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Enoxaparin in Acute Venous Thromboembolic Disease

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.
 
ClinicalTrials.gov Identifier: NCT00265993
Recruitment Status : Completed
First Posted : December 15, 2005
Last Update Posted : February 3, 2010
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE December 14, 2005
First Posted Date  ICMJE December 15, 2005
Last Update Posted Date February 3, 2010
Study Start Date  ICMJE December 2004
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enoxaparin in Acute Venous Thromboembolic Disease
Official Title  ICMJE The Efficacy of Subcutaneous Enoxaparin Once Daily in the Treatment of Acute Venous Thromboembolic Disease: an Open-labelled, Non-comparative, Multicentric, Phase IV Trial
Brief Summary

Study objectives :

  • To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Venous Thrombosis
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 1
enoxaparin
Intervention: Drug: enoxaparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2009)
251
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00265993
Other Study ID Numbers  ICMJE XRP4563A_4001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Edibe Taylan Sanofi
PRS Account Sanofi
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP