| December 4, 2006 |
| April 20, 2009 |
| December 2006 |
| March 2009 (final data collection date for primary outcome measure) |
| All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ] |
| All clinically relevant bleedings during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment |
| Complete list of historical versions of study NCT00408239 on ClinicalTrials.gov Archive Site |
- Venous thromboembolism and/or bleeds [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
- Other safety assessments [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
- PK, PD variables [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
|
- Venous thromboembolism, bleedings, other safety assessments,
- PK, PD variables
|
| |
| Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement |
| Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement: A Randomized, Enoxaparin-Controlled, Open Label, Dose-Escalation Study |
Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery |
| |
| Phase II |
| Interventional |
| Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Thromboembolism |
- Drug: YM150
- Drug: enoxaparin
|
- Experimental: Dose regimen 1
- Experimental: Dose regimen 2
|
| |
| |
| Completed |
| 367 |
| March 2009 |
| March 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Scheduled for elective primary total knee replacement surgery
- Legal minimum age requirement ( country-specific)
- Written informed consent has been obtained
Exclusion Criteria:
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Indonesia, Japan, Korea, Republic of, Malaysia, Philippines, Singapore, Taiwan, Thailand |
| |
| NCT00408239 |
| Director, Astellas Pharma, Inc |
| 150-CL-029 |
| Astellas Pharma Inc |
|
| Study Chair: |
Central Contact |
Astellas Pharma Inc |
|
|
| Astellas Pharma Inc |
| April 2009 |