Enoxaparin in Acute Venous Thromboembolic Disease

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Study objectives :

• To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Enoxaparin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.