Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT00265993
Status:
COMPLETED
Last Update Posted:
2010-02-03
First Post:
2005-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enoxaparin in Acute Venous Thromboembolic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-02', 'studyFirstSubmitDate': '2005-12-14', 'studyFirstSubmitQcDate': '2005-12-14', 'lastUpdatePostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of bleeding emerged during the study drug administration; Frequency of bleeding emerged during 3 months of monitorization when the patient is on oral anticoagulants.', 'timeFrame': '3 months'}]}, 'conditionsModule': {'conditions': ['Venous Thrombosis']}, 'descriptionModule': {'briefSummary': 'Study objectives :\n\n* To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with symptomatic lower-extremity deep venous thrombosis confirmed by doppler USG (ultrasonography), with or without confirmed symptomatic pulmonary embolism associated with provoked risk factors\n\nExclusion Criteria:\n\n* Patients with a history of heparin or warfarin treatment longer than 24 hours,\n* Patients requiring thrombolytic treatment,\n* Patients having thrombophilia diagnosis,\n* Patients with prior deep vein thrombosis or pulmonary emboli evidence,\n* Patients with familial bleeding disorder,\n* Patients who are at any known bleeding risk, such as active bleeding, active ulcerative bowel disease, angiodysplasia and having oculary, spinal or central nervous system surgery within the last month\n* Patients with renal failure (serum creatinine concentration \\> 180 mmol/L or \\> 2.03 mg/dL),\n* Patients with severe hepatic failure\n* Patients with history of allergy against heparin and protamine,\n* Patients with history of thrombocytopenia associated with heparin administration or of skin necrosis after heparin or warfarin treatment,\n* Patients participating in another clinical study within the last 4 months\n* Patients who are pregnant\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00265993', 'briefTitle': 'Enoxaparin in Acute Venous Thromboembolic Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'The Efficacy of Subcutaneous Enoxaparin Once Daily in the Treatment of Acute Venous Thromboembolic Disease: an Open-labelled, Non-comparative, Multicentric, Phase IV Trial', 'orgStudyIdInfo': {'id': 'XRP4563A_4001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'enoxaparin', 'interventionNames': ['Drug: enoxaparin']}], 'interventions': [{'name': 'enoxaparin', 'type': 'DRUG', 'description': '* All patients will be treated with enoxaparin 1.5 mg/kg, once a day, subcutaneously for up to 10 days.\n* Long-term oral anticoagulation will be started in all patients after 24 hours of initiation of enoxaparin treatment and continued at least for 3 months.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Edibe Taylan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}