A Randomized, Double-blind, Placebo-controlled Study of Apixaban for the Prevention of Thromboembolic Events in Patients Undergoing Treatment for Advanced Cancer: A Phase 2 Pilot Study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

The occurrence of either a major bleeding (fatal or non-fatal) event or a clinically relevant non-major bleeding event

Outcome Time Frame:

during the treatment period

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CV185-027

NCT ID:

NCT00320255

Start Date:

June 2006

Completion Date:

January 2009

Related Keywords:

• Thrombosis
• Cancer
• Pulmonary Embolism
• anticoagulant
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis