'Drug: ASA']}], 'interventions': [{'name': 'AZD6482', 'type': 'DRUG', 'description': 'Single intravenous infusion during a maximum of 5 hours', 'armGroupLabels': ['1']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix®'], 'description': 'Oral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7.', 'armGroupLabels': ['2']}, {'name': 'ASA', 'type': 'DRUG', 'otherNames': ['Trombyl®'], 'description': '75 mg orally once daily during 7 days in each treatment arm', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Peter Held', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Mölndal'}, {'name': 'Bo Fransson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AstraZeneca Clinical Pharmacology Unit, Lund'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Peter Held, Medical Science Director, Early Thrombosis & Haemostasis', 'oldOrganization': 'AstraZeneca'}}}}