Enoxaparin in Acute Venous Thromboembolic Disease
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Venous Thrombosis
Intervention: enoxaparin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Edibe Taylan, Study Director, Affiliation: Sanofi
Summary
Study objectives :
- To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute
venous thromboembolic disease.
Clinical Details
Official title: The Efficacy of Subcutaneous Enoxaparin Once Daily in the Treatment of Acute Venous Thromboembolic Disease: an Open-labelled, Non-comparative, Multicentric, Phase IV Trial
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Sanofi-Aventis Administrative Office, Istanbul, Turkey
Additional Information
Starting date: December 2004
Last updated: February 2, 2010
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