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Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01428544
First received: September 1, 2011
Last updated: June 13, 2013
Last verified: June 2013
History of Changes

September 1, 2011
June 13, 2013
March 2012
October 2014   (final data collection date for primary outcome measure)
  • Number of patients with adverse drug reaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of patients with any serious adverse event [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of patients with any hemorrhagic adverse event [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Presence or absence of reoccurrence of VTE [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of patients with adverse drug reaction [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Number of patients with any serious adverse event [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Number of patients with any hemorrhagic adverse event [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Presence or absence of reoccurrence of VTE [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01428544 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)
Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)

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.)
Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Japanese patients with acute pulmonary thromboembolism or acute deep venous thrombosis whose body weight is 100 kg or more, or to whom fondaparinux was injected 10 mg/day.
Ataxia
Drug: Fondaparinux sodium
For patients whose body weight is 100 kg or more, fondaparinux is injected 10 mg subcutaneously once daily for treatment of acute pulmonary thromboembolism or acute deep venous thrombosis.
Patients with VTE treated with fondaparinux
Patients with VTE treated with fondaparinux
Intervention: Drug: Fondaparinux sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
July 2015
October 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01428544
115490
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP