drugset / Trial / NCT00152971
Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement
RandomizedParallel-groupDouble-blindPrevention
Summary
To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery
Timeline
- Start
- 2004-11
- Primary completion
- 2006-06
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabigatran etexilate | Unknown | 75 mg | Oral |
| Subject | Dabigatran etexilate | Unknown | 110 mg | Oral |
| Subject | Dabigatran etexilate | Unknown | 150 mg | Oral |
| Subject | Dabigatran etexilate | Unknown | 220 mg | Oral |
| Comparator | Enoxaparin sodium | Other / unclassified | 30 mg | Subcutaneous |