Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01428531
• Date of registration: 01/09/2011
• Primary sponsor: GlaxoSmithKline
• Public title: Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment
• Scientific title: Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment
• Date of first enrolment: January 2012
• Target sample size: 200
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01428531
• Study type: Observational
• Study design: Time Perspective: Prospective

Contacts

• Name: US GSK Clinical Trials Call Center

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & 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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Venous Thromboembolism

Intervention(s)

Drug: Fondaparinux Sodium

Primary Outcome(s)

Number of patients with adverse drug reaction [Time Frame: 3 months]

Number of patients with any hemorrhagic adverse event [Time Frame: 3 months]

Number of patients with any serious adverse event [Time Frame: 3 months]

Presence or absence of reoccurrence of VTE [Time Frame: 3 months]

Secondary ID(s)

115489

Source(s) of Monetary Support

Please refer to primary and secondary sponsors