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

January 20, 2017 updated by: GlaxoSmithKline

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3002

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1309
        • GSK Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 656 91
        • GSK Investigational Site
      • Olomouc, Czech Republic, 775 20
        • GSK Investigational Site
      • Plzen, Czech Republic, 323 18
        • GSK Investigational Site
      • Praha 10, Czech Republic, 101 00
        • GSK Investigational Site
      • Praha 10, Czech Republic, 108 00
        • GSK Investigational Site
      • Praha 2, Czech Republic, 12808
        • GSK Investigational Site
      • Praha 4, Czech Republic, 140 00
        • GSK Investigational Site
      • Praha 5, Czech Republic, 150 05
        • GSK Investigational Site
      • Praha 6, Czech Republic, 169 02
        • GSK Investigational Site
      • Ricany, Czech Republic, 251 01
        • GSK Investigational Site
      • Tabor, Czech Republic, 390 03
        • GSK Investigational Site
  • Estonia
      • Saku, Estonia, 75501
        • GSK Investigational Site
      • Tallinn, Estonia, 10617
        • GSK Investigational Site
      • Tallinn, Estonia, 10138
        • GSK Investigational Site
      • Tartu, Estonia, 50410
        • GSK Investigational Site
  • France
      • Abbeville, France, 80100
        • GSK Investigational Site
      • Ales, France, 30100
        • GSK Investigational Site
      • Amiens, France, 80054
        • GSK Investigational Site
      • Annecy, France, 74000
        • GSK Investigational Site
      • Annonay, France, 07100
        • GSK Investigational Site
      • Arras, France, 62000
        • GSK Investigational Site
      • Bordeaux, France, 33082
        • GSK Investigational Site
      • Brest, France, 29200
        • GSK Investigational Site
      • Clermont Ferrand, France, 63000
        • GSK Investigational Site
      • Grenoble, France, 38000
        • GSK Investigational Site
      • Montpellier, France, 34295
        • GSK Investigational Site
      • Nice, France, 06000
        • GSK Investigational Site
      • Nîmes Cedex 9, France, 30029
        • GSK Investigational Site
      • Saint Aubin sur Scie, France, 76550
        • GSK Investigational Site
      • Saint-Priest en Jarez, France, 42270
        • GSK Investigational Site
      • Tarbes, France, 65000
        • GSK Investigational Site
      • Toulon, France, 83000
        • GSK Investigational Site
      • Toulouse, France, 31000
        • GSK Investigational Site
      • Valenciennes, France, 59300
        • GSK Investigational Site
      • Villeurbanne, France, 69100
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10789
        • GSK Investigational Site
      • Berlin, Germany, 10559
        • GSK Investigational Site
      • Berlin, Germany, 12627
        • GSK Investigational Site
      • Hamburg, Germany, 22143
        • GSK Investigational Site
      • Hamburg, Germany, 22081
        • GSK Investigational Site
      • Hamburg, Germany, 22177
        • GSK Investigational Site
      • Hamburg, Germany, 22761
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Baesweiler, Baden-Wuerttemberg, Germany, 52499
        • GSK Investigational Site
      • Freiburg, Baden-Wuerttemberg, Germany, 79108
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • GSK Investigational Site
      • Karlsbad, Baden-Wuerttemberg, Germany, 76307
        • GSK Investigational Site
      • Karlsruhe, Baden-Wuerttemberg, Germany, 76133
        • GSK Investigational Site
      • Lauffen, Baden-Wuerttemberg, Germany, 74348
        • GSK Investigational Site
    • Bayern
      • Augsburg, Bayern, Germany, 86150
        • GSK Investigational Site
      • Grossheirath, Bayern, Germany, 96269
        • GSK Investigational Site
      • Hemau, Bayern, Germany, 93155
        • GSK Investigational Site
      • Muehldorf, Bayern, Germany, 84453
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80336
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80333
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80331
        • GSK Investigational Site
      • Noerdlingen, Bayern, Germany, 86720
        • GSK Investigational Site
      • Nuernberg, Bayern, Germany, 90429
        • GSK Investigational Site
      • Wuerzburg, Bayern, Germany, 97070
        • GSK Investigational Site
    • Brandenburg
      • Dahlwitz-Hoppegarten, Brandenburg, Germany, 15366
        • GSK Investigational Site
      • Potsdam, Brandenburg, Germany, 14482
        • GSK Investigational Site
    • Hessen
      • Darmstadt, Hessen, Germany, 64283
        • GSK Investigational Site
      • Eschwege, Hessen, Germany, 37269
        • GSK Investigational Site
      • Frankfurt, Hessen, Germany, 60322
        • GSK Investigational Site
      • Wiesbaden, Hessen, Germany, 65183
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18059
        • GSK Investigational Site
    • Niedersachsen
      • Bad Bevensen, Niedersachsen, Germany, 29549
        • GSK Investigational Site
      • Leer, Niedersachsen, Germany, 26789
        • GSK Investigational Site
      • Osnabrueck, Niedersachsen, Germany, 49074
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen-Kettwig, Nordrhein-Westfalen, Germany, 45219
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 50760
        • GSK Investigational Site
      • Koeln-Junkersdorf, Nordrhein-Westfalen, Germany, 50858
        • GSK Investigational Site
      • Moenchengladbach, Nordrhein-Westfalen, Germany, 41065
        • GSK Investigational Site
      • Neuss, Nordrhein-Westfalen, Germany, 41460
        • GSK Investigational Site
      • Oberhausen, Nordrhein-Westfalen, Germany, 46145
        • GSK Investigational Site
      • Waldbroel, Nordrhein-Westfalen, Germany, 51545
        • GSK Investigational Site
      • Wuppertal, Nordrhein-Westfalen, Germany, 42275
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Frankenthal, Rheinland-Pfalz, Germany, 67227
        • GSK Investigational Site
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67059
        • GSK Investigational Site
      • Neustadt, Rheinland-Pfalz, Germany, 67434
        • GSK Investigational Site
    • Saarland
      • Neunkirchen, Saarland, Germany, 66538
        • GSK Investigational Site
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09130
        • GSK Investigational Site
      • Dresden, Sachsen, Germany, 01309
        • GSK Investigational Site
      • Kirchberg, Sachsen, Germany, 08107
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04109
        • GSK Investigational Site
    • Thueringen
      • Altenburg, Thueringen, Germany, 04600
        • GSK Investigational Site
      • Jena, Thueringen, Germany, 07743
        • GSK Investigational Site
      • Nordhausen, Thueringen, Germany, 99734
        • GSK Investigational Site
  • Greece
      • Alexandroupolis, Greece, 68100
        • GSK Investigational Site
      • Athens, Greece, 115 27
        • GSK Investigational Site
      • Athens, Greece, 145 61
        • GSK Investigational Site
      • Heraklion, Greece, 712 01
        • GSK Investigational Site
      • Larisa, Greece, 41110
        • GSK Investigational Site
      • Melissia Athens, Greece, 15127
        • GSK Investigational Site
      • Thessaloniki, Greece, 54642
        • GSK Investigational Site
      • Thessaloniki, Greece, 56429
        • GSK Investigational Site
  • Hungary
      • Bekescsaba, Hungary, 5600
        • GSK Investigational Site
      • Budapest, Hungary, 1083
        • GSK Investigational Site
      • Budapest, Hungary, 1122
        • GSK Investigational Site
      • Budapest, Hungary, 1096
        • GSK Investigational Site
      • Budapest, Hungary, 1106
        • GSK Investigational Site
      • Budapest, Hungary, 1039
        • GSK Investigational Site
      • Budapest, Hungary, 1115
        • GSK Investigational Site
      • Budapest, Hungary, 1081
        • GSK Investigational Site
      • Debrecen, Hungary, 4032
        • GSK Investigational Site
      • Esztergom, Hungary, 2500
        • GSK Investigational Site
      • Gyula, Hungary, 5700
        • GSK Investigational Site
      • Kaposvár, Hungary, 7400
        • GSK Investigational Site
      • Miskolc, Hungary, 3501
        • GSK Investigational Site
      • Nyiregyháza, Hungary, 4400
        • GSK Investigational Site
      • Pécs, Hungary, 7623
        • GSK Investigational Site
      • Szikszó, Hungary, 8300
        • GSK Investigational Site
      • Székesfehérvár, Hungary, 8000
        • GSK Investigational Site
      • Zalaegerszeg, Hungary, 8900
        • GSK Investigational Site
  • Israel
      • Afula, Israel, 18101
        • GSK Investigational Site
      • Ashkelon, Israel, 78306
        • GSK Investigational Site
      • Haifa, Israel, 31096
        • GSK Investigational Site
      • Kfar Saba, Israel, 44281
        • GSK Investigational Site
      • Petach Tikva, Israel, 49100
        • GSK Investigational Site
      • Safed, Israel, 13110
        • GSK Investigational Site
      • Tel-Aviv, Israel, 64239
        • GSK Investigational Site
  • Italy
    • Abruzzo
      • Chieti Scalo, Abruzzo, Italy, 66013
        • GSK Investigational Site
    • Campania
      • Napoli, Campania, Italy, 80131
        • GSK Investigational Site
    • Emilia-Romagna
      • Piacenza, Emilia-Romagna, Italy, 29100
        • GSK Investigational Site
      • Reggio Emilia, Emilia-Romagna, Italy, 42100
        • GSK Investigational Site
      • Rimini, Emilia-Romagna, Italy, 47900
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20122
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20142
        • GSK Investigational Site
      • Pavia, Lombardia, Italy, 27100
        • GSK Investigational Site
    • Sicilia
      • Palermo, Sicilia, Italy, 90126
        • GSK Investigational Site
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • GSK Investigational Site
    • Veneto
      • Padova, Veneto, Italy, 35128
        • GSK Investigational Site
      • Venezia, Veneto, Italy, 30122
        • GSK Investigational Site
  • Latvia
      • Daugavpils, Latvia, LV5417
        • GSK Investigational Site
      • Riga, Latvia, LV 1002
        • GSK Investigational Site
      • Riga, Latvia, LV1038
        • GSK Investigational Site
      • Riga, Latvia, LV 1012
        • GSK Investigational Site
  • Netherlands
      • Alkmaar, Netherlands, 1815 KX
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1105 AZ
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1066 EC
        • GSK Investigational Site
      • Den Haag, Netherlands, 2566 MJ
        • GSK Investigational Site
      • Maastricht, Netherlands, 6229 HX
        • GSK Investigational Site
      • Weerselo, Netherlands, 7651 JH
        • GSK Investigational Site
  • Poland
      • Bialystok, Poland, 15-276
        • GSK Investigational Site
      • Bydgoszcz, Poland, 85-168
        • GSK Investigational Site
      • Gniewkowo, Poland, 88-140
        • GSK Investigational Site
      • Grudziadz, Poland, 86-300
        • GSK Investigational Site
      • Poznan, Poland, 61-848
        • GSK Investigational Site
      • Wroclaw, Poland, 50-349
        • GSK Investigational Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • GSK Investigational Site
      • Barnaul, Russian Federation, 656038
        • GSK Investigational Site
      • Ekaterinburg, Russian Federation, 620102
        • GSK Investigational Site
      • Ekaterinburg, Russian Federation, 620028
        • GSK Investigational Site
      • Irkutsk, Russian Federation, 664003
        • GSK Investigational Site
      • Kemerovo, Russian Federation, 650002
        • GSK Investigational Site
      • Kursk, Russian Federation, 305035
        • GSK Investigational Site
      • Lipetsk, Russian Federation, 398055
        • GSK Investigational Site
      • Moscow, Russian Federation, 119049
        • GSK Investigational Site
      • Moscow, Russian Federation
        • GSK Investigational Site
      • Moscow, Russian Federation, 115 280
        • GSK Investigational Site
      • Moscow, Russian Federation, 111538
        • GSK Investigational Site
      • Moscow, Russian Federation, 125299
        • GSK Investigational Site
      • Moscow, Russian Federation, 119 048
        • GSK Investigational Site
      • Moscow, Russian Federation, 630117
        • GSK Investigational Site
      • Perm, Russian Federation, 614107
        • GSK Investigational Site
      • Perm, Russian Federation, 614990
        • GSK Investigational Site
      • Rostov-na-Donu, Russian Federation, 344019
        • GSK Investigational Site
      • Ryazan, Russian Federation, 390026
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 198260
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 197046
        • GSK Investigational Site
      • Samara, Russian Federation, 443099
        • GSK Investigational Site
      • Saratov, Russian Federation, 4100017
        • GSK Investigational Site
      • St. Petersburgh, Russian Federation, 192242
        • GSK Investigational Site
      • Stavropol, Russian Federation, 310
        • GSK Investigational Site
      • Tomsk, Russian Federation, 634063
        • GSK Investigational Site
      • Tomsk, Russian Federation, 630117
        • GSK Investigational Site
      • Tumen, Russian Federation, 625023
        • GSK Investigational Site
      • Ufa, Russian Federation, 450000
        • GSK Investigational Site
      • Voronezh, Russian Federation, 394066
        • GSK Investigational Site
      • Yaroslavl, Russian Federation, 150003
        • GSK Investigational Site
      • Yaroslavl, Russian Federation, 150023
        • GSK Investigational Site
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • GSK Investigational Site
      • Bratislava, Slovakia, 813 69
        • GSK Investigational Site
      • Bratislava, Slovakia, 833 05
        • GSK Investigational Site
      • Kosice, Slovakia, 040 01
        • GSK Investigational Site
      • Kosice, Slovakia, 040 86
        • GSK Investigational Site
      • Nitra, Slovakia, 949 01
        • GSK Investigational Site
      • Presov, Slovakia, 080 01
        • GSK Investigational Site
      • Zilina, Slovakia, 010 01
        • GSK Investigational Site
  • Spain
      • Avila, Spain, 05071
        • GSK Investigational Site
      • Boadilla del Monte (Madrid), Spain, 28660
        • GSK Investigational Site
      • Cartagena (Murcia), Spain, 30203
        • GSK Investigational Site
      • Getafe, Spain, 28905
        • GSK Investigational Site
      • Gijon, Spain, 33394
        • GSK Investigational Site
      • Hospitalet de Llobregat, Spain, 08907
        • GSK Investigational Site
      • Marid, Spain, 28040
        • GSK Investigational Site
      • Mataro, Spain, 08034
        • GSK Investigational Site
      • Palma de Mallorca, Spain, 07014
        • GSK Investigational Site
      • Sabadell (Barcelona), Spain, 08208
        • GSK Investigational Site
      • San Juan De Alicante, Spain, 3550
        • GSK Investigational Site
      • Segovia, Spain, 40002
        • GSK Investigational Site
      • Valencia, Spain, 46017
        • GSK Investigational Site
      • Valladolid, Spain, 47005
        • GSK Investigational Site
      • Zamora, Spain, 49021
        • GSK Investigational Site
  • Switzerland
      • Bern, Switzerland, 3010
        • GSK Investigational Site
      • Bruderholz, Switzerland, 4101
        • GSK Investigational Site
      • Fribourg, Switzerland, 1708
        • GSK Investigational Site
      • Geneve, Switzerland, 1211
        • GSK Investigational Site
      • Lausanne, Switzerland, 1005
        • GSK Investigational Site
      • Luzern, Switzerland, 6000
        • GSK Investigational Site
      • Zuerich, Switzerland, 8091
        • GSK Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • GSK Investigational Site
      • Dnipropetrovsk, Ukraine, 49005
        • GSK Investigational Site
      • Donetsk, Ukraine, 83045
        • GSK Investigational Site
      • Ivano-Frankivsk, Ukraine, 76000
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61018
        • GSK Investigational Site
      • Kyiv, Ukraine, 03680
        • GSK Investigational Site
      • Kyiv, Ukraine, 01601
        • GSK Investigational Site
      • Kyiv, Ukraine, 04201
        • GSK Investigational Site
      • Lviv, Ukraine, 79010
        • GSK Investigational Site
      • Sevastopol, Ukraine, 99011
        • GSK Investigational Site
      • Uzhgorod, Ukraine, 88010
        • GSK Investigational Site
      • Vinnitsa, Ukraine, 21018
        • GSK Investigational Site
      • Zaporizhzhya, Ukraine, 69000
        • GSK Investigational Site
      • Zaporizhzhya, Ukraine, 69600
        • GSK Investigational Site
      • Zaporizhzhya, Ukraine, 69065
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Fondaparinux 2.5mg or placebo
Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day
ACTIVE_COMPARATOR: Fondaparinux 2.5mg
Drug: Fondaparinux 2.5mg or placebo
Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77
Time Frame: Baseline to Day 77
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 77
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77
Time Frame: Days 47 and 77
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.
Days 47 and 77
Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77
Time Frame: Days 47 and 77
The number of participants requiring surgery was measured.
Days 47 and 77
Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77
Time Frame: Days 47 (or last dose plus 4 days) and 77
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.
Days 47 (or last dose plus 4 days) and 77
Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77
Time Frame: Days 47 (or last dose plus 4 days) 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.
Days 47 (or last dose plus 4 days) and 77
Number of Any Adjudicated Bleeding Events at Days 47 and 77
Time Frame: Days 47 (or last dose plus 4 days) 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.
Days 47 (or last dose plus 4 days) and 77

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2007

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ART108053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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