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Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00443053
First Posted: March 5, 2007
Last Update Posted: March 6, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: July 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Thrombosis, Venous
Intervention: Drug: Fondaparinux 2.5mg or placebo

  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
No text entered.

Reporting Groups
  Description
Fondaparinux 2.5 mg Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
Placebo Matching placebo

Participant Flow:   Overall Study
    Fondaparinux 2.5 mg   Placebo
STARTED   1502   1500 
COMPLETED   1481   1467 
NOT COMPLETED   21   33 
Adverse Event                2                1 
Withdrawal by Subject                9                18 
Lost to Follow-up                4                5 
Did Not Meet Eligibility Criteria                1                0 
Noncompliance                2                1 
Other                3                4 
Physician Decision                0                4 



  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
Fondaparinux 2.5 mg Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
Placebo Matching placebo
Total Total of all reporting groups

Baseline Measures
   Fondaparinux 2.5 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1502   1500   3002 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.1  (13.29)   56.9  (13.56)   57.0  (13.43) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      974  64.8%      944  62.9%      1918  63.9% 
Male      528  35.2%      556  37.1%      1084  36.1% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White, European Heritage   1485   1492   2977 
Arabic/North African Heritage   15   4   19 
African American Heritage   0   2   2 
Asian/South Asian Heritage   0   1   1 
Mixed Race   1   0   1 
Missing   1   1   2 


  Outcome Measures
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1.  Primary:   Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47   [ Time Frame: Baseline to Day 47 ]

2.  Secondary:   Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77   [ Time Frame: Baseline to Day 77 ]

3.  Secondary:   Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77   [ Time Frame: Days 47 and 77 ]

4.  Secondary:   Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77   [ Time Frame: Days 47 and 77 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77
Measure Description The number of participants requiring surgery was measured.
Time Frame Days 47 and 77  

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.
ITT Population

Reporting Groups
  Description
Fondaparinux 2.5 mg Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
Placebo Matching placebo

Measured Values
   Fondaparinux 2.5 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 1502   1500 
Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77 
[Units: Participants]
   
Day 47   11   57 
Day 77   15   61 

No statistical analysis provided for Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77



5.  Secondary:   Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77   [ Time Frame: Days 47 (or last dose plus 4 days) and 77 ]

6.  Secondary:   Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77   [ Time Frame: Days 47 (or last dose plus 4 days) and 77 ]

7.  Secondary:   Number of Any Adjudicated Bleeding Events at Days 47 and 77   [ Time Frame: Days 47 (or last dose plus 4 days) and 77 ]


  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