Hip Fracture Study of GSK576428 (Fondaparinux Sodium)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Thromboembolism

Treatments: Drug: Fondaparinux

Study type: Interventional

Funder types: Industry

Identifiers

NCT00320424

AR3106335

Details and patient eligibility

About

This study is requested by PMDA to confirm the efficacy and the safety for HFS.

Enrollment: 48 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing hip fracture surgery within 10 days following the time of fracture of the hip (proximal femur) (or following the time of fracture estimated from trauma).

Exclusion criteria

• Active, clinically significant bleeding (excluding drainage).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)