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

NCT00443053 | Completed Phase 3 Results

• 1 other identifier: ART108053
• Study Type: interventional
• Target: 3,002
• Locations: 16 countries
• Sites: 212

Brief Summary

To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.

Conditions

Thrombosis, Venous

Keywords

superficial vein thrombosis; superficial thrombophlebitis; fondaparinux; deep vein thrombosis; venous thromboembolism treatment; thrombosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Day 47

Secondary Outcomes (6)

• Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77

  Baseline to Day 77

• Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77

  Days 47 and 77

• Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77

  Days 47 and 77

• Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77

  Days 47 (or last dose plus 4 days) and 77

• Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77

  Days 47 (or last dose plus 4 days) and 77

Study Arms (2)

Fondaparinux 2.5mg

ACTIVE COMPARATOR

Drug: Fondaparinux 2.5mg or placebo

Placebo

PLACEBO COMPARATOR

Drug: Fondaparinux 2.5mg or placebo

Interventions

Fondaparinux 2.5mg or placebo DRUG

Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day

Fondaparinux 2.5mg; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (227)

GSK Investigational Site

Sofia, 1309, Bulgaria

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Brno, 656 91, Czechia

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Olomouc, 775 20, Czechia

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Pilsen, 323 18, Czechia

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Prague, 101 00, Czechia

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Prague, 108 00, Czechia

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Prague, 12808, Czechia

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Prague, 140 00, Czechia

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Prague, 150 05, Czechia

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Prague, 169 02, Czechia

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Říčany, 251 01, Czechia

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GSK Investigational Site

Tábor, 390 03, Czechia

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Saku, 75501, Estonia

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GSK Investigational Site

Tallinn, 10138, Estonia

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Tallinn, 10617, Estonia

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GSK Investigational Site

Tartu, 50410, Estonia

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Abbeville, 80100, France

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Alès, 30100, France

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Amiens, 80054, France

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Annecy, 74000, France

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Annonay, 07100, France

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Arras, 62000, France

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Bordeaux, 33082, France

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Brest, 29200, France

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Clermont-Ferrand, 63000, France

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Grenoble, 38000, France

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Montpellier, 34295, France

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Nice, 06000, France

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Nîmes, 30029, France

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Saint-Aubin-sur-Scie, 76550, France

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Saint-Priest-en-Jarez, 42270, France

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Tarbes, 65000, France

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Toulon, 83000, France

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Toulouse, 31000, France

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Valenciennes, 59300, France

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Villeurbanne, 69100, France

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Baesweiler, Baden-Wurttemberg, 52499, Germany

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Freiburg im Breisgau, Baden-Wurttemberg, 79108, Germany

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Karlsbad, Baden-Wurttemberg, 76307, Germany

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Karlsruhe, Baden-Wurttemberg, 76133, Germany

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Lauffen am Neckar, Baden-Wurttemberg, 74348, Germany

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Augsburg, Bavaria, 86150, Germany

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Großheirath, Bavaria, 96269, Germany

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Hemau, Bavaria, 93155, Germany

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Munich, Bavaria, 80331, Germany

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Munich, Bavaria, 80333, Germany

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Munich, Bavaria, 80336, Germany

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Mühldorf, Bavaria, 84453, Germany

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Nördlingen, Bavaria, 86720, Germany

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Nuremberg, Bavaria, 90429, Germany

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Würzburg, Bavaria, 97070, Germany

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Dahlwitz-Hoppegarten, Brandenburg, 15366, Germany

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Potsdam, Brandenburg, 14482, Germany

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Hamburg, Hamburg, 22081, Germany

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Hamburg, Hamburg, 22143, Germany

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Hamburg, Hamburg, 22177, Germany

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Hamburg, Hamburg, 22761, Germany

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Darmstadt, Hesse, 64283, Germany

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Eschwege, Hesse, 37269, Germany

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Frankfurt am Main, Hesse, 60322, Germany

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Wiesbaden, Hesse, 65183, Germany

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Bad Bevensen, Lower Saxony, 29549, Germany

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Leer, Lower Saxony, 26789, Germany

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Osnabrück, Lower Saxony, 49074, Germany

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Rostock, Mecklenburg-Vorpommern, 18059, Germany

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Cologne, North Rhine-Westphalia, 50760, Germany

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Kettwig, North Rhine-Westphalia, 45219, Germany

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Koeln-Junkersdorf, North Rhine-Westphalia, 50858, Germany

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Mönchengladbach, North Rhine-Westphalia, 41065, Germany

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Neuss, North Rhine-Westphalia, 41460, Germany

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Oberhausen, North Rhine-Westphalia, 46145, Germany

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Waldbröl, North Rhine-Westphalia, 51545, Germany

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Wuppertal, North Rhine-Westphalia, 42275, Germany

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Frankenthal, Rhineland-Palatinate, 67227, Germany

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Ludwigshafen am Rhein, Rhineland-Palatinate, 67059, Germany

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Neustadt, Rhineland-Palatinate, 67434, Germany

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Neunkirchen, Saarland, 66538, Germany

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Chemnitz, Saxony, 09130, Germany

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Dresden, Saxony, 01309, Germany

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Kirchberg, Saxony, 08107, Germany

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Leipzig, Saxony, 04109, Germany

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Berlin, State of Berlin, 10559, Germany

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Berlin, State of Berlin, 10789, Germany

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Berlin, State of Berlin, 12627, Germany

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Altenburg, Thuringia, 04600, Germany

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Jena, Thuringia, 07743, Germany

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Nordhausen, Thuringia, 99734, Germany

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Alexandroupoli, 68100, Greece

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Athens, 115 27, Greece

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Athens, 145 61, Greece

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Heraklion, 712 01, Greece

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Larissa, 41110, Greece

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Melissia Athens, 15127, Greece

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Thessaloniki, 54642, Greece

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Thessaloniki, 56429, Greece

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Békéscsaba, 5600, Hungary

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Budapest, 1039, Hungary

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Budapest, 1081, Hungary

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Budapest, 1083, Hungary

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Budapest, 1096, Hungary

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Budapest, 1106, Hungary

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Budapest, 1115, Hungary

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Budapest, 1122, Hungary

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Debrecen, 4032, Hungary

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Esztergom, 2500, Hungary

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Gyula, 5700, Hungary

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Kaposvár, 7400, Hungary

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Miskolc, 3501, Hungary

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Nyiregyháza, 4400, Hungary

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Pécs, 7623, Hungary

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Székesfehérvár, 8000, Hungary

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Szikszó, 8300, Hungary

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Zalaegerszeg, 8900, Hungary

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Afula, 18101, Israel

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Ashkelon, 78306, Israel

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Haifa, 31096, Israel

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Kfar Saba, 44281, Israel

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Petah Tikva, 49100, Israel

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Safed, 13110, Israel

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Tel Aviv, 64239, Israel

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Chieti Scalo, Abruzzo, 66013, Italy

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Napoli, Campania, 80131, Italy

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Piacenza, Emilia-Romagna, 29100, Italy

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Reggio Emilia, Emilia-Romagna, 42100, Italy

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Rimini, Emilia-Romagna, 47900, Italy

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Milan, Lombardy, 20122, Italy

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Milan, Lombardy, 20132, Italy

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Milan, Lombardy, 20142, Italy

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Pavia, Lombardy, 27100, Italy

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Palermo, Sicily, 90126, Italy

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Florence, Tuscany, 50134, Italy

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Padua, Veneto, 35128, Italy

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Venezia, Veneto, 30122, Italy

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Daugavpils, LV5417, Latvia

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Riga, LV 1002, Latvia

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Riga, LV 1012, Latvia

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Riga, LV1038, Latvia

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Alkmaar, 1815 KX, Netherlands

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Amsterdam, 1066 EC, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Maastricht, 6229 HX, Netherlands

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The Hague, 2566 MJ, Netherlands

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Weerselo, 7651 JH, Netherlands

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Bialystok, 15-276, Poland

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Bydgoszcz, 85-168, Poland

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Gniewkowo, 88-140, Poland

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Grudziądz, 86-300, Poland

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Poznan, 61-848, Poland

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Wroclaw, 50-349, Poland

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Arkhangelsk, 163045, Russia

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Barnaul, 656038, Russia

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Irkutsk, 664003, Russia

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Kemerovo, 650002, Russia

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Kursk, 305035, Russia

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Lipetsk, 398055, Russia

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Moscow, 111538, Russia

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Moscow, 115 280, Russia

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Moscow, 119 048, Russia

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Moscow, 119049, Russia

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Moscow, 125299, Russia

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Moscow, 630117, Russia

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Moscow, Russia

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Perm, 614107, Russia

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Perm, 614990, Russia

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Rostov-on-Don, 344019, Russia

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Ryazan, 390026, Russia

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Saint Petersburg, 197046, Russia

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Saint Petersburg, 198260, Russia

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Saint Petersburgh, 192242, Russia

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Samara, 443099, Russia

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Saratov, 4100017, Russia

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Stavropol, 310, Russia

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Tomsk, 630117, Russia

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Tomsk, 634063, Russia

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Tyumen, 625023, Russia

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Ufa, 450000, Russia

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Voronezh, 394066, Russia

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Yaroslavl, 150003, Russia

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Yaroslavl, 150023, Russia

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Yekaterinburg, 620028, Russia

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Yekaterinburg, 620102, Russia

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Bardejov, 085 01, Slovakia

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Bratislava, 813 69, Slovakia

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Bratislava, 833 05, Slovakia

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Košice, 040 01, Slovakia

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Košice, 040 86, Slovakia

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Nitra, 949 01, Slovakia

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Prešov, 080 01, Slovakia

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Žilina, 010 01, Slovakia

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Ávila, 05071, Spain

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Boadilla Del Monte (Madrid), 28660, Spain

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Cartagena (Murcia), 30203, Spain

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Getafe, 28905, Spain

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Gijón, 33394, Spain

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L'Hospitalet de Llobregat, 08907, Spain

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Marid, 28040, Spain

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Mataró, 08034, Spain

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Palma de Mallorca, 07014, Spain

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Sabadell (Barcelona), 08208, Spain

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Sant Joan d'Alacant, 3550, Spain

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Segovia, 40002, Spain

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Valencia, 46017, Spain

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Valladolid, 47005, Spain

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Zamora, 49021, Spain

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Bern, 3010, Switzerland

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Bruderholz, 4101, Switzerland

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Fribourg, 1708, Switzerland

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Geneva, 1211, Switzerland

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Lausanne, 1005, Switzerland

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Lucerne, 6000, Switzerland

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Zurich, 8091, Switzerland

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Dnipropetrovsk, 49005, Ukraine

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Dnipropetrovsk, 49102, Ukraine

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Donetsk, 83045, Ukraine

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Ivano-Frankivsk, 76000, Ukraine

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Kharkiv, 61018, Ukraine

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Kyiv, 01601, Ukraine

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Kyiv, 03680, Ukraine

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Kyiv, 04201, Ukraine

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Lviv, 79010, Ukraine

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Sevastopol, 99011, Ukraine

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Uzhhorod, 88010, Ukraine

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Vinnitsa, 21018, Ukraine

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Zaporizhzhya, 69000, Ukraine

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Zaporizhzhya, 69065, Ukraine

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Zaporizhzhya, 69600, Ukraine

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Related Publications (2)

• 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.

  PMID: 23821661 DERIVED

• 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.

  PMID: 20860504 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Thrombosis

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Start: March 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 6, 2017
• Results First Posted: August 2, 2010

Record last verified: 2017-01

Locations

ES (4); NL (6); CZ (11); HU (18); UA (15); IT (13); BU (1); LA (4); CH (7); RU (32); DE (52); GR (8); IL (7); PL (6); SL (8); FR (20)