Venous Thromboembolism Clinical Trial
Official title:
Dose Ranging Trial for the Evaluation of the Safety and Efficacy of GW813893 in the Prophylaxis of Venous Thromboembolism Post Total Knee Replacement Surgery.
| NCT number | NCT00541320 |
| Other study ID # | FTI102595 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 2 |
| First received | February 12, 2007 |
| Last updated | April 1, 2013 |
| Start date | February 2007 |
| Verified date | April 2013 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s) and dose regimen of GW813893 for future investigation.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion criteria: - Patients who are scheduled for primary elective unilateral total knee arthroplasty. Exclusion criteria: - Women who are not surgically sterile or post-menopausal - Have a contra-indication to contract venography - Have a known disorder associated with increased risk of bleeding or have been immobile up to 12 weeks before surgery. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Clinical Trials Call Center | Birmingham | Alabama |
| United States | GSK Clinical Trials Call Center | Charleston | South Carolina |
| United States | GSK Clinical Trials Call Center | Decatur | Georgia |
| United States | GSK Clinical Trials Call Center | Phoenix | Arizona |
| United States | GSK Clinical Trials Call Center` | Phoenix | Arizona |
| United States | GSK Clinical Trials Call Center | San Antonio | Texas |
| United States | GSK Clinical Trials Call Center | St. Petersburg | Florida |
| United States | GSK Clinical Trials Call Center | Yuba City | California |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of death OR symptomatic or non-symptomatic blood clots in the legs OR symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery. | symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery. | ||
| Secondary | Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery. | Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery |
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