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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT : 2006-000152-41 |
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The primary objective is to:
The secondary objectives are to:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR123781A | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is a composite of total venous thromboembolic events (VTE) including VTE related deaths during the treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy endpoints will include all deep vein thrombosis events [DVTs] (proximal or distal) and all symptomatic VTEs (pulmonary embolisms [PEs] or DVTs) | ||
| The main safety criterion is the incidence of major bleedings occurring from the first study drug administration to 3 calendar days after the last study drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Rud Lassen, MD | Hoersholm Hospital, Spine Clinic, Usserod Kongevej 102, DK-2970 Hoerholm, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | San Isidro | Buenos Aires | 1642 | Argentina | ||
| Sanofi-Aventis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18402906 | Derived | Lassen MR, Dahl O, Mismetti P, Zielske D, Turpie AG. SR123781A: a new once-daily synthetic oligosaccharide anticoagulant for thromboprophylaxis after total hip replacement surgery: the DRIVE (Dose Ranging Study in Elective Total Hip Replacement Surgery) study. J Am Coll Cardiol. 2008 Apr 15;51(15):1498-504. doi: 10.1016/j.jacc.2008.03.007. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446839 | SR 123781A |
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| Sofia |
| 1715 |
| Bulgaria |
| Sanofi-Aventis | Providencia | Santiago Metropolitan | Chile |
| Sanofi-Aventis | Bogotá | Colombia |
| Sanofi-Aventis | Prague | 160 00 | Czechia |
| Sanofi-Aventis | Denmark | Denmark |
| Sanofi-Aventis | Helsinki | Finland |
| Sanofi-Aventis | México | 04000 | Mexico |
| Sanofi-Aventis | Oslo | Norway |
| Sanofi-Aventis | Warsaw | Poland |
| Sanofi-Aventis | Bucharest | 70334 | Romania |
| Sanofi-Aventis | Moscow | 101000 | Russia |
| Sanofi-Aventis | Bromma | Sweden |
| Sanofi-Aventis | Istanbul | 34394 | Turkey (Türkiye) |