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Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)

Primary Purpose

Venous Thromboembolism

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GW813893
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Anti-thrombolytic direct Factor Xa inhibitor

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center'
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery.

Full Information

First Posted
February 12, 2007
Last Updated
April 1, 2013
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00541320
Brief Title
Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Withdrawn
Why Stopped
No longer viable
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Anti-thrombolytic direct Factor Xa inhibitor

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW813893
Primary Outcome Measure Information:
Title
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.
Time Frame
symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.
Secondary Outcome Measure Information:
Title
Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery.
Time Frame
Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
GSK Clinical Trials Call Center'
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Yuba City
State/Province
California
ZIP/Postal Code
95991
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30032
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)

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