Emisphere Technologies has received written guidance from the FDA regarding the company's planned Phase III trial with oral heparin. The planned trial is designed to determine the safety and efficacy of oral heparin versus titrated Coumadin (sodium warfarin) for the prevention of venous thromboembolism (VTE) following elective total hip replacement.
The trial will be a randomized, double-blind, non-inferiority, multicenter study with the primary endpoint to prevent VTE, which consists of deep venous thrombosis, objectively confirmed by ultrasound, pulmonary embolism and death. The two-arm study will compare 30 days of dosing, three times per day, of two Emisphere oral heparin capsules, to 30 days of dosing, once per day, of oral titrated Coumadin. The expected enrollment for the trial is approximately 2,100 patients (including an allowance for non-evaluable patients), with 1,050 patients per arm.