NCT01428544

Brief Summary

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.)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

3.3 years

First QC Date

September 1, 2011

Last Update Submit

July 13, 2015

Conditions

Ataxia

Outcome Measures

Primary Outcomes (4)

  • Number of patients with adverse drug reaction

    3 months

  • Number of patients with any serious adverse event

    3 months

  • Number of patients with any hemorrhagic adverse event

    3 months

  • Presence or absence of reoccurrence of VTE

    3 months

Study Arms (1)

Patients with VTE treated with fondaparinux

Patients with VTE treated with fondaparinux

Drug: Fondaparinux sodium

Interventions

Fondaparinux sodiumDRUG

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • Patients with acute pulmonary thromboembolism or acute deep venous thrombosis
  • Fondaparinux injection must be prescribed for the first time

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ataxia

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 5, 2011

Study Start

March 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 15, 2015

Record last verified: 2015-07