Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-04-14 @ 10:32 AM
Study NCT ID:
NCT00541320
Status:
WITHDRAWN
Last Update Posted:
2013-04-04
First Post:
2007-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C532873', 'term': '2-(5-chlorothien-2-yl)-N-(1-(1-methyl-2-(morpholin-4-yl)-2-oxoethyl)-2-oxopyrrolidin-3-yl)ethenesulfonamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No longer viable', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'lastUpdateSubmitDate': '2013-04-01', 'studyFirstSubmitDate': '2007-02-12', 'studyFirstSubmitQcDate': '2007-10-09', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of death OR symptomatic or non-symptomatic blood clots in the legs OR symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.', 'timeFrame': 'symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.'}], 'secondaryOutcomes': [{'measure': 'Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery.', 'timeFrame': 'Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery'}]}, 'conditionsModule': {'keywords': ['Anti-thrombolytic direct Factor Xa inhibitor'], 'conditions': ['Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s) and dose regimen of GW813893 for future investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients who are scheduled for primary elective unilateral total knee arthroplasty.\n\nExclusion criteria:\n\n* Women who are not surgically sterile or post-menopausal\n* Have a contra-indication to contract venography\n* Have a known disorder associated with increased risk of bleeding or have been immobile up to 12 weeks before surgery.'}, 'identificationModule': {'nctId': 'NCT00541320', 'briefTitle': 'Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Dose Ranging Trial for the Evaluation of the Safety and Efficacy of GW813893 in the Prophylaxis of Venous Thromboembolism Post Total Knee Replacement Surgery.', 'orgStudyIdInfo': {'id': 'FTI102595'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GW813893', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "GSK Clinical Trials Call Center'", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95991', 'city': 'Yuba City', 'state': 'California', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 39.14045, 'lon': -121.61691}}, {'zip': '33703', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30032', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'GSK Clinical Trials, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}}}}