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ARIXTRA® Adherence in SVT Patients.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01691495
First received: September 20, 2012
Last updated: January 31, 2013
Last verified: September 2012
History of Changes

September 20, 2012
January 31, 2013
November 2012
October 2014   (final data collection date for primary outcome measure)
The primary outcome will be a measure of physician adherence. [ Time Frame: 2 ] [ Designated as safety issue: No ]
adherence described as the percentage of patients for whom both an ultrasound (or other objective measure) was performed in order to rule out concomitant DVT prior to patients commencing fondaparinux
Same as current
Complete list of historical versions of study NCT01691495 on ClinicalTrials.gov Archive Site
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ARIXTRA® Adherence in SVT Patients.
ARIXTRA® Physician Adherence to the Prescribing Information in Isolated Superficial Vein Thrombosis (SVT) Patients.

Fondaparinux is an anticoagulant used in the prevention and treatment of thromboembolic disease. It has recently been approved in the European Union (EU) for the treatment of patients with isolated superficial vein thrombosis (SVT), i.e. without concomitant deep vein thrombosis (DVT), of the lower limbs. As part of EU approval, GlaxoSmithKline (GSK) committed to evaluate physicians' adherence to fondaparinux prescribing information regarding proper diagnosis and dosing for the treatment of SVT.

The primary objective is to evaluate physicians' adherence to fondaparinux prescribing information for the treatment of patients with SVT without concomitant DVT.

The study is designed as a non-interventional, retrospective chart review of patients prescribed fondaparinux to treat their SVT. The study will be conducted in several EU countries.

ARIXTRA® is a registered trademark of the GlaxoSmithKline group of companies.
Not Provided
Observational
Time Perspective: Retrospective
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Non-Probability Sample

Up to 12 clinical sites representative of geographical regions of several EU countries, targeting physician adherence to prescribing in approximately 840 patients with SVT.
Superficial Thrombophlebitis
Drug: Fondaparinux
Physician adherence study to Fondaparinux prescribing information for patients with Superficial Vein Thrombosis (SVT) of the lower limbs
Superficial Vein Thrombosis (SVT)
A representative of geographical regions of patients with Superficial Vein Thrombosis (SVT) who live in several EU countries.
Intervention: Drug: Fondaparinux
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of SVT
  • Prescribed fondaparinux for the treatment of SVT
  • Age 18 years or older

Exclusion Criteria:

  • Patients should not have been involved in any clinical trial that could influence SVT treatment during the observational period.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01691495
115280
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP