NCT00981409

Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Pulmonary Thromboembolism (PE)

Completed Phase 3 Results posted Last updated 4 November 2016

What this trial tests

Phase 3 trial testing Fondaparinux sodium in Embolism, Pulmonary in 41 participants. Completed in 1 December 2008.

Timeline

1 July 2007

Primary endpoint
1 December 2008

1 December 2008

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	1 July 2007
Primary completion	1 December 2008
Estimated completion	1 December 2008
Sites	27 locations across Japan

Drugs / interventions tested

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

Conditions studied

• Embolism, Pulmonary — all drugs for Embolism, Pulmonary →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

20 and older, any sex, with Embolism, Pulmonary. 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.

• The 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 thromboembolism \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).

Sponsor's own description

The primary objective 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 PE 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.