Last updated: 11/03/2018 17:47:10

ARIXTRA® Adherence in SVT Patients.

GSK study ID
115280
Clinicaltrials.gov ID
NCT01691495
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: ARIXTRA® Physician Adherence to the Prescribing Information in isolated superficial vein thrombosis (SVT) Patients.
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The primary outcome will be a measure of physician adherence.

Timeframe: 2

Secondary outcomes:
Not applicable
Interventions:
Drug: Fondaparinux
Enrollment:
1
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Thrombosis, Venous
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
October 2012 to August 2014
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Diagnosis of SVT
  • Prescribed fondaparinux for the treatment of SVT
  • Patients should not have been involved in any clinical trial that
  • could influence SVT treatment during the observational period.
Inclusion and exclusion criteria
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.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2014-26-08

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website