Status:
COMPLETED
Enoxaparin in Acute Venous Thromboembolic Disease
Lead Sponsor:
Sanofi
Conditions:
Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Study objectives : * To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients with a history of heparin or warfarin treatment longer than 24 hours,
- Patients requiring thrombolytic treatment,
- Patients having thrombophilia diagnosis,
- Patients with prior deep vein thrombosis or pulmonary emboli evidence,
- Patients with familial bleeding disorder,
- 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
- Patients with renal failure (serum creatinine concentration \> 180 mmol/L or \> 2.03 mg/dL),
- Patients with severe hepatic failure
- Patients with history of allergy against heparin and protamine,
- Patients with history of thrombocytopenia associated with heparin administration or of skin necrosis after heparin or warfarin treatment,
- Patients participating in another clinical study within the last 4 months
- Patients who are pregnant
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT00265993
Start Date
December 1 2004
End Date
January 1 2009
Last Update
February 3 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Istanbul, Turkey (Türkiye)