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CompletedNCT00265993Updated Feb 3, 2010

Enoxaparin in Acute Venous Thromboembolic Disease

A Phase 4 interventional study of enoxaparin in Venous Thrombosis, sponsored by Sanofi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-02-03.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
251
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Study objectives :

  • To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.
02

Conditions studied

  • Venous Thrombosis

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03

In context

Venous Thrombosis

787 studies on the registry are indexed under Venous Thrombosis; 123 are open to participants now.

This study's enrollment of 251 is above the median of 131 across 463 interventional studies indexed under Venous Thrombosis.

Browse Venous Thrombosis studies →

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
251 participants (actual)

Study arms

  • Experimental
    1

    enoxaparin

    Drug: enoxaparin

Interventions

  • Drugenoxaparin

    * 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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Istanbul, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2004, a primary completion of Jan 2009 and a completion of Jan 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2005
First posted
Dec 15, 2005
Start
Dec 2004
Primary completionActual
Jan 2009
CompletionActual
Jan 2009
Last update
Feb 3, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 3, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00265993
Lead sponsor
Sanofi
First posted
Dec 15, 2005
Start date
Dec 2004
Primary completion
Jan 2009
Completion
Jan 2009
Last update
Feb 3, 2010

Study contacts

Edibe Taylan
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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