NCT00911157

Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Deep Vein Thrombosis (DVT)

Completed Phase 3 Results posted Last updated 11 October 2016

What this trial tests

Phase 3 trial testing Fondaparinux sodium in Thrombosis, Venous in 39 participants. Completed in 1 November 2009.

Timeline

1 June 2008

Primary endpoint
1 November 2009

1 November 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	1 June 2008
Primary completion	1 November 2009
Estimated completion	1 November 2009
Sites	24 locations across Japan

Drugs / interventions tested

• Fondaparinux sodium — full drug profile →
• unfractionated heparin (UFH)

Conditions studied

• Thrombosis, Venous — all drugs for Thrombosis, Venous →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

20 and older, any sex, with Thrombosis, Venous. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)
  Time frame: From Day 1 to Day 90 (±7 days)
  VTE (pulmonary thromboembolism \[PE\] and/or deep vein thrombosis \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).

Sponsor's own description

The primary objective of this study is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute symptomatic DVT in an open-label design.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.