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AzTrials

Thrombosis, VenousPhase 3NCT00443053

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

A Phase 3 study of Thrombosis, Venous, run by GlaxoSmithKline at 227 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Thrombosis, Venous
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,002 participants
Where
227 sitesin 17 countries
Study dates
Mar 2007to Jul 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

227 sites in 17 countries.

227 sites in 17 countries

Germany52 sites

  • GSK Investigational Site

    Altenburg, Thuringia, 04600

  • GSK Investigational Site

    Augsburg, Bavaria, 86150

  • GSK Investigational Site

    Bad Bevensen, Lower Saxony, 29549

  • GSK Investigational Site

    Baesweiler, Baden-Wurttemberg, 52499

  • GSK Investigational Site

    Berlin, State of Berlin, 10559

  • GSK Investigational Site

    Berlin, State of Berlin, 10789

  • GSK Investigational Site

    Berlin, State of Berlin, 12627

  • GSK Investigational Site

    Chemnitz, Saxony, 09130

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50760

  • GSK Investigational Site

    Dahlwitz-Hoppegarten, Brandenburg, 15366

  • GSK Investigational Site

    Darmstadt, Hesse, 64283

  • GSK Investigational Site

    Dresden, Saxony, 01309

  • GSK Investigational Site

    Eschwege, Hesse, 37269

  • GSK Investigational Site

    Frankenthal, Rhineland-Palatinate, 67227

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60322

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79108

  • GSK Investigational Site

    Großheirath, Bavaria, 96269

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22081

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22143

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22177

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22761

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • GSK Investigational Site

    Hemau, Bavaria, 93155

  • GSK Investigational Site

    Jena, Thuringia, 07743

  • GSK Investigational Site

    Karlsbad, Baden-Wurttemberg, 76307

  • GSK Investigational Site

    Karlsruhe, Baden-Wurttemberg, 76133

  • GSK Investigational Site

    Kettwig, North Rhine-Westphalia, 45219

  • GSK Investigational Site

    Kirchberg, Saxony, 08107

  • GSK Investigational Site

    Koeln-Junkersdorf, North Rhine-Westphalia, 50858

  • GSK Investigational Site

    Lauffen am Neckar, Baden-Wurttemberg, 74348

  • GSK Investigational Site

    Leer, Lower Saxony, 26789

  • GSK Investigational Site

    Leipzig, Saxony, 04109

  • GSK Investigational Site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67059

  • GSK Investigational Site

    Mönchengladbach, North Rhine-Westphalia, 41065

  • GSK Investigational Site

    Mühldorf, Bavaria, 84453

  • GSK Investigational Site

    Munich, Bavaria, 80331

  • GSK Investigational Site

    Munich, Bavaria, 80333

  • GSK Investigational Site

    Munich, Bavaria, 80336

  • GSK Investigational Site

    Neunkirchen, Saarland, 66538

  • GSK Investigational Site

    Neuss, North Rhine-Westphalia, 41460

  • GSK Investigational Site

    Neustadt, Rhineland-Palatinate, 67434

  • GSK Investigational Site

    Nordhausen, Thuringia, 99734

  • GSK Investigational Site

    Nördlingen, Bavaria, 86720

  • GSK Investigational Site

    Nuremberg, Bavaria, 90429

  • GSK Investigational Site

    Oberhausen, North Rhine-Westphalia, 46145

  • GSK Investigational Site

    Osnabrück, Lower Saxony, 49074

  • GSK Investigational Site

    Potsdam, Brandenburg, 14482

  • GSK Investigational Site

    Rostock, Mecklenburg-Vorpommern, 18059

  • GSK Investigational Site

    Waldbröl, North Rhine-Westphalia, 51545

  • GSK Investigational Site

    Wiesbaden, Hesse, 65183

  • GSK Investigational Site

    Wuppertal, North Rhine-Westphalia, 42275

  • GSK Investigational Site

    Würzburg, Bavaria, 97070

Other trials in Germany

Russia32 sites

  • GSK Investigational Site

    Arkhangelsk, 163045

  • GSK Investigational Site

    Barnaul, 656038

  • GSK Investigational Site

    Irkutsk, 664003

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Kursk, 305035

  • GSK Investigational Site

    Lipetsk, 398055

  • GSK Investigational Site

    Moscow, 111538

  • GSK Investigational Site

    Moscow, 115 280

  • GSK Investigational Site

    Moscow, 119 048

  • GSK Investigational Site

    Moscow, 119049

  • GSK Investigational Site

    Moscow, 125299

  • GSK Investigational Site

    Moscow, 630117

  • GSK Investigational Site

    Moscow

  • GSK Investigational Site

    Perm, 614107

  • GSK Investigational Site

    Perm, 614990

  • GSK Investigational Site

    Rostov-on-Don, 344019

  • GSK Investigational Site

    Ryazan, 390026

  • GSK Investigational Site

    Saint Petersburg, 197046

  • GSK Investigational Site

    Saint Petersburg, 198260

  • GSK Investigational Site

    Saint Petersburgh, 192242

  • GSK Investigational Site

    Samara, 443099

  • GSK Investigational Site

    Saratov, 4100017

  • GSK Investigational Site

    Stavropol, 310

  • GSK Investigational Site

    Tomsk, 630117

  • GSK Investigational Site

    Tomsk, 634063

  • GSK Investigational Site

    Tyumen, 625023

  • GSK Investigational Site

    Ufa, 450000

  • GSK Investigational Site

    Voronezh, 394066

  • GSK Investigational Site

    Yaroslavl, 150003

  • GSK Investigational Site

    Yaroslavl, 150023

  • GSK Investigational Site

    Yekaterinburg, 620028

  • GSK Investigational Site

    Yekaterinburg, 620102

Other trials in Russia

France20 sites

  • GSK Investigational Site

    Abbeville, 80100

  • GSK Investigational Site

    Alès, 30100

  • GSK Investigational Site

    Amiens, 80054

  • GSK Investigational Site

    Annecy, 74000

  • GSK Investigational Site

    Annonay, 07100

  • GSK Investigational Site

    Arras, 62000

  • GSK Investigational Site

    Bordeaux, 33082

  • GSK Investigational Site

    Brest, 29200

  • GSK Investigational Site

    Clermont-Ferrand, 63000

  • GSK Investigational Site

    Grenoble, 38000

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Nice, 06000

  • GSK Investigational Site

    Nîmes, 30029

  • GSK Investigational Site

    Saint-Aubin-sur-Scie, 76550

  • GSK Investigational Site

    Saint-Priest-en-Jarez, 42270

  • GSK Investigational Site

    Tarbes, 65000

  • GSK Investigational Site

    Toulon, 83000

  • GSK Investigational Site

    Toulouse, 31000

  • GSK Investigational Site

    Valenciennes, 59300

  • GSK Investigational Site

    Villeurbanne, 69100

Other trials in France

Hungary18 sites

  • GSK Investigational Site

    Békéscsaba, 5600

  • GSK Investigational Site

    Budapest, 1039

  • GSK Investigational Site

    Budapest, 1081

  • GSK Investigational Site

    Budapest, 1083

  • GSK Investigational Site

    Budapest, 1096

  • GSK Investigational Site

    Budapest, 1106

  • GSK Investigational Site

    Budapest, 1115

  • GSK Investigational Site

    Budapest, 1122

  • GSK Investigational Site

    Debrecen, 4032

  • GSK Investigational Site

    Esztergom, 2500

  • GSK Investigational Site

    Gyula, 5700

  • GSK Investigational Site

    Kaposvár, 7400

  • GSK Investigational Site

    Miskolc, 3501

  • GSK Investigational Site

    Nyiregyháza, 4400

  • GSK Investigational Site

    Pécs, 7623

  • GSK Investigational Site

    Székesfehérvár, 8000

  • GSK Investigational Site

    Szikszó, 8300

  • GSK Investigational Site

    Zalaegerszeg, 8900

Other trials in Hungary

Spain15 sites

  • GSK Investigational Site

    Ávila, 05071

  • GSK Investigational Site

    Boadilla Del Monte (Madrid), 28660

  • GSK Investigational Site

    Cartagena (Murcia), 30203

  • GSK Investigational Site

    Getafe, 28905

  • GSK Investigational Site

    Gijón, 33394

  • GSK Investigational Site

    L'Hospitalet de Llobregat, 08907

  • GSK Investigational Site

    Marid, 28040

  • GSK Investigational Site

    Mataró, 08034

  • GSK Investigational Site

    Palma de Mallorca, 07014

  • GSK Investigational Site

    Sabadell (Barcelona), 08208

  • GSK Investigational Site

    Sant Joan d'Alacant, 3550

  • GSK Investigational Site

    Segovia, 40002

  • GSK Investigational Site

    Valencia, 46017

  • GSK Investigational Site

    Valladolid, 47005

  • GSK Investigational Site

    Zamora, 49021

Other trials in Spain

Ukraine15 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49005

  • GSK Investigational Site

    Dnipropetrovsk, 49102

  • GSK Investigational Site

    Donetsk, 83045

  • GSK Investigational Site

    Ivano-Frankivsk, 76000

  • GSK Investigational Site

    Kharkiv, 61018

  • GSK Investigational Site

    Kyiv, 01601

  • GSK Investigational Site

    Kyiv, 03680

  • GSK Investigational Site

    Kyiv, 04201

  • GSK Investigational Site

    Lviv, 79010

  • GSK Investigational Site

    Sevastopol, 99011

  • GSK Investigational Site

    Uzhhorod, 88010

  • GSK Investigational Site

    Vinnitsa, 21018

  • GSK Investigational Site

    Zaporizhzhya, 69000

  • GSK Investigational Site

    Zaporizhzhya, 69065

  • GSK Investigational Site

    Zaporizhzhya, 69600

Other trials in Ukraine

Italy13 sites

  • GSK Investigational Site

    Chieti Scalo, Abruzzo, 66013

  • GSK Investigational Site

    Florence, Tuscany, 50134

  • GSK Investigational Site

    Milan, Lombardy, 20122

  • GSK Investigational Site

    Milan, Lombardy, 20132

  • GSK Investigational Site

    Milan, Lombardy, 20142

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Padova, Veneto, 35128

  • GSK Investigational Site

    Palermo, Sicily, 90126

  • GSK Investigational Site

    Pavia, Lombardy, 27100

  • GSK Investigational Site

    Piacenza, Emilia-Romagna, 29100

  • GSK Investigational Site

    Reggio Emilia, Emilia-Romagna, 42100

  • GSK Investigational Site

    Rimini, Emilia-Romagna, 47900

  • GSK Investigational Site

    Venezia, Veneto, 30122

Other trials in Italy

Czechia11 sites

  • GSK Investigational Site

    Brno, 656 91

  • GSK Investigational Site

    Olomouc, 775 20

  • GSK Investigational Site

    Pilsen, 323 18

  • GSK Investigational Site

    Prague, 101 00

  • GSK Investigational Site

    Prague, 108 00

  • GSK Investigational Site

    Prague, 12808

  • GSK Investigational Site

    Prague, 140 00

  • GSK Investigational Site

    Prague, 150 05

  • GSK Investigational Site

    Prague, 169 02

  • GSK Investigational Site

    Říčany, 251 01

  • GSK Investigational Site

    Tábor, 390 03

Other trials in Czechia

Greece8 sites

  • GSK Investigational Site

    Alexandroupoli, 68100

  • GSK Investigational Site

    Athens, 115 27

  • GSK Investigational Site

    Athens, 145 61

  • GSK Investigational Site

    Heraklion, 712 01

  • GSK Investigational Site

    Larissa, 41110

  • GSK Investigational Site

    Melissia Athens, 15127

  • GSK Investigational Site

    Thessaloniki, 54642

  • GSK Investigational Site

    Thessaloniki, 56429

Other trials in Greece

Slovakia8 sites

  • GSK Investigational Site

    Bardejov, 085 01

  • GSK Investigational Site

    Bratislava, 813 69

  • GSK Investigational Site

    Bratislava, 833 05

  • GSK Investigational Site

    Košice, 040 01

  • GSK Investigational Site

    Košice, 040 86

  • GSK Investigational Site

    Nitra, 949 01

  • GSK Investigational Site

    Prešov, 080 01

  • GSK Investigational Site

    Žilina, 010 01

Other trials in Slovakia

Israel7 sites

  • GSK Investigational Site

    Afula, 18101

  • GSK Investigational Site

    Ashkelon, 78306

  • GSK Investigational Site

    Haifa, 31096

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Petah Tikva, 49100

  • GSK Investigational Site

    Safed, 13110

  • GSK Investigational Site

    Tel Aviv, 64239

Other trials in Israel

Switzerland7 sites

  • GSK Investigational Site

    Bern, 3010

  • GSK Investigational Site

    Bruderholz, 4101

  • GSK Investigational Site

    Fribourg, 1708

  • GSK Investigational Site

    Geneva, 1211

  • GSK Investigational Site

    Lausanne, 1005

  • GSK Investigational Site

    Lucerne, 6000

  • GSK Investigational Site

    Zurich, 8091

Other trials in Switzerland

Netherlands6 sites

  • GSK Investigational Site

    Alkmaar, 1815 KX

  • GSK Investigational Site

    Amsterdam, 1066 EC

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Maastricht, 6229 HX

  • GSK Investigational Site

    The Hague, 2566 MJ

  • GSK Investigational Site

    Weerselo, 7651 JH

Other trials in Netherlands

Poland6 sites

  • GSK Investigational Site

    Bialystok, 15-276

  • GSK Investigational Site

    Bydgoszcz, 85-168

  • GSK Investigational Site

    Gniewkowo, 88-140

  • GSK Investigational Site

    Grudziądz, 86-300

  • GSK Investigational Site

    Poznan, 61-848

  • GSK Investigational Site

    Wroclaw, 50-349

Other trials in Poland

Estonia4 sites

  • GSK Investigational Site

    Saku, 75501

  • GSK Investigational Site

    Tallinn, 10138

  • GSK Investigational Site

    Tallinn, 10617

  • GSK Investigational Site

    Tartu, 50410

Other trials in Estonia

Latvia4 sites

  • GSK Investigational Site

    Daugavpils, LV5417

  • GSK Investigational Site

    Riga, LV 1002

  • GSK Investigational Site

    Riga, LV 1012

  • GSK Investigational Site

    Riga, LV1038

Other trials in Latvia

Bulgaria1 site

  • GSK Investigational Site

    Sofia, 1309

Other trials in Bulgaria

About this study

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

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

Read the 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

Being tested
Fondaparinux 2.5mg or placebo
Keywords
superficial vein thrombosis, superficial thrombophlebitis, fondaparinux, deep vein thrombosis, venous thromboembolism treatment, thrombosis
Medical subject headings
Venous Thrombosis, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fondaparinux 2.5mg or placeboDrug

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

Study groups in NCT00443053
Study groupRoleWhat they receive
Fondaparinux 2.5mgActive comparatorNot described
Receives: Drug: Fondaparinux 2.5mg or placebo
PlaceboPlacebo comparatorNot described
Receives: Drug: Fondaparinux 2.5mg or placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Day 47

Secondary outcomes (6)

  1. 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.

    Measured: Baseline to Day 77

  2. 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.

    Measured: Days 47 and 77

  3. 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.

    Measured: Days 47 and 77

  4. 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.

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

  5. 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.

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

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
3,002 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00443053
Sponsor's protocol ID
ART108053
Status last verified
Jan 2017
First submitted
2 Mar 2007
Last updated
6 Mar 2017

Publications

  • 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.

    PubMed 23821661

  • 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.

    PubMed 20860504

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Thrombosis, Venous, run by GlaxoSmithKline at 227 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 sites in Germany, Russia, France, Hungary, Spain and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00443053, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.

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