Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by GlaxoSmithKline.
Recruitment status was Not yet recruiting
Information provided by (Responsible Party):
First received: September 1, 2011
Last updated: June 6, 2013
Last verified: January 2012
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.)
Drug: Fondaparinux Sodium
||Time Perspective: Prospective
||Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
Patients prescribed fondaparinux
Drug: Fondaparinux Sodium
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Japanese patients with acute pulmonary thromboembolism or acute deep venous thrombosis
- Patients with acute pulmonary thromboembolism or acute deep venous thrombosis
- Fondaparinux injection must be prescribed for the first time
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428531
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 1, 2011
||June 6, 2013
||Japan: Pharmaceuticals and Medical Devices Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 29, 2014
Embolism and Thrombosis
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action