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Enoxaparin in Acute Venous Thromboembolic Disease

Primary Purpose

Venous Thrombosis

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
enoxaparin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

enoxaparin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2005
Last Updated
February 2, 2010
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00265993
Brief Title
Enoxaparin in Acute Venous Thromboembolic Disease
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 Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
Study objectives : To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
enoxaparin
Intervention Type
Drug
Intervention Name(s)
enoxaparin
Intervention Description
All patients will be treated with enoxaparin 1.5 mg/kg, once a day, subcutaneously for up to 10 days. 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.
Primary Outcome Measure Information:
Title
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edibe Taylan
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Enoxaparin in Acute Venous Thromboembolic Disease

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