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| Sponsored by: |
Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00332020 |
Purpose
The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.
| Condition | Intervention | Phase |
|---|---|---|
|
Prevention Venous Thromboembolism |
Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | RECORD 2 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-Blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Hip Replacement. |
| Enrollment: | 2509 |
| Study Start Date: | February 2006 |
| Study Completion Date: | May 2007 |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Drug: Rivaroxaban (BAY59-7939)
10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days
|
| Arm 2: Active Comparator |
Drug: Enoxaparin
40 mg enoxaparin syringe administered for 12 +/- 2 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 126 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head ) |
| Study ID Numbers: | 11357, EudraCT: 2005-004691-20 |
| Study First Received: | May 30, 2006 |
| Last Updated: | January 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00332020 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Fibrin Modulating Agents Embolism and Thrombosis Anticoagulants Embolism Vascular Diseases Fibrinolytic Agents |
Cardiovascular Agents Venous Thromboembolism Thrombosis Thromboembolism Enoxaparin |
|
Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Agents Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Venous Thromboembolism Thromboembolism |
Thrombosis Pharmacologic Actions Enoxaparin Embolism and Thrombosis Fibrin Modulating Agents Therapeutic Uses Cardiovascular Diseases |