Conditions: Venous Thromboembolism (VTE)
Keywords: Phase III
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7513
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.

Detailed description:

Arms:
arm 1: Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days arm 2: Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days

Interventions: intervention 1: Betrixaban intervention 2: Enoxaparin
Intervention descriptions: intervention 1: Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.

Enoxaparin Placebo: Once daily, 6-14 days intervention 2: Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.

Betrixaban Placebo: once daily, 35 days

Protocol document: