Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: GSK576428; Drug: Fondaparinux sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333021

AR3106116

Details and patient eligibility

About

This study is phase 3 study for prevention of VTE in patients with abdominal surgery.

Enrollment: 127 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged >=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
• General or urologic surgery
• Cancer surgery
• Gynecologic surgery
• Radical surgery for pelvic malignancy

Exclusion criteria

• Active, clinically significant bleeding Thrombocytopenia Body weight <40kg

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)