Last updated: 11/07/2018 09:34:14
Special Drug Use Investigation (retrospective) for Arixtra® (fondaparinux) Venous Thromboembolism Treatment (over 100kg)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation (retrospective) for Arixtra® (fondaparinux) Venous Thromboembolism Treatment (over 100kg)
Trial description: The purpose of this post-marketing surveillance study is to collect and assess information retrospectively on safety and effectiveness of fondaparinux injection in patients with venous thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom fondaparinux was injected 10 mg/day. ("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:
5
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
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)
March 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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