Last updated: 03/05/2020 20:40:07
This study has been divested to Aspen, GSK will not produce a result

A Post Marketing Surveillance Study of Fondaparinux sodium (ARIXTRA) among Filipino Patients diagnosed with Acute Coronary Syndrome and Prophylaxis and Treatment of Venous Thromboembolism

GSK study ID
114499
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Post Marketing Surveillance Study of Fondaparinux sodium (ARIXTRA) among Filipino Patients diagnosed with Acute Coronary Syndrome and Prophylaxis and Treatment of Venous Thromboembolism
Trial description: This is a regulatory mandated study for ARIXTRA while on monitored release. The study is to run for three years and is to recruit 300 patients. Patients will obtain Arixtra by way of prescription under normal clinical conditions.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Safety reports

Timeframe: 7-14 days

Secondary outcomes:

None

Timeframe: None

Interventions:
Not applicable
Enrollment:
3000
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Infarction, Myocardial
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
June 2010 to December 2013
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18 - 100 Year
Accepts healthy volunteers
none
  • Adult Filipino patients diagnosed with Acute Coronary Syndrome or Venous Thromboembolism prescribed with ARIXTRA
  • Patients with Infective Endocarditis
  • Patients with active bleeding
Inclusion and exclusion criteria
Inclusion criteria:
  • Adult Filipino patients diagnosed with Acute Coronary Syndrome or Venous Thromboembolism prescribed with ARIXTRA
Exclusion criteria:
  • Patients with Infective Endocarditis
  • Patients with active bleeding
  • Patient with hypersensitivity to any of the components of ARIXTRA

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
2013-30-12

Plain language summaries

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

Additional information about the trial

Not applicable
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