Clinical trial NCT00443053: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thrombosis, Venous
Keywords: superficial vein thrombosis
superficial thrombophlebitis
fondaparinux
deep vein thrombosis
venous thromboembolism treatment
thrombosis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-05
Enrollment: 3002
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47
timeFrame: Baseline to Day 47
Secondary outcomes:
measure: Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77
timeFrame: Baseline to Day 77
measure: Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77
timeFrame: Days 47 and 77
measure: Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77
timeFrame: Days 47 and 77
measure: Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77
timeFrame: Days 47 (or last dose plus 4 days) and 77
measure: Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77
timeFrame: Days 47 (or last dose plus 4 days) and 77
measure: Number of Any Adjudicated Bleeding Events at Days 47 and 77
timeFrame: Days 47 (or last dose plus 4 days) and 77
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Brno
country: Czech Republic
facility: GSK Investigational Site
city: Olomouc
country: Czech Republic
facility: GSK Investigational Site
city: Plzen
country: Czech Republic
facility: GSK Investigational Site
city: Praha 10
country: Czech Republic
facility: GSK Investigational Site
city: Praha 10
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facility: GSK Investigational Site
city: Praha 2
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facility: GSK Investigational Site
city: Praha 4
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facility: GSK Investigational Site
city: Praha 5
country: Czech Republic
facility: GSK Investigational Site
city: Praha 6
country: Czech Republic
facility: GSK Investigational Site
city: Ricany
country: Czech Republic
facility: GSK Investigational Site
city: Tabor
country: Czech Republic
facility: GSK Investigational Site
city: Saku
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Abbeville
country: France
facility: GSK Investigational Site
city: Ales
country: France
facility: GSK Investigational Site
city: Amiens
country: France
facility: GSK Investigational Site
city: Annecy
country: France
facility: GSK Investigational Site
city: Annonay
country: France
facility: GSK Investigational Site
city: Arras
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facility: GSK Investigational Site
city: Bordeaux
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facility: GSK Investigational Site
city: Brest
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facility: GSK Investigational Site
city: Clermont Ferrand
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facility: GSK Investigational Site
city: Grenoble
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facility: GSK Investigational Site
city: Montpellier
country: France
facility: GSK Investigational Site
city: Nice
country: France
facility: GSK Investigational Site
city: Nîmes Cedex 9
country: France
facility: GSK Investigational Site
city: Saint Aubin sur Scie
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facility: GSK Investigational Site
city: Saint-Priest en Jarez
country: France
facility: GSK Investigational Site
city: Tarbes
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facility: GSK Investigational Site
city: Toulon
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facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Valenciennes
country: France
facility: GSK Investigational Site
city: Villeurbanne
country: France
facility: GSK Investigational Site
city: Baesweiler
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Heidelberg
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facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Karlsbad
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facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Karlsruhe
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facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Lauffen
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facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Augsburg
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facility: GSK Investigational Site
state: Bayern
city: Grossheirath
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facility: GSK Investigational Site
state: Bayern
city: Hemau
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facility: GSK Investigational Site
state: Bayern
city: Muehldorf
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facility: GSK Investigational Site
state: Bayern
city: Muenchen
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facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
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facility: GSK Investigational Site
state: Bayern
city: Noerdlingen
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facility: GSK Investigational Site
state: Bayern
city: Nuernberg
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facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
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facility: GSK Investigational Site
state: Bayern
city: Dahlwitz-Hoppegarten
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facility: GSK Investigational Site
state: Brandenburg
city: Potsdam
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Darmstadt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Eschwege
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
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facility: GSK Investigational Site
state: Hessen
city: Wiesbaden
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facility: GSK Investigational Site
state: Hessen
city: Rostock
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facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
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facility: GSK Investigational Site
state: Niedersachsen
city: Leer
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facility: GSK Investigational Site
state: Niedersachsen
city: Osnabrueck
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facility: GSK Investigational Site
state: Niedersachsen
city: Essen-Kettwig
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln-Junkersdorf
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Moenchengladbach
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Oberhausen
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Waldbroel
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Wuppertal
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
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facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Ludwigshafen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Neustadt
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Neunkirchen
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facility: GSK Investigational Site
state: Saarland
city: Chemnitz
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facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Kirchberg
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facility: GSK Investigational Site
state: Sachsen
city: Leipzig
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facility: GSK Investigational Site
state: Sachsen
city: Altenburg
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facility: GSK Investigational Site
state: Thueringen
city: Jena
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facility: GSK Investigational Site
state: Thueringen
city: Nordhausen
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facility: GSK Investigational Site
state: Thueringen
city: Berlin
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facility: GSK Investigational Site
city: Berlin
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facility: GSK Investigational Site
city: Berlin
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facility: GSK Investigational Site
city: Hamburg
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city: Hamburg
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facility: GSK Investigational Site
city: Hamburg
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facility: GSK Investigational Site
city: Hamburg
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facility: GSK Investigational Site
city: Alexandroupolis
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Heraklion
country: Greece
facility: GSK Investigational Site
city: Larisa
country: Greece
facility: GSK Investigational Site
city: Melissia Athens
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Bekescsaba
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Debrecen
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facility: GSK Investigational Site
city: Esztergom
country: Hungary
facility: GSK Investigational Site
city: Gyula
country: Hungary
facility: GSK Investigational Site
city: Kaposvár
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
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city: Nyiregyháza
country: Hungary
facility: GSK Investigational Site
city: Pécs
country: Hungary
facility: GSK Investigational Site
city: Szikszó
country: Hungary
facility: GSK Investigational Site
city: Székesfehérvár
country: Hungary
facility: GSK Investigational Site
city: Zalaegerszeg
country: Hungary
facility: GSK Investigational Site
city: Afula
country: Israel
facility: GSK Investigational Site
city: Ashkelon
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Kfar Saba
country: Israel
facility: GSK Investigational Site
city: Petach Tikva
country: Israel
facility: GSK Investigational Site
city: Safed
country: Israel
facility: GSK Investigational Site
city: Tel-Aviv
country: Israel
facility: GSK Investigational Site
city: Chieti Scalo
country: Italy
facility: GSK Investigational Site
state: Abruzzo
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Piacenza
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Rimini
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Pavia
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Palermo
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Firenze
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Padova
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Venezia
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Daugavpils
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
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city: Riga
country: Latvia
facility: GSK Investigational Site
city: Alkmaar
country: Netherlands
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city: Amsterdam
country: Netherlands
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city: Amsterdam
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city: Den Haag
country: Netherlands
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city: Maastricht
country: Netherlands
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city: Weerselo
country: Netherlands
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city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
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city: Gniewkowo
country: Poland
facility: GSK Investigational Site
city: Grudziadz
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
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city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Arkhangelsk
country: Russian Federation
facility: GSK Investigational Site
city: Barnaul
country: Russian Federation
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
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city: Irkutsk
country: Russian Federation
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city: Kemerovo
country: Russian Federation
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city: Kursk
country: Russian Federation
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city: Lipetsk
country: Russian Federation
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city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
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city: Perm
country: Russian Federation
facility: GSK Investigational Site
city: Perm
country: Russian Federation
facility: GSK Investigational Site
city: Rostov-na-Donu
country: Russian Federation
facility: GSK Investigational Site
city: Ryazan
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Samara
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburgh
country: Russian Federation
facility: GSK Investigational Site
city: Stavropol
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Tumen
country: Russian Federation
facility: GSK Investigational Site
city: Ufa
country: Russian Federation
facility: GSK Investigational Site
city: Voronezh
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Bardejov
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Kosice
country: Slovakia
facility: GSK Investigational Site
city: Kosice
country: Slovakia
facility: GSK Investigational Site
city: Nitra
country: Slovakia
facility: GSK Investigational Site
city: Presov
country: Slovakia
facility: GSK Investigational Site
city: Zilina
country: Slovakia
facility: GSK Investigational Site
city: Avila
country: Spain
facility: GSK Investigational Site
city: Boadilla del Monte (Madrid)
country: Spain
facility: GSK Investigational Site
city: Cartagena (Murcia)
country: Spain
facility: GSK Investigational Site
city: Getafe
country: Spain
facility: GSK Investigational Site
city: Gijon
country: Spain
facility: GSK Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: GSK Investigational Site
city: Marid
country: Spain
facility: GSK Investigational Site
city: Mataro
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Sabadell (Barcelona)
country: Spain
facility: GSK Investigational Site
city: San Juan De Alicante
country: Spain
facility: GSK Investigational Site
city: Segovia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valladolid
country: Spain
facility: GSK Investigational Site
city: Zamora
country: Spain
facility: GSK Investigational Site
city: Bern
country: Switzerland
facility: GSK Investigational Site
city: Bruderholz
country: Switzerland
facility: GSK Investigational Site
city: Fribourg
country: Switzerland
facility: GSK Investigational Site
city: Geneve
country: Switzerland
facility: GSK Investigational Site
city: Lausanne
country: Switzerland
facility: GSK Investigational Site
city: Luzern
country: Switzerland
facility: GSK Investigational Site
city: Zuerich
country: Switzerland
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Donetsk
country: Ukraine
facility: GSK Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Lviv
country: Ukraine
facility: GSK Investigational Site
city: Sevastopol
country: Ukraine
facility: GSK Investigational Site
city: Uzhgorod
country: Ukraine
facility: GSK Investigational Site
city: Vinnitsa
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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.
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.