Last updated: 02/05/2019 16:10:31
Special Drug Use Investigation for Arixtra® (fondaparinux) Venous Thromboembolism Treatment
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation for Arixtra® (fondaparinux) Venous Thromboembolism Treatment
Trial description: The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE).("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of patients with adverse drug reaction
Timeframe: 3 months
Number of patients with any serious adverse event
Timeframe: 3 months
Number of patients with any hemorrhagic adverse event
Timeframe: 3 months
Presence or absence of reoccurrence of VTE
Timeframe: 3 months
Secondary outcomes:
Not applicable
Interventions:
Drug: Fondaparinux Sodium
Enrollment:
200
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Rie Otake, Takeshi Ebihara, Terufumi Hara, Pascal Yoshida.Evaluation of the Safety and Effectiveness of Fondaparinux Sodium (Arixtra®) Injection in Clinical Practice in Patients with Acute Pulmonary Embolism and Acute Deep Vein Thrombosis - The Report of Special Drug Use Investigation -.J Clin Therapeut Med.2016;33(1):21-32.
Medical condition
Ataxia
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
January 2012 to June 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Patients with acute pulmonary thromboembolism or acute deep venous thrombosis
- Fondaparinux injection must be prescribed for the first time
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with acute pulmonary thromboembolism or acute deep venous thrombosis
- Fondaparinux injection must be prescribed for the first time
Exclusion criteria:
- Not applicable
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2015-05-06
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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