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Enoxaparin in Acute Venous Thromboembolic Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00265993
First Posted: December 15, 2005
Last Update Posted: February 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose

Study objectives :

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

Condition Intervention Phase
Venous Thrombosis Drug: enoxaparin Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Sanofi:

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. [ Time Frame: 3 months ]

Enrollment: 251
Study Start Date: December 2004
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
enoxaparin
Drug: enoxaparin
  • 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265993


Locations
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Edibe Taylan Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00265993     History of Changes
Other Study ID Numbers: XRP4563A_4001
First Submitted: December 14, 2005
First Posted: December 15, 2005
Last Update Posted: February 3, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases