Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-04-03 @ 8:45 AM
Study NCT ID:
NCT00097357
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2004-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
Sponsor:
Organization:
Raw JSON
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The safety of this treatment will also be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing elective unilateral total knee replacement surgery.\n* Willing and able to undergo bilateral ascending contrast venography.\n* Able to inject (by self or caregiver) study medication subcutaneously.\n\nExclusion Criteria:\n\n* Women of childbearing potential.\n* Women who are pregnant or breastfeeding.\n* Under some conditions, subjects weighing more than 300 lbs. (136kg) and/or Body Mass Index (BMI) \\>=35 kg/m2'}, 'identificationModule': {'nctId': 'NCT00097357', 'briefTitle': 'BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 2 Randomized, Double-Blinded (BMS-562247 and Enoxaparin), Active-Controlled (Enoxaparin and Warfarin), Parallel-Arm, Dose-Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery', 'orgStudyIdInfo': {'id': 'CV185-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A1', 'description': 'Apixaban: 2.5 mg, BID\n\nPLUS\n\nEnoxaparin Placebo', 'interventionNames': ['Drug: Apixaban', 'Drug: Enoxaparin Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A2', 'description': 'Apixaban: 5 mg, BID\n\nPLUS\n\nEnoxaparin Placebo', 'interventionNames': ['Drug: Apixaban', 'Drug: Enoxaparin Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A3', 'description': 'Apixaban: 10 mg, BID\n\nPLUS\n\nEnoxaparin Placebo', 'interventionNames': ['Drug: Apixaban', 'Drug: Enoxaparin Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A4', 'description': 'Apixaban: 5 mg, QD\n\nPLUS\n\nEnoxaparin Placebo', 'interventionNames': ['Drug: Apixaban', 'Drug: Enoxaparin Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A5', 'description': 'Apixaban: 10 mg, QD\n\nPLUS\n\nEnoxaparin Placebo', 'interventionNames': ['Drug: Apixaban', 'Drug: Enoxaparin Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A6', 'description': 'Apixaban: 20 mg, QD\n\nPLUS\n\nEnoxaparin Placebo', 'interventionNames': ['Drug: Apixaban', 'Drug: Enoxaparin Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'E1', 'description': 'Enoxaparin: 30 mg\n\nPLUS\n\nApixaban Placebo', 'interventionNames': ['Drug: Enoxaparin', 'Drug: Apixaban Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'W1', 'description': 'Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'otherNames': ['BMS-562247'], 'description': 'Tablets, Oral, 12 +/- 2 days', 'armGroupLabels': ['A1', 'A2', 'A3', 'A4', 'A5', 'A6']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'description': 'Injection, SQ, Q12H, 12 +/- 2 days', 'armGroupLabels': ['E1']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': 'Tablets, Oral, QD, 12 +/- 2 days', 'armGroupLabels': ['W1']}, {'name': 'Enoxaparin Placebo', 'type': 'DRUG', 'description': 'Injection, SQ, BID, 12 +/- 2 days', 'armGroupLabels': ['A1', 'A2', 'A3', 'A4', 'A5', 'A6']}, {'name': 'Apixaban Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, BID, 12 +/- 2 days', 'armGroupLabels': ['E1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Mobile', 'state': 'Alabama', 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