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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:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00443053
First received: March 2, 2007
Last updated: January 20, 2017
Last verified: January 2017
Results First Received: 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
  Show All Outcome Measures

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 ]

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
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Time Frame No text entered.
Additional Description Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.

Frequency Threshold
Threshold above which other adverse events are reported   1%  

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

Other Adverse Events
    Fondaparinux 2.5 mg   Placebo
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   95/1499 (6.34%)   79/1488 (5.31%) 
General disorders     
Asthenia † 1     
# participants affected / at risk   14/1499 (0.93%)   16/1488 (1.08%) 
Nervous system disorders     
Headache † 1     
# participants affected / at risk   34/1499 (2.27%)   31/1488 (2.08%) 
Skin and subcutaneous tissue disorders     
Injection site hematoma † 1     
# participants affected / at risk   27/1499 (1.80%)   17/1488 (1.14%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   20/1499 (1.33%)   15/1488 (1.01%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)



  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