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Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Samuel Z.Goldhaber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00413374
First received: December 15, 2006
Last updated: April 27, 2012
Last verified: April 2012
Results First Received: June 22, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Intervention: Drug: Enoxaparin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Enoxaparin Recieved low molecular weight heparin (LMWH) as a "bridge" to warfarin

Participant Flow:   Overall Study
    Enoxaparin
STARTED   40 
COMPLETED   34 
NOT COMPLETED   6 
Ineligible due to screening criteria.                3 
Adverse Event                1 
Lost to Follow-up                1 
Surgery                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Enoxaparin Recieved low molecular weight heparin (LMWH) as a "bridge" to warfarin

Baseline Measures
   Enoxaparin 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   35 
>=65 years   5 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.95  (16.2) 
Gender 
[Units: Participants]
 
Female   21 
Male   19 
Region of Enrollment 
[Units: Participants]
 
United States   40 


  Outcome Measures
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1.  Primary:   Major Bleeding Complication   [ Time Frame: 30 Days ]

2.  Primary:   Recurrent VTE   [ Time Frame: 30 Days ]

3.  Primary:   Death   [ Time Frame: 30 Days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Research Coordinator
Organization: Brigham and Women's Hospital
phone: 617-732-6984
e-mail: arao2@partners.org


Publications:

Responsible Party: Samuel Z.Goldhaber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00413374     History of Changes
Other Study ID Numbers: 2006-P-000082
Study First Received: December 15, 2006
Results First Received: June 22, 2011
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board