search
Back to results

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

Primary Purpose

Thrombosis, Venous

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fondaparinux 2.5mg or placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombosis, Venous focused on measuring superficial vein thrombosis, superficial thrombophlebitis, fondaparinux, deep vein thrombosis, venous thromboembolism treatment, thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long diagnosed by compression ultrasound.

Exclusion criteria:

  • Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,
  • deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism within last 6 months, treatment for cancer during last 6 months,
  • anticoagulant medication for more than 48 hours prior to inclusion,
  • need for oral non-steroidal anti-inflammatory drugs during the study, significant bleeding event during past month,
  • major surgery within last 3 months, low platelet count (below 100×109/L),
  • kidney disease (Calculated creatinine clearance < 30 mL/min), woman of child-bearing potential not using reliable contraceptive method

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fondaparinux 2.5mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47
VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.

Secondary Outcome Measures

Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77
VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77
VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within <=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length.
Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77
The number of participants requiring surgery was measured.
Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77
Major bleeding was defined as bleeding that was fatal and/or (1) in a critical area/organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome); (2) associated with a fall in hemoglobin >=20 g/L (1.24 mmol/L); (3) led to a transfusion of >=2 units of packed red blood cells/whole blood. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.
Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77
Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.
Number of Any Adjudicated Bleeding Events at Days 47 and 77
The sum of adjudicated major bleeds, non-major clinically relevant bleeds, and minor bleeds was calculated. Minor bleeding was defined as other clinically overt bleeding events that did not meet the criteria for major or clinically relevant non-major bleeding. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.

Full Information

First Posted
March 2, 2007
Last Updated
January 20, 2017
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00443053
Brief Title
Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)
Official Title
An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment of Patients With Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to Prevent Thromboembolic Complications
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.
Detailed Description
Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebo (CALISTO). An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Venous
Keywords
superficial vein thrombosis, superficial thrombophlebitis, fondaparinux, deep vein thrombosis, venous thromboembolism treatment, thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3002 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fondaparinux 2.5mg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fondaparinux 2.5mg or placebo
Intervention Description
Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day
Primary Outcome Measure Information:
Title
Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47
Description
VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.
Time Frame
Baseline to Day 47
Secondary Outcome Measure Information:
Title
Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77
Description
VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.
Time Frame
Baseline to Day 77
Title
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77
Description
VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within <=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length.
Time Frame
Days 47 and 77
Title
Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77
Description
The number of participants requiring surgery was measured.
Time Frame
Days 47 and 77
Title
Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77
Description
Major bleeding was defined as bleeding that was fatal and/or (1) in a critical area/organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome); (2) associated with a fall in hemoglobin >=20 g/L (1.24 mmol/L); (3) led to a transfusion of >=2 units of packed red blood cells/whole blood. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.
Time Frame
Days 47 (or last dose plus 4 days) and 77
Title
Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77
Description
Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.
Time Frame
Days 47 (or last dose plus 4 days) and 77
Title
Number of Any Adjudicated Bleeding Events at Days 47 and 77
Description
The sum of adjudicated major bleeds, non-major clinically relevant bleeds, and minor bleeds was calculated. Minor bleeding was defined as other clinically overt bleeding events that did not meet the criteria for major or clinically relevant non-major bleeding. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.
Time Frame
Days 47 (or last dose plus 4 days) and 77

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long diagnosed by compression ultrasound. Exclusion criteria: Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction, deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism within last 6 months, treatment for cancer during last 6 months, anticoagulant medication for more than 48 hours prior to inclusion, need for oral non-steroidal anti-inflammatory drugs during the study, significant bleeding event during past month, major surgery within last 3 months, low platelet count (below 100×109/L), kidney disease (Calculated creatinine clearance < 30 mL/min), woman of child-bearing potential not using reliable contraceptive method
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Plzen
ZIP/Postal Code
323 18
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 10
ZIP/Postal Code
101 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 10
ZIP/Postal Code
108 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 2
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
150 05
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 6
ZIP/Postal Code
169 02
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Ricany
ZIP/Postal Code
251 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Tabor
ZIP/Postal Code
390 03
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Saku
ZIP/Postal Code
75501
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
GSK Investigational Site
City
Tartu
ZIP/Postal Code
50410
Country
Estonia
Facility Name
GSK Investigational Site
City
Abbeville
ZIP/Postal Code
80100
Country
France
Facility Name
GSK Investigational Site
City
Ales
ZIP/Postal Code
30100
Country
France
Facility Name
GSK Investigational Site
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
GSK Investigational Site
City
Annecy
ZIP/Postal Code
74000
Country
France
Facility Name
GSK Investigational Site
City
Annonay
ZIP/Postal Code
07100
Country
France
Facility Name
GSK Investigational Site
City
Arras
ZIP/Postal Code
62000
Country
France
Facility Name
GSK Investigational Site
City
Bordeaux
ZIP/Postal Code
33082
Country
France
Facility Name
GSK Investigational Site
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
GSK Investigational Site
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
GSK Investigational Site
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
GSK Investigational Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
GSK Investigational Site
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
GSK Investigational Site
City
Nîmes Cedex 9
ZIP/Postal Code
30029
Country
France
Facility Name
GSK Investigational Site
City
Saint Aubin sur Scie
ZIP/Postal Code
76550
Country
France
Facility Name
GSK Investigational Site
City
Saint-Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
GSK Investigational Site
City
Tarbes
ZIP/Postal Code
65000
Country
France
Facility Name
GSK Investigational Site
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
GSK Investigational Site
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
GSK Investigational Site
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Facility Name
GSK Investigational Site
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
GSK Investigational Site
City
Baesweiler
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
52499
Country
Germany
Facility Name
GSK Investigational Site
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79108
Country
Germany
Facility Name
GSK Investigational Site
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
GSK Investigational Site
City
Karlsbad
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
76307
Country
Germany
Facility Name
GSK Investigational Site
City
Karlsruhe
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
76133
Country
Germany
Facility Name
GSK Investigational Site
City
Lauffen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74348
Country
Germany
Facility Name
GSK Investigational Site
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86150
Country
Germany
Facility Name
GSK Investigational Site
City
Grossheirath
State/Province
Bayern
ZIP/Postal Code
96269
Country
Germany
Facility Name
GSK Investigational Site
City
Hemau
State/Province
Bayern
ZIP/Postal Code
93155
Country
Germany
Facility Name
GSK Investigational Site
City
Muehldorf
State/Province
Bayern
ZIP/Postal Code
84453
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80331
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80333
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
GSK Investigational Site
City
Noerdlingen
State/Province
Bayern
ZIP/Postal Code
86720
Country
Germany
Facility Name
GSK Investigational Site
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90429
Country
Germany
Facility Name
GSK Investigational Site
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97070
Country
Germany
Facility Name
GSK Investigational Site
City
Dahlwitz-Hoppegarten
State/Province
Brandenburg
ZIP/Postal Code
15366
Country
Germany
Facility Name
GSK Investigational Site
City
Potsdam
State/Province
Brandenburg
ZIP/Postal Code
14482
Country
Germany
Facility Name
GSK Investigational Site
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64283
Country
Germany
Facility Name
GSK Investigational Site
City
Eschwege
State/Province
Hessen
ZIP/Postal Code
37269
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60322
Country
Germany
Facility Name
GSK Investigational Site
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65183
Country
Germany
Facility Name
GSK Investigational Site
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18059
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Bevensen
State/Province
Niedersachsen
ZIP/Postal Code
29549
Country
Germany
Facility Name
GSK Investigational Site
City
Leer
State/Province
Niedersachsen
ZIP/Postal Code
26789
Country
Germany
Facility Name
GSK Investigational Site
City
Osnabrueck
State/Province
Niedersachsen
ZIP/Postal Code
49074
Country
Germany
Facility Name
GSK Investigational Site
City
Essen-Kettwig
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45219
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln-Junkersdorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50858
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50760
Country
Germany
Facility Name
GSK Investigational Site
City
Moenchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41065
Country
Germany
Facility Name
GSK Investigational Site
City
Neuss
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41460
Country
Germany
Facility Name
GSK Investigational Site
City
Oberhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46145
Country
Germany
Facility Name
GSK Investigational Site
City
Waldbroel
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51545
Country
Germany
Facility Name
GSK Investigational Site
City
Wuppertal
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42275
Country
Germany
Facility Name
GSK Investigational Site
City
Frankenthal
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67227
Country
Germany
Facility Name
GSK Investigational Site
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67059
Country
Germany
Facility Name
GSK Investigational Site
City
Neustadt
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67434
Country
Germany
Facility Name
GSK Investigational Site
City
Neunkirchen
State/Province
Saarland
ZIP/Postal Code
66538
Country
Germany
Facility Name
GSK Investigational Site
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09130
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01309
Country
Germany
Facility Name
GSK Investigational Site
City
Kirchberg
State/Province
Sachsen
ZIP/Postal Code
08107
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04109
Country
Germany
Facility Name
GSK Investigational Site
City
Altenburg
State/Province
Thueringen
ZIP/Postal Code
04600
Country
Germany
Facility Name
GSK Investigational Site
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07743
Country
Germany
Facility Name
GSK Investigational Site
City
Nordhausen
State/Province
Thueringen
ZIP/Postal Code
99734
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10559
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22177
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22761
Country
Germany
Facility Name
GSK Investigational Site
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
145 61
Country
Greece
Facility Name
GSK Investigational Site
City
Heraklion
ZIP/Postal Code
712 01
Country
Greece
Facility Name
GSK Investigational Site
City
Larisa
ZIP/Postal Code
41110
Country
Greece
Facility Name
GSK Investigational Site
City
Melissia Athens
ZIP/Postal Code
15127
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
GSK Investigational Site
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1039
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1081
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
GSK Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
GSK Investigational Site
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
GSK Investigational Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
GSK Investigational Site
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
GSK Investigational Site
City
Miskolc
ZIP/Postal Code
3501
Country
Hungary
Facility Name
GSK Investigational Site
City
Nyiregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
GSK Investigational Site
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
GSK Investigational Site
City
Szikszó
ZIP/Postal Code
8300
Country
Hungary
Facility Name
GSK Investigational Site
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
GSK Investigational Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
GSK Investigational Site
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
GSK Investigational Site
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
Facility Name
GSK Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
GSK Investigational Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
GSK Investigational Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
GSK Investigational Site
City
Safed
ZIP/Postal Code
13110
Country
Israel
Facility Name
GSK Investigational Site
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
GSK Investigational Site
City
Chieti Scalo
State/Province
Abruzzo
ZIP/Postal Code
66013
Country
Italy
Facility Name
GSK Investigational Site
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
GSK Investigational Site
City
Piacenza
State/Province
Emilia-Romagna
ZIP/Postal Code
29100
Country
Italy
Facility Name
GSK Investigational Site
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
Facility Name
GSK Investigational Site
City
Rimini
State/Province
Emilia-Romagna
ZIP/Postal Code
47900
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20142
Country
Italy
Facility Name
GSK Investigational Site
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
GSK Investigational Site
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90126
Country
Italy
Facility Name
GSK Investigational Site
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
GSK Investigational Site
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
GSK Investigational Site
City
Venezia
State/Province
Veneto
ZIP/Postal Code
30122
Country
Italy
Facility Name
GSK Investigational Site
City
Daugavpils
ZIP/Postal Code
LV5417
Country
Latvia
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1012
Country
Latvia
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV1038
Country
Latvia
Facility Name
GSK Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 KX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1066 EC
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Den Haag
ZIP/Postal Code
2566 MJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Weerselo
ZIP/Postal Code
7651 JH
Country
Netherlands
Facility Name
GSK Investigational Site
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
GSK Investigational Site
City
Gniewkowo
ZIP/Postal Code
88-140
Country
Poland
Facility Name
GSK Investigational Site
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Facility Name
GSK Investigational Site
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Barnaul
ZIP/Postal Code
656038
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620028
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Irkutsk
ZIP/Postal Code
664003
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Lipetsk
ZIP/Postal Code
398055
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
111538
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115 280
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
119 048
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
125299
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Perm
ZIP/Postal Code
614107
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Rostov-na-Donu
ZIP/Postal Code
344019
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
197046
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
198260
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Samara
ZIP/Postal Code
443099
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saratov
ZIP/Postal Code
4100017
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburgh
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Stavropol
ZIP/Postal Code
310
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Tomsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Tumen
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ufa
ZIP/Postal Code
450000
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Yaroslavl
ZIP/Postal Code
150023
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
GSK Investigational Site
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Kosice
ZIP/Postal Code
040 86
Country
Slovakia
Facility Name
GSK Investigational Site
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Avila
ZIP/Postal Code
05071
Country
Spain
Facility Name
GSK Investigational Site
City
Boadilla del Monte (Madrid)
ZIP/Postal Code
28660
Country
Spain
Facility Name
GSK Investigational Site
City
Cartagena (Murcia)
ZIP/Postal Code
30203
Country
Spain
Facility Name
GSK Investigational Site
City
Getafe
ZIP/Postal Code
28905
Country
Spain
Facility Name
GSK Investigational Site
City
Gijon
ZIP/Postal Code
33394
Country
Spain
Facility Name
GSK Investigational Site
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
GSK Investigational Site
City
Marid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Mataro
ZIP/Postal Code
08034
Country
Spain
Facility Name
GSK Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
GSK Investigational Site
City
Sabadell (Barcelona)
ZIP/Postal Code
08208
Country
Spain
Facility Name
GSK Investigational Site
City
San Juan De Alicante
ZIP/Postal Code
3550
Country
Spain
Facility Name
GSK Investigational Site
City
Segovia
ZIP/Postal Code
40002
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
GSK Investigational Site
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
Facility Name
GSK Investigational Site
City
Zamora
ZIP/Postal Code
49021
Country
Spain
Facility Name
GSK Investigational Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
GSK Investigational Site
City
Bruderholz
ZIP/Postal Code
4101
Country
Switzerland
Facility Name
GSK Investigational Site
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
GSK Investigational Site
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
GSK Investigational Site
City
Lausanne
ZIP/Postal Code
1005
Country
Switzerland
Facility Name
GSK Investigational Site
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
GSK Investigational Site
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
GSK Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
GSK Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
GSK Investigational Site
City
Donetsk
ZIP/Postal Code
83045
Country
Ukraine
Facility Name
GSK Investigational Site
City
Ivano-Frankivsk
ZIP/Postal Code
76000
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kharkiv
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kyiv
ZIP/Postal Code
04201
Country
Ukraine
Facility Name
GSK Investigational Site
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
GSK Investigational Site
City
Sevastopol
ZIP/Postal Code
99011
Country
Ukraine
Facility Name
GSK Investigational Site
City
Uzhgorod
ZIP/Postal Code
88010
Country
Ukraine
Facility Name
GSK Investigational Site
City
Vinnitsa
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
GSK Investigational Site
City
Zaporizhzhya
ZIP/Postal Code
69000
Country
Ukraine
Facility Name
GSK Investigational Site
City
Zaporizhzhya
ZIP/Postal Code
69065
Country
Ukraine
Facility Name
GSK Investigational Site
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
23821661
Citation
Leizorovicz A, Becker F, Buchmuller A, Quere I, Prandoni P, Decousus H; CALISTO Study Group. Clinical relevance of symptomatic superficial-vein thrombosis extension: lessons from the CALISTO study. Blood. 2013 Sep 5;122(10):1724-9. doi: 10.1182/blood-2013-04-498014. Epub 2013 Jul 2.
Results Reference
derived
PubMed Identifier
20860504
Citation
Decousus H, Prandoni P, Mismetti P, Bauersachs RM, Boda Z, Brenner B, Laporte S, Matyas L, Middeldorp S, Sokurenko G, Leizorovicz A; CALISTO Study Group. Fondaparinux for the treatment of superficial-vein thrombosis in the legs. N Engl J Med. 2010 Sep 23;363(13):1222-32. doi: 10.1056/NEJMoa0912072.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs