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Enoxaparin in Acute Venous Thromboembolic Disease

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00265993
First received: December 14, 2005
Last updated: February 2, 2010
Last verified: February 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265993

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00265993     History of Changes
Other Study ID Numbers: XRP4563A_4001
Study First Received: December 14, 2005
Last Updated: February 2, 2010
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
 Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 13, 2013