A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

1,351

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

January 31, 2010

Study Completion Date

June 30, 2010

Conditions
Thrombosis, Venous
Interventions
DRUG

Fondaparinux sodium

After randomization (Day 1), subjects will receive subcutaneously once daily fondaparinux 2.5 mg \[0.5mL\] (1.5 mg \[0.3mL\] in patients with creatinine clearance between 30 and 50 mL/min) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days.

DRUG

Nadroparin

After randomization (Day 1), subjects will receive subcutaneously once daily nadroparin 2850 anti-Xa IU (0.3 mL) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days.

Trial Locations (122)

10043

GSK Investigational Site, Orbassano (TO)

10559

GSK Investigational Site, Berlin

12004

GSK Investigational Site, Castellon

12627

GSK Investigational Site, Berlin

13353

GSK Investigational Site, Berlin

14004

GSK Investigational Site, Córdoba

14400

GSK Investigational Site, Pozoblanco/Córdoba

15006

GSK Investigational Site, A Coruña

15405

GSK Investigational Site, Ferrol. La Coruña

15706

GSK Investigational Site, Santiago de Compostela

16132

GSK Investigational Site, Genoa

17108

GSK Investigational Site, Saintes

20161

GSK Investigational Site, Milan

20246

GSK Investigational Site, Hamburg

20500

GSK Investigational Site, Mondragón - Guipúzcoa

22415

GSK Investigational Site, Hamburg

23007

GSK Investigational Site, Jaén

23538

GSK Investigational Site, Lübeck

23700

GSK Investigational Site, Linares

24128

GSK Investigational Site, Bergamo

27004

GSK Investigational Site, Lugo

28006

GSK Investigational Site, Madrid

28023

GSK Investigational Site, Aravaca

28034

GSK Investigational Site, Madrid

28040

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28220

GSK Investigational Site, Majadahonda/Madrid

28250

GSK Investigational Site, Torrelodones/Madrid

28340

GSK Investigational Site, Valdemoro/Madrid

28905

GSK Investigational Site, Getafe/Madrid

29609

GSK Investigational Site, Brest

30625

GSK Investigational Site, Hanover

31015

GSK Investigational Site, Conegliano (TV)

31059

GSK Investigational Site, Toulouse

32005

GSK Investigational Site, Ourense

33100

GSK Investigational Site, Udine

33400

GSK Investigational Site, Avilés/Asturias

35033

GSK Investigational Site, Rennes

35128

GSK Investigational Site, Padua

36200

GSK Investigational Site, Vigo/Pontevedra

38043

GSK Investigational Site, Grenoble

39261

GSK Investigational Site, Zerbst

40136

GSK Investigational Site, Bologna

41071

GSK Investigational Site, Seville

42300

GSK Investigational Site, Roanne

44093

GSK Investigational Site, Nantes

47441

GSK Investigational Site, Moers

47923

GSK Investigational Site, Agen

49100

GSK Investigational Site, Angers

53100

GSK Investigational Site, Siena

58285

GSK Investigational Site, Gevelsberg

59037

GSK Investigational Site, Lille

59300

GSK Investigational Site, Valenciennes

60021

GSK Investigational Site, Beauvais

63000

GSK Investigational Site, Clermont-Ferrand

64301

GSK Investigational Site, Orthez

65191

GSK Investigational Site, Wiesbaden

68024

GSK Investigational Site, Colmar

69120

GSK Investigational Site, Heidelberg

69275

GSK Investigational Site, Lyon

69365

GSK Investigational Site, Lyon

69437

GSK Investigational Site, Lyon

69560

GSK Investigational Site, Sainte Colombe Les Vienne

74374

GSK Investigational Site, Pringy

75015

GSK Investigational Site, Paris

75181

GSK Investigational Site, Paris

75571

GSK Investigational Site, Paris

75651

GSK Investigational Site, Paris

75679

GSK Investigational Site, Paris

76031

GSK Investigational Site, Rouen

80335

GSK Investigational Site, Munich

80339

GSK Investigational Site, Munich

91054

GSK Investigational Site, Erlangen

92166

GSK Investigational Site, Antony

93009

GSK Investigational Site, Bobigny

94010

GSK Investigational Site, Créteil

95107

GSK Investigational Site, Argenteuil

95126

GSK Investigational Site, Catania

95303

GSK Investigational Site, Cergy-Pontoise

97448

GSK Investigational Site, Saint-Pierre

125299

GSK Investigational Site, Moscow

150003

GSK Investigational Site, Yaroslavl

150023

GSK Investigational Site, Yaroslavl

170036

GSK Investigational Site, Tver'

192242

GSK Investigational Site, Saint Petersburgh

198260

GSK Investigational Site, Saint Petersburg

305035

GSK Investigational Site, Kursk

340014

GSK Investigational Site, Palencia

355030

GSK Investigational Site, Stavropol

390026

GSK Investigational Site, Ryazan

443010

GSK Investigational Site, Samara

443095

GSK Investigational Site, Samara

450000

GSK Investigational Site, Ufa

614036

GSK Investigational Site, Perm

620039

GSK Investigational Site, Yekaterinburg

620102

GSK Investigational Site, Yekaterinburg

625023

GSK Investigational Site, Tyumen

630117

GSK Investigational Site, Novosibirsk

634063

GSK Investigational Site, Tomsk

650002

GSK Investigational Site, Kemerovo

656024

GSK Investigational Site, Barnaul

664003

GSK Investigational Site, Irkutsk

06250

GSK Investigational Site, Mougins

01187

GSK Investigational Site, Dresden

01307

GSK Investigational Site, Dresden

01762

GSK Investigational Site, Schmiedeberg

08060

GSK Investigational Site, Zwickau

04600

GSK Investigational Site, Altenburg

04100

GSK Investigational Site, Latina

00141

GSK Investigational Site, Rome

3818 ES

GSK Investigational Site, Amersfoort

5623 EJ

GSK Investigational Site, Eindhoven

6229 HX

GSK Investigational Site, Maastricht

6162 BG

GSK Investigational Site, Sittard-geleen

3582 KE

GSK Investigational Site, Utrecht

5912 BL

GSK Investigational Site, Venlo

08006

GSK Investigational Site, Barcelona

08036

GSK Investigational Site, Barcelona

06400

GSK Investigational Site, Don Benito/Badajoz

07010

GSK Investigational Site, Palma de Mallorca

Unknown

GSK Investigational Site, San Sebastián de Los Reyes/Madrid

03184

GSK Investigational Site, Torrevieja

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00843492 - A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery | Biotech Hunter | Biotech Hunter