Odiparcil For The Prevention Of Venous Thromboembolism

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Pulmonary Embolism; Venous Thromboembolism; Deep Vein Thrombosis; Fibrillation, Atrial

Treatments: Drug: Warfarin; Drug: Odiparcil; Drug: Coumadin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00244725

ITI101711

Details and patient eligibility

About

Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.

Enrollment: 961 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women must be unable to have children.
• Will have a total knee replacement.

Exclusion criteria

• Allergic to any X-ray dye.
• Allergies or reactions to warfarin or coumadin.
• Previous VTE (venous thromboembolism) or deep vein thrombosis (DVT).
• On anticoagulation therapy.
• Renal impairment.
• Participated in any clinical trial in the past 30 days.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind