Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00480636
First received: May 29, 2007
Last updated: July 14, 2010
Last verified: July 2010
Results First Received: May 25, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Acute Deep Vein Thrombosis
Intervention: Drug: Fragmin (dalteparin sodium )

  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
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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
Dalteparin Dalteparin 200 International Units per kilogram (IU/kg) total body weight subcutaneously (SC) once daily (QD) for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.

Participant Flow:   Overall Study
    Dalteparin  
STARTED     102  
COMPLETED     83  
NOT COMPLETED     19  
Death                 12  
Lost to Follow-up                 4  
Unspecified                 2  
Lost to follow-up; subsequently died                 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.
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Reporting Groups
  Description
Dalteparin Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.

Baseline Measures
    Dalteparin  
Number of Participants  
[units: participants]
  102  
Age, Customized  
[units: Participants]
 
Between 18 and 44 years     4  
Between 45 and 64 years     58  
>= 65 years     39  
Unspecified     1  
Age  
[units: years]
Mean ± Standard Deviation
  61.6  ± 10.1  
Gender  
[units: Participants]
 
Female     54  
Male     48  



  Outcome Measures
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1.  Primary:   Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg   [ Time Frame: Month 6 or End of Treatment (EOT) (up to Month 6) ]

2.  Secondary:   Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood   [ Time Frame: Baseline through Month 6 or EOT (up to Month 6) ]

3.  Secondary:   Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)   [ Time Frame: Baseline through Month 6 or EOT (up to Month 6) ]

4.  Secondary:   Percent of Participants With and Without Pulmonary Embolism (PE)   [ Time Frame: Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6) ]

5.  Secondary:   Number of Participants With Recurrent DVT   [ Time Frame: Month 6 or EOT (up to Month 6) ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00480636     History of Changes
Other Study ID Numbers: A6301082
Study First Received: May 29, 2007
Results First Received: May 25, 2010
Last Updated: July 14, 2010
Health Authority: Slovakia: State Institute for Drug Control