drugset / Trial / NCT00345618
Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach
RandomizedParallel-groupTriple-blindTreatment
Summary
Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.
Timeline
- Start
- 2006-06
- Primary completion
- 2010-10
- Completion
- 2010-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Idrabiotaparinux sodium | Unknown | 3 mg | Subcutaneous |
| Subject | Warfarin | Small molecule | 1 mg | Oral |
| Subject | Warfarin | Small molecule | 5 mg | Oral |
| Background | Avidin | Unknown | 100 mg | Intravenous |
| Background | Enoxaparin sodium | Other / unclassified | 1 mg/kg | Subcutaneous |