Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00244725 | Odiparcil For The Prevention Of Venous Thromboembolism | PHASE2 | COMPLETED | 961 | — | — | Sep 1, 2005 | Sep 1, 2006 | May 2, 2017 | 101 | United States, Australia +11 |
Participants were assessed for VTE at all study visits and at the end of study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study did not receive a mandatory bilateral venogram following at least 8 days on study medication. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if he/ she experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or pulmonary embolism (PE) at any time during study treatment or death adjudicated to be related to VTE during study treatment.
| Name | Type | Description |
|---|---|---|
| Odiparcil | DRUG | - |
| Warfarin | DRUG | - |
| Coumadin | DRUG | - |
Inclusion Criteria: * Women must be unable to have children. * Will have a total knee replacement. Exclusion Criteria: * Allergic to any X-ray dye. * Allergies or reactions to warfarin or coumadin. * Previous VTE (venous thromboembolism) or deep vein thrombosis (DVT). * On anticoagulation therapy...