PROTECT Phase III Overview
Endpoint: To determine superiority of UF heparin dosed for 30 days orally compared to Lovenox® dosed for 10 days by injection, in the prevention of DVT when measured by venogram at 30 days following total hip replacement surgery
Total Randomized Patients = 2288
Multi-national study
- 100 centers in the U.S., Canada, U.K., Spain, Eastern Europe, and Australia
Double-blinded, double-dummy
1. Oral solution: SNAC/Heparin 60K Us (12 mls)
2. Oral solution: SNAC/Heparin 90K Us (18 mls)
3. Injection: enoxaparin 30mg, and oral placebo